Article

Strategy for treating selective serotonin reuptake inhibitor-resistant social anxiety disorder in the clinical setting: a randomised controlled trial protocol of cognitive behavioural therapy in combination with conventional treatment

Department of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine, Chiba, Japan.
BMJ Open (Impact Factor: 2.06). 01/2013; 3(2). DOI: 10.1136/bmjopen-2012-002242
Source: PubMed

ABSTRACT Introduction: Pharmacotherapy and cognitive behavioural therapy (CBT) are consistently effective as first-line treatments for social anxiety disorders (SADs). Nevertheless, pharmacotherapy is often the first choice in clinical practice. In many countries, the first line of pharmacotherapy involves the administration of a selective serotonin reuptake inhibitor (SSRI). Although a significant proportion of patients with SAD fail to respond to the initial SSRI administration, there is no standard approach to the management of SSRI-resistant SAD. This paper describes the study protocol for a randomised controlled trial to evaluate the clinical effectiveness of CBT as a next-step strategy, concomitant with conventional treatment, for patients with SSRI-resistant SAD. Methods and analysis: This Prospective Randomized Open Blinded End-point study is designed with two parallel groups, with dynamic allocation at the individual level. The interventions for the two groups are conventional treatment, alone, and CBT combined with conventional treatment, for 16 weeks. The primary end-point of SAD severity will be assessed by an independent assessor using the Liebowitz Social Anxiety Scale, and secondary end-points include severity of other social anxieties, depressive severity and functional impairment. All measures will be assessed at weeks 0 (baseline), 8 (halfway point) and 16 (postintervention) and the outcomes will be analysed based on the intent-to-treat. Statistical analyses are planned for the study design stage so that field materials can be appropriately designed. Ethics and dissemination: This study will be conducted at the academic outpatient clinic of Chiba University Hospital. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with the recommendations of CONSORT.

Full-text

Available from: Naoki Yoshinaga, Apr 17, 2015
0 Followers
 · 
198 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Cognitive-behavioral therapy (CBT) is frequently used for various adult anxiety disorders, but there has been no systematic review of the efficacy of CBT in randomized placebo-controlled trials. The present study meta-analytically reviewed the efficacy of CBT versus placebo for adult anxiety disorders. We conducted a computerized search for treatment outcome studies of anxiety disorders from the first available date to March 1, 2007. We searched MEDLINE, PsycINFO, PubMed, Scopus, the Institute of Scientific Information, and Dissertation Abstracts International for the following terms: random*, cognitive behavior*therap*, cognitive therap*, behavior*therap*, GAD, generalized anxiety disorder, OCD, obsessive compulsive disorder, social phobia, social anxiety disorder, specific phobia, simple phobia, PTSD, post-traumatic stress disorder, and acute stress disorder. Furthermore, we examined reference lists from identified articles and asked international experts to identify eligible studies. We included studies that randomly assigned adult patients between ages 18 and 65 years meeting DSM-III-R or DSM-IV criteria for an anxiety disorder to either CBT or placebo. Of 1165 studies that were initially identified, 27 met all inclusion criteria. The 2 authors independently identified the eligible studies and selected for each study the continuous measures of anxiety severity. Dichotomous measures reflecting treatment response and continuous measures of depression severity were also collected. Data were extracted separately for completer (25 studies for continuous measures and 21 studies for response rates) and intent-to-treat (ITT) analyses (6 studies for continuous measures and 8 studies for response rates). There were no significant differences in attrition rates between CBT and placebo. Random-effects models of completer samples yielded a pooled effect size (Hedges' g) of 0.73 (95% CI = 0.88 to 1.65) for continuous anxiety severity measures and 0.45 (95% CI = 0.25 to 0.65) for depressive symptom severity measures. The pooled odds ratio for completer treatment response rates was 4.06 (95% CI = 2.78 to 5.92). The strongest effect sizes were observed in obsessive-compulsive disorder and acute stress disorder, and the weakest effect size was found in panic disorder. The advantage of CBT over placebo did not depend on placebo modality, number of sessions, or study year. Our review of randomized placebo-controlled trials indicates that CBT is efficacious for adult anxiety disorders. There is, however, considerable room for improvement. Also, more studies need to include ITT analyses in the future.
    The Journal of Clinical Psychiatry 05/2008; 69(4):621-32. DOI:10.4088/JCP.v69n0415 · 5.14 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Clonazepam and placebo were administered in a double-blind pilot study to 75 outpatients with social phobia. The mean maximum dose of clonazepam was 2.4 mg/day at endpoint (range, 0.5 to 3 mg). Treatment was continued for up to 10 weeks. The results of an intent-to-treat analysis indicated superior effects of clonazepam on most measures. Response rates for clonazepam and placebo were 78.3 and 20.0%. Drug effects were apparent on performance and generalized social anxiety, on fear and phobic avoidance, on interpersonal sensitivity, on fears of negative evaluation, and on disability measures. Significant differences were evident by week 1, 2, or 6, depending upon the rating scale used. Clonazepam was well tolerated in general, although unsteadiness and dizziness were more severe and persistent than was the case for placebo subjects.
    Journal of Clinical Psychopharmacology 01/1994; 13(6):423-8. DOI:10.1097/00004714-199312000-00008 · 3.76 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To compare the effects of an intensive group cognitive treatment (IGCT) to individual cognitive therapy (ICT) and treatment as usual (TAU) in social phobia (DSM-IV). Hundred patients were randomized to: IGCT involving 16 group sessions spread over three weeks; ICT involving 16 shorter weekly sessions in 4 months and; TAU involving an indicated selective serotonin reuptake inhibitor (SSRI) with therapy sessions as required for 1 year. The main outcome measure was a Social Phobia Composite that combined several standardized self-report measures. Diagnostic assessment was repeated at 1-year follow-up. Significant improvements were observed with all treatments. ICT was superior to IGCT and TAU, which did not differ in overall effectiveness. The study confirms and extends previously reported findings that ICT is more effective than group cognitive treatment and treatment with SSRIs. IGCT lasts only 3 weeks, and is as effective as more protracted TAU.
    Acta Psychiatrica Scandinavica 03/2007; 115(2):142-54. DOI:10.1111/j.1600-0447.2006.00839.x · 5.55 Impact Factor