Hofmann 2013.
| Methods | Design: Randomised double‐blind placebo controlled trial Study duration: 12 weeks Follow‐up: 6 months Country: USA |
|
| Participants | Sample size: 169 participants were randomised Recruitment: Participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University, Massachusetts General Hospital, and Southern Methodist University) from other area clinical facilities and programs, and through advertisements Inclusion criteria ‐ diagnostic classification criteria: DSM‐IV diagnosis of generalized social anxiety disorder Inclusion criteria ‐ rating scales: score > 60 on the Liebowitz Social Anxiety Scale Included disorders: SAnD Co‐morbidities: entry of patients with other mood or anxiety disorders was permitted if the social anxiety disorder was judged to be the predominant disorder Gender: DCS group 64.4% male; placebo group 48.8% male Mean age: DCS group 34.6 years; placebo group 30.5 years Ethnicity: DCS group 70.1% White, 9.2% African‐American, 15% Asian, 5.7% other, 10.3 Hispanic or Latino; placebo group 74.4% White, 9.8% African‐American, 8.5% Asian, 7.3% other, 11.0% Hispanic or Latino Pharmacotherapy during the study: Naturalistic prescribing not allowed |
|
| Interventions |
Therapists: All therapists were trained and supervised by senior clinicians and participated in weekly cross‐site supervision |
|
| Outcomes | Response; withdrawals; remission; anxiety: LSAS; adverse events | |
| Notes | Funding from industry: No, supported by NIMH grant Medication supplied by industry: Not reported Any author work for industry: Dr Hofmann has received royalties from multiple publishers, including Routledge, the publisher of the CBT manual used in the study. Dr Otto has also received royalties from Routledge. Dr Pollack has served as a consultant for Bristol‐Myers Squib, Euthymics, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Medavante, and Targia Pharmaceuticals and has equity in Medavante, Mendsante, Mindsite and Targia Pharmaceuticals Study ID: NCT00633984 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Assignment to treatment condition was determined by a computer‐generated allocation schedule with stratification by baseline severity of social anxiety disorder." |
| Allocation concealment (selection bias) | Unclear risk | Details of allocation concealment method not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All capsules were identical in appearance to maintain the blind." " patients were asked to indicate whether they believed the pill contained d‐cycloserine or placebo or whether they were unable to guess. Approximately one‐third to one‐half of all patients (30.9%–46.2%, depending on group and session) in both conditions reported that they were unable to guess their treatment condition (all chi‐square tests, n.s.). Among patients who guessed either of the two drug conditions, those who received d‐cycloserine did not differ significantly from those who received placebo in their guess that they received d‐cycloserine, in any of the sessions". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The blinded assessments were conducted by a master’s‐level or doctoral‐level clinician trained in these assessments." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Attrition rates during the 12‐week treatment phase were low and did not differ significantly between groups (10.3% for the DCS group and 15.9% for the placebo group)." "Attrition was low during the follow‐up phase (11.5% and 11.)% for the DCS and placebo groups, respectively)." |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in the protocol were reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |