Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic

Abstract

The aim of this longitudinal multisite randomized controlled trial (RCT), using a treatment as usual (TAU) control group design, was to evaluate the effectiveness of the Acute Stress Syndrome Stabilization Remote for Groups (ASSYST-RG) procedure in reducing posttraumatic stress disorder (PTSD), depression, and anxiety symptoms in the general population during the COVID-19 pandemic lockdown in Mexico. A total of 63 adults (60 females and 3 males) met the inclusion criteria. Participants’ ages ranged from 21 to 73 years old (M =43.09 years). Significant differences between groups were found in all variables. Differences between groups were maintained at follow up assessment. ANOVA for repeated-measures (pre-treatment, post-treatment and follow-up) showed that the ASSYST-RG had a significant effect to reduce Posttraumatic Stress Disorder (F (2, 122) = 22.40 p <.000, ηP2 = .269). Anxiety and depression showed a significant interaction effect for time and group (F (1, 61) = 8.89, p <.00, ηP2= .127) and (F (2, 122) = 35.04, p <.001, ηP2 = .365) respectively. No adverse effects or events were reported by the participants during the procedure administration or at three months follow-up while all participants were still in lockdown. None of the participants showed clinically significant worsening/exacerbation of symptoms after the procedure. This randomized controlled trial provides evidence for the effectiveness, efficacy, feasibility, and safety of the ASSYST-RG in reducing posttraumatic stress, anxiety, and depression symptoms in the general population during the COVID-19 pandemic lockdown.

Full text

Research article
Volume 16 Issue 2 - January 2021
DOI: 10.19080/PBSIJ.2021.16.555931
Psychol Behav Sci Int J
Copyright © All rights are reserved by Ignacio Jarero
Longitudinal Multisite Randomized
Controlled Trial on the Provision of the Acute
Stress Syndrome Stabilization Remote for Groups
to General Population in Lockdown During the
COVID-19 Pandemic
Becker Yael1, Estévez María Elena1, Pérez María Cristina2, Osorio Amalia2, Jarero Ignacio1*, and Givaudan
Martha1
1Department of Research, Mexican Association for Mental Health Support in Crisis, Mexico
2Department of Research, Ágape Desarrollo Integral, Puebla, Mexico
Submission: November 17, 2020; Published: January 18, 2021
*Corresponding author: Ignacio Jarero, Department of Research, Mexican Association for Mental Health Support in Crisis, Mexico City, Mexico
Psychology and Behavioral Science
International Journal
ISSN 2474-7688
Psychol Behav Sci Int J 16(2) PBSIJ.MS.ID.555931 (2021) 001
Introduction
On October 26, 2020, the World Health Organization
      

 
        
       
           

  


         
      
           
travel restrictions) and increased hygienic practices, especially
        
        
      
Abstract
            
             


                
  
Stress Disorder (F (2, 122) = 22.40 p <.000, ηP
2
= 8.89, p <.00, ηP
2= .127) and (F (2, 122) = 35.04, p <.001, ηP
2

              


Keywords:



Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
002
         

 
respondents, found rates of 30% of anxiety, 17% of depression,
      
      
        
of adults from the general population of the Republic of Ireland
      

    
       
    
        
6th, 2020, 18,147 individuals completed the questionnaire.

depression, anxiety, insomnia, perceived stress, and adjustment

        

         
  
       
Insights (PSI), reported their results of an ongoing longitudinal
       
        
       
also indicate that individuals of the female sex, of younger age,
        
         
           

  
  
      
    
    
     
     
order to survey and develop possible measurements to reduce the

Adaptive information processing theoretical model
      

      

are the basis of both human mental health and human pathology
across the clinical spectrum. According to Dr. Francine Shapiro,
all human beings have an innate physical information processing
         
       
is successfully processed, it is adaptively stored in memory
        
(e.g., sensory input, emotions/feelings, body/somatic sensations).
       
       
       
to high arousal states from critical incidents or adverse life
experiences result in memories that are inadequately processed
       
   
  
     
  
the clinical spectrum (not only posttraumatic stress disorder).

information from the present and the person reacts to the present


     


Syndrome and mental disorder
        
“A group of symptoms that together are characteristics of a
   
      
in an individual’s cognitive, emotion regulation, or behavior
        
developmental process underlying mental functioning. Mental


Acute stress disorder and posttraumatic stress disorder
According to the Diagnostic and Statistical Manual of Mental
Disorders (5th    
     
        


“is the development of characteristic symptoms lasting from 3
          
         
symptoms, 2) Negative Mood, 3) Dissociative symptoms, 4)
        

         
mentioned. It is important to notice that “Approximately half of
  

       
occurring after exposure to one or more traumatic events
(Criterion A) and is characterized by intense reliving of the

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
003
traumatic event through intrusive memories and nightmares
(intrusion symptoms; criterion B); avoidance of reminders of the
event (avoidance symptoms; criterion C); negative alterations
        
       
       
    
Criteria A events included, but are not limited to, threatened or
actual physical assault (e.g., childhood physical abuse, physical
       
  
       

       
      
        
Recurrent, involuntary, and intrusive distressing memories of the

content and/or affect of the dream are related to the traumatic
    

4. Intense or prolonged psychological distress at exposure to
internal or external cues that symbolize or resemble an aspect
        
internal or external clues that symbolize or resemble an aspect of
  
          



       
intrusive memories of the event itself, but instead experience
      
they are exposed to triggering events that resemble or symbolize

Acute stress syndrome stabilization procedures

in both a group and individual formats, are Adaptive Information
     

      
      
       
     
        

      
or physiological/somatic reactivity caused by the disorder’s
intrusion symptoms (e.g., sensory, emotional, or physiological/
   



        
sensory inputs, body/somatic sensations, emotions/feelings,
 
           
        
distress, physiological reactivity, and/or deterioration in current
        
the client’s nervous system activation regulation (stabilization)
through the reduction (desensitization) or removal of the
activation produced by the sensory, emotional, or physiological
     
pathogenic memories of adverse experiences, to achieve optimal
levels of nervous system activation; thus, facilitating the AIP
system the subsequent adaptive processing of the information.
       
reduction of distress and adaptive functioning objectives and


manner) to help the person achieve a state of adaptive functioning

         

Objective
      
         

and anxiety symptoms in the general population during the

Method
Study Design
        
       
        

   
         


Ethics and Research quality
        
   



 
          


Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
004
       
the Standard Protocol Items Recommendation for Interventional

Participants






(c) voluntarily participating in the study, (d) not receiving
specialized trauma therapy, (e) not receiving drug therapy for




of schizophrenia, psychotic or bipolar disorder, (e) diagnosis of
dissociative disorder, (f) organic mental disorder, (g) a current,
      
impairment (e.g., severe intellectual disability, dementia), (i)
presence of uncontrolled symptoms due to a medical illness.
Blind randomization, allocation concealment
mechanism, and blinding procedure
      
        
blind to treatment conditions conducted the randomization
        

          

       
    
         
overseen by an independent person not involved in the research
        
for the research assistants (all mental health professionals)
        
         
       

instead of their name to protect their identity. An independent
    

      

3 males) met the inclusion criteria. Participants’ ages ranged from
 

         
          
          

Figure 1: Mean scores and standard error for PTSD symptoms by time and group

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
005
Flow Diagram
Instruments for psychometric evaluation
i.       
        
        
          
        
      

      
       
         

all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. A
  
          
        
       

          
          

  
      
       
       

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
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         
       
        
           
   
      
currently bothered them the most; then at each subsequent

ii.   
been extensively used to evaluate these psychiatric comorbidities
in various clinical settings at all levels of healthcare services
        
         
report scale to measure the anxiety (7 items) and depression (7



No, not much (score 1); No, not at all (score 0). A higher score
represents higher levels of anxiety and depression: a domain
score of 11 or greater indicates anxiety or depression; 8–10

or depression.
Procedure
Enrollment, assessments times, blind data collection,

    
        
        
       
the three different assessment times. During time 1, research
assistants (all mental health professionals) blind to treatment
       
potential participants for eligibility based on the inclusion/
exclusion criteria, collected their personal data (e.g., name,
age, gender, profession, email, telephone), obtained signed
informed consent, enrolled participants in the study, sent the
        
and sent only the participant’s name and email to the treatment
       
previous randomization, the treatment allocation envelope’s
   

assessment instruments online, their ID codes, and the treatment
        
names, ID codes, and participant’s allocation on each arm of the

       
independent assessor, using telephone, Whatsapp messages and
    


       
       
completion (instead of 180 days) to assess participants still
      

         
      
 
          
quality control. All procedures for handling, storing, destroying

         

Withdrawal from the study
  

       
  
 
Diagram.
Treatment

          
session per group by eight licensed clinicians (four for each

        
      
        
        
        
and adherence to all steps of the procedures.
Treatment description and safety measure
      
     
received an average of 60 minutes of online treatment, provided
         
        
     
 
       
only on the distressing memories related to their experience
          
      
     
       
each of the participants to, “Run a mental movie of everything

          
    

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
007

         
distressing, noticing associated emotions/feelings and body

  
method to process the intrusive distressing memories. Most

       
immediately report to the clinician’s coordinator any adverse
effects (e.g., symptoms of dissociation, fear, panic, freeze, shut
       


Examples of worst experiences reprocessed during the
online treatment
     
        

    
fear of everything or in general (losing my job, a family member
  
         
virus. Contracting the virus and having to spend time isolated in
the hospital. Dying alone in the hospital.
Statistical analysis
      


         


PTSD
       
   
for time (F (2, 122) = 22.40 p <.000, ηP
2
for group (F (1, 61 = 8.42, p<.005, η
P
2    

ηP
2 



  
    

           
    

         
Figure 1.
Table 1: Mean scores (M) and standard deviations (SD) for Treatment
Group (T) and Treatment as usual group (TAU), on Pre-treatment,
Post-treatment, and Follow-up assessments.
Time 1 Time 2 Time 3
M SD M SD M SD
PTSD
27.16 9.48 18.54 10.42 15.25 8.14
 27.28 8.33 25.78 11.17 26.00 9.06
Anxiety
10.77 4.52 8.51 4.17 8.32 3.20
 10.56 2.77 11.15 2.59 12.03 2.00
Depression
5.58 3.22 3.83 2.87 3.67 2.31
 5.50 2.40 7.37 3.26 8.53 2.73
Figure 2: Mean scores and standard error for Anxiety by time and group.

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
008
Anxiety

          
         ηP
2    

p<.001, ηP
2        
       
    
d
     
 d  
        
      
t (30) = 2.76, p<.01, d    
        
 
        
   d= 
Figure 2.
Depression
        
     
      
p <.001, ηP
2         
20.02, p<.001, ηP
2      

     
  d = 1.15 and
 d      
       
          
p<.001, d       
 
         
  d  
4.28, p<.001, d
Figure 3: Mean scores and standard error for Depression by time and group.
Safety and symptoms worsening

        
      
reported by the participants during treatment or at three months
       

      
the study frame.
Discussion
  

        
      
     

     
and 3 males) met the inclusion criteria. Participants’ ages
ranged from 21 to 73 years old (M =43.09 years). Participation
  

        

        


Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
009
     

      
      
       
       
    
          

       
to the Acute Stress Syndrome Stabilization Remote for Groups
        
    
   
after the treatment and the level of anxiety did not increase in the

        
          
increase in the mean. In the case of Depression, a similar pattern


   
group that received treatment as usual, the scores for depression

        

  

that received treatment as usual. In the case of depression, there


that received the treatment as usual, as a control group, the scores
of depression gradually increased, probably due to the losses and
   

            
creates fear, anxiety and uncertainty, also the economic recession
        
         
became more prone to mental disorders due to restriction of
freedom of movement.
      
      
        
           
          
         
      
      
based psychotherapies to treat mental disorders, mental health
conditions, or prolonged adverse experiences (e.g., ongoing or
prolonged traumatic stress) in the general population is still in
        
        
         
         
     
effective online approaches for the resolution of memories of
adverse experiences producing the pathogenic symptoms, that
       

       
approaches must be minimally intrusive, not requiring a detailed

of details, the prolonged reliving of traumatic experiences, or
      
       
there are still barriers to address because there are places in
       


            
       
the emotional crisis they are facing due to the situation caused by


Conclusion, Limitations, and Future Directions
      
 
disorder, posttraumatic stress symptoms, anxiety, depression,
insomnia, perceived stress, and adjustment disorder symptoms,
independently from previous mental illness or childhood trauma.
       
  
       

effectively and safely be provided online in a group format to the

         

   
reduce anguish during a crisis at a distance. We believe that this


          




References
1.       
Situation Report 115.
2. 

Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
0010
       

3.     
        

4.      


5. 
Responses and Associated Factors during the Initial Stage of the
      

6. 
        
epidemic: Implications and policy recommendations. Gen Psychiatry

7.     
Posttraumatic Stress Symptoms and Associated Comorbidity During


8.              
       
the General Population in Italy. Front Psychiatry 11: 790.
9. Mental Health Research Canada (2020) National poll on impact of

10.           

11.     

12. 
   
         

13.       
Basic principles, protocols, and procedures (3rd 

14. Centonze D, Siracusane A, Calabresi P, Bernardi G (2005) Removing
pathogenic memories: a neurobiology of psychotherapy. Mol Neurobiol

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         
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18.          
     nd 
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19.          


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20.         ño MA, et al. (2020)
        
        
         

21.         
    


22. 



23. 
critical incidents: A randomized controlled trial in a technological

24.   

25.       
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26.       

27. 
        
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    
         
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         
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30.            


31.   


32.         

33. 
    

34.            


35.          
socioeconomic and mental health aspects in Nepal. International

36.          
  

37.  
        
     
Psychologist. Advance online publication.
38.             
     
      
   



Psychology and Behavioral Science International Journal
How to cite: Becker Y, Estévez M E, Pérez M C, Osorio A, Jarero I. Longitudinal Multisite Randomized Controlled Trial on the Provision of the Acute Stress
Syndrome Stabilization Remote for Groups to General Population in Lockdown During the COVID-19 Pandemic. Psychol Behav Sci Int J .2021; 16(2): 555931.
DOI: 10.19080/PBSIJ.2021.16.555931
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39. Zhai Y (2020) A call for addressing barriers to telemedicine: health
      
Psychosomatics, 1.
40. 
cultivating emotional, social, and ecological intelligence. John Wiley &
Sons.
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DOI:10.19080/PBSIJ.2021.16.555931