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Background Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members), and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support. Treatment outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) put emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? Methods This is a pragmatic, parallel, two-arm, feasibility RCT comparing the clinical and cost-effectiveness of SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community services in London. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. Results We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n=54.5) versus control (n=41.5). Discussion The results of this feasibility trial indicate that with the appropriate modifications, a full multi centred trial would be possible to test the effectiveness and cost-effectiveness of a pre- habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. Trial Registration Name of registry: ISRCTN; Trial Registration Number: 14621127; Date of Registration: 22/02/2017; URL of trial registry record: http://www.isrctn.com/ISRCTN14621127
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A Feasibility Study of an Intervention for Structured
Preparation Before Detoxication in Alcohol
Dependence: the SPADe Trial Results
Christos KOUIMTSIDIS ( drckouimtsidis@hotmail.com )
Surrey and Borders Partnership NHS Foundation Trust https://orcid.org/0000-0001-9975-2955
Ben Houghton
Surrey and Borders Partnership NHS Foundation Trust
Heather Gage
University of Surrey
Caitlin Notley
University of East Anglia School of Health Sciences
Vivienne Maskrey
University of East Anglia School of Health Sciences
Allan Clark
University of East Anglia School of Health Sciences
Richard Holland
University of Leicester Medical School
Anne Anne Lingford-Hughes
Imperial College London
Bhaskar Bhaskar Punukollu
Camden and Islington NHS Foundation Trust
Morro Morro Touray
University of Surrey
Theodora Duka
University of Sussex
Research
Keywords: Alcohol dependence, detoxication, structured preparation, pre-habilitation, SPADe
DOI: https://doi.org/10.21203/rs.3.rs-32361/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License. 
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Abstract
Background
Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a
severe impact on their own health and mortality, the health and behaviours of others (family members),
and to have economic and social implications. Treatment guidelines suggest that treatment needs to be
planned with medically assisted withdrawal (also referred to as detoxication), and aftercare support.
Treatment outcomes are poor with low proportions engaging in after care and high relapse rates. An
approach of structured preparation before alcohol detoxication (SPADe) put emphasis on introducing
lifestyle changes, development of coping strategies for cravings, stress and emotions as well as
introducing changes to the immediate family and social environment in advance of alcohol cessation.
Such a pre-habilitation paradigm compliments the established treatment approach. The key research
question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether
such an approach is more effective than usual care in helping individuals to maintain longer periods of
alcohol abstinence?
Methods
This is a pragmatic, parallel, two-arm, feasibility RCT comparing the clinical and cost-effectiveness of
SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol
dependence receiving care in two community services in London. The trial follows the guidelines of
phase 2 of the Medical Research Council (MRC) for complex interventions.
Results
We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial was 75%.
Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and
63% at 3, 6 and 12 months respectively. The intervention group had more days abstinent in the previous
90 days at the 12 months (n=54.5) versus control (n=41.5).
Discussion
The results of this feasibility trial indicate that with the appropriate modications, a full multi centred trial
would be possible to test the effectiveness and cost-effectiveness of a pre- habilitation approach such as
the SPADe group intervention in addition to usual care against usual care only.
Trial Registration
Name of registry: ISRCTN; Trial Registration Number: 14621127; Date of Registration: 22/02/2017; URL
of trial registry record: http://www.isrctn.com/ISRCTN14621127
Background
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Alcohol harmful use continues to be a global health problem. Tackling the impact of harmful and
dependent drinking is a key global public health priority. Global estimates suggest that one in ve adults
report at least one occasion of heavy episodic drinking in the past month [1]. In the UK hospital
admissions attributable to alcohol in 2017–2018 remained similar to the previous year (338,000).
However this is 15% higher than 10years ago [2]. Alcohol misuse is linked directly to a range of health
disorders. Cancer, accidental injuries and mental health problems remain the main alcohol related
diagnosis leading to a hospital admission [2]. More than ve thousand people died directly from alcohol
use in 2016 in the UK, which is 6% higher than 10years ago [2]. However in the year 2018–2019, in the UK
those in treatment for alcohol alone remained stable as the previous year (75,787). This follows large
year-on-year declines from a peak of 91,651 in 2013 to 2014 [3]. Individuals who are ‘moderately’ or
severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health
and mortality, the health and behaviours of others (family members), and to have economic and social
implications [4].
Treatment guidelines in the UK for moderate to severe alcohol dependence have largely remained the
same for the past decade. They suggest that treatment needs to be planned, with up to four motivational
sessions focusing on treatment engagement and development of aftercare support, followed by
medically assisted withdrawal (also referred to as detoxication), and nally aftercare support, which
should include pharmacological, psychological and access to self-help interventions and support [4].
Benzodiazepines are normally prescribed during detoxication to reduce the overt symptoms of alcohol
withdrawal (sweats, tremor) as well as prevent potentially life-threatening complications (e.g.
convulsions, delirium tremens) [4]. However, these drugs do not prevent alcohol craving, relapse back into
alcohol drinking and other long-term effects on mental functioning [4, 5]. Outcomes from detoxication
are often poor with low proportions engaging in after care [6] and high relapse rates [4]. There is
accumulating evidence from animal and human studies that exposure to multiple detoxications is
associated, with cognitive and behaviour changes indicating inability in conict resolution and increased
sensitivity to stress, both of which may contribute to relapse and might compromise the effectiveness of
aftercare support [7–11]. There is also evidence to suggest that multiple detoxications can exacerbate
craving, adversely impacting on subsequent attempts at achieving abstinence [12].
In the light of this evidence indicating risks associated with the process of detoxication itself, one
potential approach to maximise effectiveness of each treatment episode, may be following a pre-
habilitation treatment paradigm that compliments the established treatment and rehabilitation paradigm.
Such an enhanced paradigm takes into account and plans in advance for the management of the risks
associated with the detoxication process as well as the risk factors associated with relapse. Such an
approach of structured preparation puts emphasis on introducing lifestyle changes, development of
coping strategies for cravings, stress and emotions as well as introducing changes to the immediate
family and social environment in advance of alcohol cessation. There is currently no guidance
specically on preparation for the detoxication process, apart from general guidance on care
coordination and case management [4]. Absence of specic guidance reects the lack of developed
interventions in this area. Evidence is required on whether structured preparation along the lines of pre-
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habilitation principles before detoxication rather than detoxication alone improves treatment outcomes
short and long term and therefore whether the whole treatment paradigm should shift. Before embarking
on a full trial of the effectiveness of such structured preparation, there is a need to undertake a feasibility
study to establish key parameters that inuence trial design such as recruitment, adherence to the
intervention, retention, and sensitivity of alternative outcome measures.
A literature search of PubMed Central using alcohol relapse prevention treatment related MeSH terms
undertaken in June 2014, found (i) that group interventions with diverse theoretical bases are considered
to be more cost-effective than one-to-one interventions; and (ii) Cognitive Behaviour Therapy (CBT)
Relapse Prevention interventions are well supported by evidence [13].
In the UK an innovative group intervention for preparation before alcohol detoxication, based on CBT
Relapse Prevention interventions, developed by members of the research team, reduced detox drop outs
[14], and improved outcomes at 1, 3 months (5) and 6 months [15]. However, these ndings were from
small naturalistic studies. Qualitative evidence found that ‘regaining control’ was the main learning point
across all group sessions of the programme [16].
This feasibility study built on the above preliminary evidence and aimed to rene the preparatory
intervention and assess the feasibility of conducting a large scale evaluation (Structured Preparation
before Alcohol Detoxication: SPADe) for people with moderate to severe alcohol dependence, as an
adjunct to usual care, consisting of planned detoxication and aftercare.
The intervention under investigation in this study is based on Plans, Responses, Impulses, Motives,
Evaluations (PRIME) theory of motivation [17] and Learning theories [18] that underlie the use of
psychological interventions aiming to reverse the development of automatised behaviour and associated
loss of control, such as CBT Relapse Prevention interventions. It combines the long established (in
alcohol treatment) ethos of group intervention, and follows the biological principle of homeostasis, which
is disturbed with prolonged alcohol use [19], in order to help individuals to regain control over drinking as
the rst step towards lifelong sustainable abstinence.
Objectives
The key research question was: can we design a large scale, randomised controlled trial (RCT) that will
answer whether the SPADe intervention is more effective than usual care in helping adults to maintain
longer periods of alcohol abstinence? The feasibility trial compared the use of SPADe with usual care
against usual care alone in the participating sites and enabled us to do the following:
1. 1. Measure the number of eligible participants, willingness of clinicians to recruit participants,
recruitment rate, loss to follow-up, adherence to the intervention, and standard deviation of the
primary outcome measures. This will ultimately inform the sample size calculation for a multicentre
clinical trial.
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2. 2. Determine the acceptability of randomisation to service users, through its effect on recruitment,
dropout rates and via qualitative interviews.
3. 3. Determine, through response rates to questionnaires, the appropriateness and the acceptability of
the outcome measures to participants, in order to explore the suitability of our chosen secondary
outcome measures, that is, percentage of days abstinent, service use and health-related quality of
life.
4. 4. Estimate the time needed to collect and analyse baseline and outcome data
5. 5. Explore the utility of the health-related quality of life instrument (EQ-5D-5L) (see outcome
measures below) in allowing the estimation of quality adjusted life years in the sample.
Furthermore reduction in subjective measures of alcohol dependence and craving as well as
improvement in objective measures of mental functioning were explored. Finally, we have conducted
qualitative interviews with participants and service providers, to assess the acceptability of the treatment
and to explore their experience of the treatment including any barriers and/ or facilitators to taking part in
the study. Findings from these interviews will enable us to rene the SPADe intervention and the design of
the future denitive RCT. Methodology and results of the qualitative interviews will be reported in detail
separately.
Methods
Trial Design
The study design is reported in detail elsewhere [20]. This is a parallel, two-arm, feasibility RCT comparing
the clinical and cost-effectiveness of SPADe and usual care, against usual care only, in maintaining
alcohol abstinence in adults with alcohol dependence receiving care in the community. The trial follows
the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions [21] and
includes: adaptation of the intervention, feasibility study including health economics, and process
evaluation. No changes of the protocol trial design has taken place.
Assessments
Participant assessments were conducted at baseline and at 3, 6 and 12 months by the research
assistants (RAs) who were trained in assessing capacity and obtaining consent, promoting the study,
administering the questionnaires, and interviewing participants. A window of two weeks at either side of
the assessment due points was endorsed in order to maximise engagement with follow up.
Participants
Inclusion criteria
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1. 1. Presentation to either of the two alcohol services in London (Hounslow, site 1 and Camden, site 2)
seeking abstinence from alcohol.
2. 2. Alcohol dependence (moderate to severe), scoring 16 and above on Severity of Alcohol
Dependence Questionnaire (SADQ) (see outcome measures below). This level of dependence
indicates that it would be clinically appropriate to receive a medically assisted detoxication (4).
3. 3. Stated intention to stay in the area within the time period of the intervention.
4. 4. Willingness to be part of a group intervention if randomised to receive it.
Exclusion criteria
1. 1. Age less than 18 (as not usually treated by specialist alcohol services).
2. 2. Pregnancy: pregnant women need urgent intervention to withdraw from alcohol, due to the effect
of alcohol on the foetus.
3. 3. Known terminal illness with life expectancy of less than 6 months.
4. 4. Severe medical condition that requires urgent medical admission, which would lead to an
unplanned medically assisted withdrawal.
5. 5. Severe cognitive impairment that compromises capacity and /or ability to participate in a group
intervention.
6. 6. Acute stage of severe and enduring mental illness (schizophrenia, Bipolar Affective Disorder,
recurrent depressive disorder: current episode severe), when acute symptomatology compromises
service users ability to participate in a group intervention.
Study Settings
Participants were recruited from specialist alcohol community services offering recovery orientated
treatment for people with Alcohol Use Disorders (AUD). Recruitment took place in two sites in London,
both offering the intervention and usual care, in order to explore challenges associated with
implementation of the intervention across two different set up of services. Both sites were run by a
partnership between a third sector organisation and the National Health Service (NHS), a common
funding model in the UK. The two sites had different integration levels; site 1 was fully integrated with a
single management and clinical governance system; site 2 had two parallel systems. Furthermore site 1
had been offering the intervention for several years as part of the standard treatment pathway, whereas in
site 2 the intervention had to be added to the clinical pathway.
Interventions
SPADe
The intervention provides structured group preparation (additional to usual care) with the aim of helping
participants (i) regain partial control over their drinking prior to detoxication and (ii) initiation of lifestyle
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changes for the individual and the immediate family environment. These changes are linked with
developing new coping skills and enhanced self-ecacy [22].
The six sessions are numbered and offered weekly in a given order. Stabilisation of the amount and
pattern of drinking is a common theme across all the sessions. To that effect each session can act as an
entry point (i.e. an open rolling programme group), despite the special theme covered in depth during the
second part of the session. Each session has two facilitators, lasts for one hour and is divided into three
parts:
• In the rst part (15 minutes) group rules are established, new members are introduced, aims of the
intervention. In-between sessions practice allocated in previous session where individual targets were
set are reviewed.
• The second part (30 minutes, main part) explores the following themes depending on session
number: 1 – Understanding habit, addiction and alcohol dependence; 2 – Stabilise and control your
drinking; 3 – Lifestyle changes for you and the people around you; 4 – Reduction of your drinking; 5
– Achieving abstinence; 6 – Relapse prevention strategies.
• In the third part (15 minutes), the group summarises the main learning points and agrees in-
between sessions practice and targets to be achieved before the next session. A group work folder
provided enabling notes and worksheets to be kept together.
The number of participants per group at any point is between two and eight. This is considered
appropriate for theory-based treatment groups, to (i) reach a balance between the educational and
treatment elements of the intervention, (ii) promote interactions between group members (group
therapeutic effect) and (iii) secure the facilitator’s attention to each member individually [23]. The
duration of 1 hour as suggested in Patient and Public Involvement meetings, reduces the risk of
withdrawal symptoms and help participants to maintain concentration.
Usual Care
Usual Care includes: planning for detoxication; detoxication delivery; and aftercare. Participants
entered detoxication at the rst available opportunity (expected to be within 4 weeks from presentation).
Whilst waiting for detoxication, they meet their keyworker (one-to-one) on 3–4 occasions to maintain
motivation and plan aftercare. Participants allocated to the intervention arm entered detoxication at the
rst available opportunity following completion of the intervention.
Detoxication was medically assisted in the community as an outpatient (both sites), or inpatient (only
for site 1), as clinically indicated. The choice depends on health risk factors and availability of social
support during detoxication [4]. Furthermore participants allocated to Intervention could achieve
abstinence by Guided Self-Detox. Guided Self-Detox refers to gradual reduction of drinking guided by the
group facilitator during the intervention period. As mentioned above aftercare (following detoxication)
included a relapse prevention group, a small number of individual key worker sessions, pharmacological
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interventions as appropriate peer support groups such as Self-Management and Recovery Training
(SMART) Recovery or Alcoholics Anonymous (AA) or more comprehensive aftercare group programme
either as an outpatient (both sites) or inpatient (only site 1).
Participants in both intervention and control groups received all the above elements of usual care
available in the recruiting service. At any time during the trial, change of clinical needs or risks were
monitored by the clinical team and participant’s treatment plan was modied accordingly, e.g. urgent
hospital admission. These incidents were monitored and reported as per standard ethical
recommendations for safety monitoring. Each participant’s care pathway was recorded and analysed for
variability within and between sites as part of the economic evaluation (see below), to ensure these are
equivalent across trial arms.
Outcomes
Feasibility measures
Feasibility outcomes were: (I) Recruitment and retention rates: monthly monitoring of the number of
alcohol dependent clients accessing services during the recruitment period of the study; how many meet
the eligibility criteria; and how many were invited and accepted into the study and retained in each group
for the full 12 months. (II) Compliance with treatment: number of SPADe sessions attended (for the
intervention arm) using the facilitator’s record of attendance. (III) Data collection and completeness:
attendance for assessments and completeness of instruments; loss to follow up and missing data for all
outcomes were analysed.
A variety of possible outcomes were used at different time points (3, 6 and 12 months following
randomisation), so the primary outcome for the main trial could be identied and sample size
calculations to be conducted, including: duration of continuous abstinence with no incidents of lapse or
relapse; percentage of days of abstinence (PDA) (both self-report using Time Line Follow Back method)
(TLFB) [24]; time to relapse (from stopping alcohol to rst day of alcohol use; also as dened by self-
report).
Secondary outcomes
Secondary outcomes were measured using validated instruments wherever possible at 3, 6 and 12
months:
1. 1. Severity of Alcohol Dependence Questionnaire (SADQ), a 20-item self-completion questionnaire,
scores range 0 to 60, (16 to 29 indicates moderate severity, above 30 severe dependence) [25].
2. 2. Alcohol Urge Questionnaire (AUQ), an eight-item self-completion questionnaire containing three
domains of drinking urges: desire for a drink; expectation of positive effect from drinking; inability to
avoid drinking [26].
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3. 3. Incentive Conict Task (ICT). This task assesses inherent conict in abstaining drinkers, between
the intention to abstain from drinking and the desire to drink, that may contribute to relapse [9].
Alcohol-dependent individuals, as they experience successive detoxications, become increasingly
impaired in performing the ICT [27].
4. 4. Euro-QoL (EQ-5D-5L); English version [28], which is a short questionnaire assessing general
healthcare used in economic evaluations for the calculation of Quality Adjusted Life Years.
5. 5. Self-reported participation in aftercare activities, using a specically developed log, measuring
type and frequency of activity attended, during the period prior the follow up interview.
Process evaluation – treatment delity
Observation of twenty ve percent of the intervention sessions, offered across both recruitment sites,
during the whole duration of the studywas planned using the Yale Adherence and Competence Scale
(YACS II) (2005) [29]. Furthermore, 10% of the sessions was planned to be rated by an additional
independent rater using YACS II. Group facilitators were asked to complete a self-assessment form
following each session to reect on their delity to the intervention manual.
Audio recording and rating of twenty ve percent of the key-working sessions offered to the usual care
group was plannedin order to assess possible contamination between the study arms, using a
specically developed form based on YACS II items and the main objectives of the SPADe group
intervention with low score indicating no presence of specic CBT content and no contamination.
Sample Size
No formal calculation is required for a feasibility study since measuring effectiveness is not a key
objective. The sample size of 50 was considered appropriate for assessing key objectives related to
recruitment, retention, randomisation, data capture, performance of outcome measures and acceptability.
Randomization And Masking
Once consented, participants were randomised using a third-party web-based randomisation system
which ensured concealed allocation. Participants were stratied according to number of previous
detoxications (> 2 vs  2) and site. Randomisation had a random block size (2–4). Research Assistants
(RAs) were blind to the randomisation of the opposite study site. It was planned to for them to conduct
the follow-up interviews of the opposite site. This initial plan for cross site follow up was abandoned
early during the 3 months follow up period as it was proven administratively challenging and was
considered a barrier for successful follow up efforts.
Statistical And Health Economic Analysis
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The main analysis was planned to be based on the intention-to-treat principle considering all randomised
clients according to the arm they were allocated.
The feasibility outcomes were summarised using descriptive statistics where appropriate. The potential
primary and secondary outcomes were summarised by arm, as well as completion rates estimated for
each outcome measure. Duration of continuous abstinence, as measured from randomisation, and the
time to relapse, as measured from the end of the detoxication wereanalysed using a Kaplan-Meier curve
and log-rank test. The percentage of Days of Abstinence (PDA) were analysed using a regression model.
Formal hypothesis tests and condence intervals were conducted although due to the nature of this trial
they were treated cautiously and the main focus was on the completion rate of outcomes, and the
estimation of parameters required for a sample size calculation for the main trial.
Economic evaluation in the feasibility study tested the collection of data on costs and outcomes that
would be required in any future denitive trial assessing the cost effectiveness of the SPADe intervention.
Clinic contacts with key workers and doctors for delivering the intervention and usual care were obtained
retrospectively from clinic records by research assistants. To assess potential service use offsets, data on
other service utilisation by participants was gathered by self report using the Client Service Receipt
Inventory. The CSRI was administered to participants by researchers in the clinic at 3, 6 and 12 months.
The questionnaire covers all forms of health and social care, and includes contacts with the police and
justice services [30].
Qualitative Interviews
A purposive sample of participants across both trial groups and sites (approximately 20) were planned to
be interviewed at three months to establish experiences of randomisation, recruitment and initial trial
procedures (wave 1) and follow up interviews were planned to take place at 9 months (completion of the
study, wave 2) to give specic feedback on retention issues and treatment conditions. Due to diculties
interviewing participants on two time points, interviews were conducted at any time between 6 and 9
months since recruitment into the study. A selected sample of staff involved with the intervention (both
directly and in-directly) were interviewed on study completion.
Results
Demographics
We recruited 48 out of 50 alcohol dependent individuals, aged 18 or over who had a desire to stop
drinking. Table1 shows the baseline data for all 48 randomised participants. Overall, whilst the two
groups were reasonably equivalent in terms of mean age, ethnicity, years of education and key variables
such as baseline SADQ, there were also important differences in sex and living arrangements with more
males and single people in the intervention group. However, this is not unexpected given the size of the
groups. Overall, the participants had an average age of 46.4years (range: 31 to 63), 28 (58%) were male
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and the had previously undertaken and median of 2 previous detoxications (range: 0 to 24). These
demographics are similar to the population in treatment
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Table 1
Baseline characteristics of randomised participants.
Usual Care (n = 23) Intervention (n = 25)
Age (years), mean (SD) 46.70 (9.82) 46.16 (10.94)
Gender, n(%)
Female 13 (57%) 7 (28%)
Male 10 (43%) 18 (72%)
Ethnicity, n(%)
African 1 (4%) 0 (0%)
Any other Black background 1 (4%) 1 (4%)
Any other ethnic group 0 (0%) 1 (4%)
Any other white background 3 (13%) 1 (4%)
British 12 (52%) 14 (56%)
Carribbean 0 (0%) 1 (4%)
Indian 5 (22%) 3 (12%)
Irish 1 (4%) 3 (12%)
Pakistani 0 (0%) 1 (4%)
Migrant, n(%) 11 (48%) 9 (36%)
Years of education, mean (SD) 11.57 (2.09) 11.88 (2.39)
Highest qualication, n(%)
A Level / NVQ 2 (9%) 7 (28%)
Diploma / BTEC 2 (9%) 0 (0%)
No qualication 4 (17%) 3 (12%)
O level / GCSE 11 (48%) 9 (36%)
Other (please specify) 1 (4%) 0 (0%)
University Degree 3 (13%) 6 (24%)
Employment status, n(%)
Full time 4 (17%) 3 (12%)
Part time 2 (9%) 3 (12%)
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Usual Care (n = 23) Intervention (n = 25)
Sick leave > 4 weeks 4 (17%) 2 (8%)
Unemployed 13 (57%) 17 (68%)
Relationship status, n(%)
Divorced 2 (9%) 3 (12%)
In a relationship but not living
together 3 (13%) 4 (16%)
Living together 1 (4%) 1 (4%)
Married 6 (26%) 1 (4%)
Separated 1 (4%) 1 (4%)
Single 9 (39%) 15 (60%)
Widowed 1 (4%) 0 (0%)
Family history of alcohol
problems, n(%) 12 (52%) 12 (48%)
Previous detoxication1,
median (IQR)
 
Total number 2 (1, 3) 1 (1, 5)
Inpatient alcohol unit 0 (0, 0) 0 (0, 1)
Acute hospital 0 (0, 0) 0 (0, 0)
Community or outpatient 0 (0, 1) 0 (0, 0)
Stopping without medication 1 (0, 2) 1 (0, 3)
Current smoker, n(%) 14 (61%) 20 (80%)
Used illicit drugs, n(%) 6 (26%) 8 (32%)
Mental health condition, n(%) 14 (61%) 13 (52%)
Current medication211 (48%) 11 (44%)
Psychological therapy in
previous 6 months, n(%) 3 (13%) 3 (12%)
SADQ, mean (SD) 34.61 (12.93) 33.59 (10.45)
SADQ Group
0–29 8 (35%) 8 (36%)
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Usual Care (n = 23) Intervention (n = 25)
30 + 15 (65%) 14 (64%)
Alcohol Urge Questionnaire,
mean (SD) 35.30 (17.04) 37.62 (14.19)
Feasibility outcomes
Recruitment
We were able to recruit 48/50 participants during a period of 9 months (September 2017-May 2018).
Thirty-three participants were recruited from site 1 and 15 from site 2. The main reasons for declining
participation included not wishing to be abstinent and inability to commit to group work. Recruitment was
easier when the research assistants were on site, which was supported by the qualitative interviews of
staff (see section below).
Retention
Retention in the trial was overall 75%, 80% (n = 20) for the intervention group and 69% (n = 16) for usual
care. The retention rate indicates strong acceptability in the study population.
Follow up
Overall the follow up rate was 65% (n = 31) at three months, 50% (n = 24) at six months and 63% (n = 30)
at 12 months, with more follow ups taking place over the phone. The follow up rate at 3 months was 74%
(n = 17) for usual care and 56% (n = 14) for the intervention. At 6 months it was 52% (n = 12) for usual
care and 48% (n = 12) for the intervention. Finally at 12 months it was 61% (n = 14) for usual care and
64% (n = 16) for the intervention. (Fig.1)
Intervention sessions attended
Treatment compliance, dened as attending 6 sessions over 12 weeks, was overall 44% with 47% (8/17)
and 37.5% (3/8) for the rst and second site respectively, which is considered acceptable for population
attending addiction services [13].
Data completeness
Completeness of data outcomes was varied (29% as lowest for Alcohol Urge Questionnaire at 6 months
to 74% for days of abstinence at 3 months). Completeness of primary outcome (PDA) was 65%, 50% and
63% at 3, 6 and 12 months follow up respectively.
Completion of the Incentive Conict Task (ICT) was compromised with only 13 tests completed at 3
months and even less at all 3 follow up points. This was direct result of the need for most participants to
be follow up over telephone and not face to face as initially planned.
Page 15/25
Table 2
Feasibility outcomes
Outcome Control (n = 23) Intervention (n = 25) Overall (n = 48)
Recruitment rate,
number per month
(95% CI)
6 (4.42,7.96)
Trial retention rate 16 (69.6%) 20 (80.0%) 36 (75.0%)
Compliance   
Site 1 8 / 17 (47.0%)
Site 2 3 / 8 (37.5%)
Completeness
Time line
(Days of abstinence)

3 Months 17 (74%) 14 (56%) 31 (65%)
6 Months 12 (52%) 12 (48%) 24 (50%)
12 Months 14 (61%) 16 (64%) 30 (63%)
SADQ   
3 Months 15 (65%) 14 (56%) 29 (60%)
6 Months 7 (30%) 8 (32%) 15 (31%)
12 Months 12 (53%) 13 (52%) 25 (52%)
Alcohol Urge
3 Months 15 (65%) 13 (52%) 28 (58%)
6 Months 7 (30%) 7 (28%) 14 (29%)
12 Months 11 (48%) 11 (44%) 22 (46%)
Progression criteria to a full RCT were agreed in advance and included study retention, treatment
compliance and data completion. As shown in Table 3, retention was excellent and no change is required.
Regarding treatment compliance minor changes are required, whereas regarding data completion for
primary outcome major changes are required before proceeding to a full trial.
Page 16/25
Table 3
Study progression criteria
Proceed Proceed with changes Do not proceed
without major changes
Compliance with the
intervention >=60% 40–59% < 40%
Retention of
participants in trial >=75% 50–74% < 50%
Completion of primary
outcome data in
participants not lost-
to-followup
>=90% 80–89% < 80%
Primary Outcomes
The intervention had more days abstinent in the previous 90 days at the 12 months (54.5) versus usual
care (41.5). Seven participants of the intervention and 5 of the usual care group restarted drinking at
some point during the follow up period.
Secondary outcomes
Severity of dependence (SADQ scores) were higher, time to relapse shorter and urges (Alcohol Urge
Questionnaire scores) higher for the intervention group at all follow up points.
Equal percentages (52%) from each arm were detoxed (including guided self-detox). This is lower than
anticipated, possibly due to generic challenges that services face.
Health economics evaluation
Of the total of 48 participants, 39 were included in the health economic analysis (19 intervention and 20
usual care). Of the nine excluded, one had crossed groups and the clinic records for eight in one site were
missing due to a facility relocation. Clinic data were not complete for many of the remaining 39
participants with more items missing in the usual care than intervention group. Approximately 50% of
participants in both groups provided 12 month follow up questionnaire data (service use and EQ-5D).
These levels of missing data were considered too high to provide accurate estimates of costs or changes
in health related quality of life. Two key workers delivered each session of the intervention at a cost
(2018) of £102 per session (£17 per participant per session, based on six per group, and NHS unit costs
[31].
Process evaluation-treatment delity
At least one of each of six group sessions were observed and scored for compliance with the manual, by
the Chief Investigator (CI) and an independent rater, using YACS II (2005). Furthermore group facilitators
were interviewed by the chief investigator following end of intervention provision period for the study.
Tape recording of key working sessions offered as part of usual care was done in site 1 only. Nine 9
Page 17/25
sessions assessed in total, with at least one of each of three planned sessions and at least one per
keyworker, using a specically developed tool (see above). In the second site keyworkers refused to be
taped. To that effect medical notes were reviewed by CI and content of session was scored using the
same assessment tool. Scores suggested no contamination of key working session with content from the
intervention in site 1. In site 2 though, 3/7 participants allocated to usual care, have received additional
sessions of psychological work beyond Motivational Interviewing, either by their keyworker or a
psychologist. .
Qualitative interviews
Fourteen participants were interviewed from both sites. Five of those were interviewed twice (between 3, 6
and 12 months) as per the original protocol, providing in total 19 interviews. Overall the qualitative data
was generally positive and supportive of the study. With a few exceptions, participants understood the
purpose of the study and were willing to be randomised. It was noteworthy that there was some
confusion regarding group allocation. This suggests that simply ‘being in the study’ had a positive
benet. Also of note was the positive feedback for the preparation groups (intervention). However the
interviews gleaned very little detailed data on CBT specic elements of the group intervention. Instead,
participants had generally positive feedback that seemed to be related to a generalised group effect
(being part of a group, sharing experiences, and learning from others). Most people found this benecial,
with only a few exceptions (notably those with diagnosed mental health conditions who found group
participation dicult).
Two staff members were interviewed (one from each site) following the end of the study. Staff were
generally supportive of the intervention, however staff acceptability of both content and structure was key
in consistent facilitation of the intervention. Staff were initially hesitant to use novel pre habilitation
strategies until they had seen results for themselves and then understood how it was useful to
participants. There were some practical issues raised – availability of rooms and room set up as being
important to the running of the groups. There was a lot of discussion about retendering and outcome
measures for joint service providers. These discussions initially impeded smooth service running and
group facilitation until it was evident that the intervention facilitated outcome measures for the service
providers. This is an important context for understanding diculties with implementing the group
intervention.
Discussion
We report here the results of a feasibility study on the addition of structured preparation before alcohol
detoxication to usual care against usual care only. The effect of adding some psychological intervention
during detoxication have been investigated before [32]. This study investigates the feasibility of
enhancing further the psychological work offered before detoxication within the overall concept of pre-
habilitation, to complement the existing rehabilitation treatment approach.
Page 18/25
We were able to recruit appropriate participants (moderate to severe dependence on alcohol) with a rate
of 6 recruits per month. The sample demographic characteristics were similar to those of the population
in treatment [33]. Randomisation was successful with the exception of more males and single people
having been allocated to the intervention arm, however, neither were considered to be important
confounders likely to results of this feasibility trial. Nevertheless, stratication based on gender and living
arrangements will be considered for the future trial.
The retention rate was very good for this type of population. Similarly follow up rates at 12 months for
primary outcome were also acceptable. Low follow up rates were observed at 6 months which coincided
with the immediate period prior and post re-tendering in the highest recruiting site (site 1). Interview over
telephone was the best follow up strategy but compromised the ability to collect data for ICT, CSRI and
other questionnaires, indicating the importance of using brief tools rather than self-completion
questionnaires. A mixed method of CSRI and clinical notes review should be used for health evaluation.
There were also technical diculties with the operation of ICT. Despite the above challenges this is the
rst time that ICT is used with persons while they are still drinking (23 participants at baseline), which
provides valuable data on the effect of alcohol in decision making (see Table 2). These results will be
reported separately. Data completion though for the primary outcome was lower than expected
suggesting major changes required. A longer recruitment period with full time RAs positioned in each
recruiting site is considered more effective rather than seeking larger numbers of recruiting sites with
either part time RAs or full time RAs recruiting for shorter recruitment periods.
To allow for better monitoring of study participants RAs were only blind to randomisation of the opposite
site. The original plan was for RAs to complete follow ups of the opposite site hence to be blind to
allocation. This was proven over ambitious for a trial with this population. The administrative
arrangements and the resulted limited exibility of RAs due to travel arrangements compromised the
initial follow ups. Blinding for psychological interventions is dicult with this population [4].
Compliance with the intervention although acceptable, has indicated that changes are required for the full
trial. We consider that recruitment and randomisation at the rst point of contact with the service has
increased the risk of early dropping out of treatment as a whole, compromising treatment compliance.
Furthermore in the current study two clients, with long histories of poor treatment retention and early drop
outs were allocated to the intervention arm. In a future RCT, we will randomise clients at a later point,
once they are retained for a brief period (usual practice 4 weeks). In a future RCT, the intervention will be
better standardised with expectation that participants attend consecutive weekly sessions, within a
maximum period of 12 weeks, with missed sessions offered by one of the facilitators as individual brief
sessions and more enhanced cooperation between key workers and group facilitators.
The strategy used to assess delity to the intervention manual was adequate. It seems that the training,
supervision and support provided to group facilitators were adequate for the feasibility trial. For the future
trial this task should be allocated to local supervisors per recruitment sites for more hands-on support.
Page 19/25
This is considered even more important for the keyworkers to reduce even further any contamination
between the intervention and usual care.
There was a major difference between the two sites on the procedures for access to inpatient
detoxication. In site 1 the decision and the budget was controlled by the local team whereas in site 2 the
decision and budget allocated involved commissioners and specic steps had to be followed (which did
not allow randomisation). This meant that only participants requesting outpatient detoxication were
entered into the study in site 2. This number was anticipated and proven to be low. The rest of the
procedures across sites were standardised during phase 1.
The low rate of participants receiving detoxication for both arms, could be an indicator of limited
progression of clients through treatment stages, which might indicate major challenges that services face
in their efforts to deliver treatment in a timely and structured way. Generic factors such as tendering of
services, limited resources and high turnover of staff, could compromise the capacity of treatment
services and systems to host clinical research and could also compromise the standarised delivery of
both intervention and usual care. These factors have been discussed widely both in the past and more
recently in the UK [32]. In a future trial the ongoing support to group facilitators and the monitoring of
usual care provision should be augmented, given the challenging clinical reality.
Conclusions
Psychological interventions with people who are dependent on alcohol and who are actively drinking at
the time of the intervention have been regarded challenging. Furthermore limited work has been done so
far on their effectiveness and cost-effectiveness. The results of the feasibility trial indicate that despite
the challenges described above, with the appropriate modications, a full multi centred trial would be
possible to test the effectiveness and cost-effectiveness of a pre- habilitation SPADe group intervention
against usual care.
Declarations
Ethics approval and consent to participate
The study was approved by the Health Research Authority (HRA) Research Ethics Committee (REC) (IRAS
ID:213086) for all participating centres. All study personnel will comply with the MCA 2005 (33) and
published research governance guidelines. We anticipate that all participants will have capacity to
consent and sucient verbal communication skills to take part in the treatment and in the qualitative
interview. Informed written consent will be obtained from all participants. As this is a non-invasive
intervention, we do not anticipate any adverse events, but we will follow safety reporting guidance issued
by the National Research Ethics Service (UK) for studies except clinical trials of investigational medicinal
products. The study has been approved by the Research and Development (R&D) departments of the
relevant recruiting sites.
Page 20/25
Consent for publication
Not applicable
Availability of data and materials
The datasets generated and/or analysed during the current study are available from the corresponding
author on reasonable request.
Competing interests
The authors declare that they have no competing interests.
Funding
This study is supported by the UK National Institute for Health Research (NIHR) under its Research for
Patient Benet (RfPB) Programme (Grant Reference Number PB-PG-0815-20014). The funder of the study
had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The
authors had full access to all the data in the study and had nal responsibility for the decision to submit
for publication.
Authors’ contributions
CK had overall management of the research project, developed the intervention manual,supervised the
therapists and contributed to all outputs such as papers in conference and journals. He has contributed
to the writing of the current paper.
BH is a Research assistant on the project, conducted the assessments and interviews with participants
and carers, has contributed to the paper content and its preparation for submission.
HG is the lead for the health economics part of the project and oversaw the analysis of those data.
CN is the lead for the qualitative study. She trained the research assistants for the qualitative interviews
and supervised the analysis of the data.
VM was the overall project manager. She was responsible for the coordination of study recruitment
across sites, the supervision and support of the research assistants.
AC is the project statistician. He was responsible for, all statistical aspects including randomisation and
analysis of quantitative data.
Page 21/25
RH, ALH contributed into the methodological aspects of the project and participated in data analysis and
dissemination of the ndings.
BP was responsible for coordination of recruitment from one of the participating services.
TD was responsible for the training and appropriate use of the ICT.
Acknowledgements
We thank the service users’ representatives participating in this study. We thank the study sponsor Surrey
and Borders Partnership NHS Foundation Trust, the Camden and Islington NHS Foundation Trust,
collaborating researcher assistant and therapists, and members of the Steering Committees.
This paper presents independent research funded by the National Institute for Health Research (NIHR)
under its Research for Patient Benet(RfPB) Programme (Grant Reference Number PB-PG-0815-20014).
The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department
of Health and Social Care.
Authors’ information
CK is a Consultant Psychiatrist in Addictions; his PhD is on psychological interventions in substance
misuse. BH is a research assistant. HG is a Professor of Health Economics. CN is a Senior Lecturer in
Mental Health and a Research fellow of the Society for the Study of Addiction. VM is a Research Fellow
and Senior Programme Co-ordinator. AC is a Senior Lecturer in Statistics. RH is Head of Leicester Medical
School and Professor of Public Health Medicine. ALH is a Professor in Psychiatry, Chair of Addiction
Biology and Consultant Psychiatrist in Addictions. BP is a Consultant Psychiatrist in Addictions. TD is a
Professor in Experimental Psychology.
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Figure 1
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1. Exercise of personal and collective efficacy in changing societies Albert Bandura 2. Life trajectories in changing societies Glen Elder 3. Developmental analysis of control beliefs August Flammer 4. Impact of family processes on self-efficacy Klaus A. Schneewind 5. Cross-cultural perspectives on self-efficacy beliefs Gabriele Oettingen 6. Self-efficacy in educational development Barry Zimmerman 7. Self-efficacy in career choice and development Gail Hackett 8. Self efficacy and health Ralf Schwarzer and Reinhard Fuchs 9. Self-efficacy and alcohol and drug abuse Alan Marlatt, John S. Baer and Lori A. Quigley.