Nathan 1986.
Methods | RCT. | |
Participants | 7 females aged between 25 and 50 with a DSM‐III diagnosis of generalised anxiety disorder, with daily BZD use of over 6 months in USA. 3 participants in intervention group 1; 4 participants in intervention group 2. | |
Interventions | Intervention group 1: Intensive psychotherapy. Seen individually for 10‐minute sessions to simulate counselling and encouragement of traditional medical care. Individual psychoanalytical psychotherapy was offered, conducted for 10 weekly one hour sessions by two individuals; a board certified psychiatrist and a licensed psychiatric social worker Intervention group 2: Bio feedback assisted stress management. Seen individually for 10 weekly sessions by one of two licensed psychologists. Taped relaxation therapy twice daily at home. EMG and skin temperature biofeedback in the office. GSR‐II at home. Limited supportive stress management counselling. |
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Outcomes | Urine drug screens, Saliva drug screens, self‐reported reduction in BZD use, measure of anxiety. Measures were taken at baseline, 1 month, 3 months and 12 months. | |
Notes | Funding source: Not reported. Declaration of interest: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Blinding was not used. However, the objective outcomes were measured using urinalysis and saliva drug screens so this is unlikely to have been biased. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Subjective measures were not used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding was not used. However, the objective outcomes were measured using urinalysis and saliva drug screens so this is unlikely to have been biased. |
Blinding of outcome assessor (detection bias) subjective outcomes | Unclear risk | Subjective measures were not used. |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Of the seven patients who received treatment, only the four in stress management treatment were available for 1‐year follow up". |
Selective reporting (reporting bias) | Unclear risk | Outcomes not specified in methods and not clearly described. |