Hofmann 2006.
Methods | Design: Randomised, double‐blind, placebo controlled augmentation trial Study duration: 5 weeks Follow‐up: 1 month Country: USA |
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Participants | Sample size: 27 adult patients eligible and agreed to participate Recruitment: self‐referred from the community to one of three research clinics Inclusion criteria ‐ diagnostic classification criteria: DSM‐IV primary diagnosis of SAnD with significant public speaking anxiety Inclusion criteria ‐ rating scales: Anxiety Disorder Interview Schedule for Adults (ADIS‐IV) and self‐reported fear of public speaking Included disorders: SAnD and co‐morbid diagnoses Co‐morbidities: 11 individuals had at least 1 additional DSM‐IV Axis I diagnosis; 9 had an additional anxiety disorder and 4 had an additional mood disorder Gender: 70% male Mean age: 33.70 years (SD 10.02 years) Ethnicity: 59.3% White, 14.8% Asian, 11.1% Hispanic, 11.1% African American Pharmacotherapy during the study: Naturalistic prescribing allowed; 1 participant was taking a benzodiazepine, 9 participants were taking an antidepressant, 1 participant was taking a beta‐blocker, and 3 participants were taking stimulants |
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Interventions |
Therapists: Sessions were administered by therapists who were supervised and trained by 2 of the article authors |
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Outcomes | Withdrawals; anxiety: LSAS; adverse events | |
Notes | Funding from Industry: Unclear Medication funded by industry: Unclear Any authors work for industry: Unclear Study ID: NCT00515879 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 'Patients were randomised to either adjunctive DCS or pill placebo administered as a 50‐mg pill on each of 4 occasions.' Study was randomised but method of sequence generation not stated. However, since allocation concealment was adequate we assume that randomisation method was adequate |
Allocation concealment (selection bias) | Low risk | 'The random allocation sequence was generated by numbering containers with the medication. The sequence was generated prior to allocating participants and was concealed until the end of the study.' Matching d‐cycloserine or placebo was given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | 'All of the individuals involved inpatient care, evaluation, or study supervision were blind to group assignment until the end of the study.' |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 'All of the individuals involved inpatient care, evaluation, or study supervision were blind to group assignment until the end of the study.' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the 32 eligible participants, 5 had to be excluded from analysis for the following reasons: 4 patients withdrew after signing the consent form or after the initial treatment session, and 1 patient was excluded owing to a protocol violation. Twenty‐seven patients (12 who received exposure therapy plus DCS and 15 who received exposure therapy plus placebo) completed the 5‐session treatment. Twenty‐three patients (10 who received exposure therapy plus DCS and 13 who received exposure therapy plus placebo) completed the 1‐month follow‐up assessment. |
Selective reporting (reporting bias) | High risk | No information was provided on the following outcomes as per protocol ‐ Social Phobic Disorders Severity and Change Form, Quality of Life Enjoyment and Satisfaction Questionnaire, Range of Impaired Functioning Tool |
Other bias | Unclear risk | A large percentage of patients (11 patients, 40.7%) were receiving concomitant medications, which might have confounded the results |