| Methods |
RCT to compare three conditions. Randomisation is stratified (severity of depression). Assessments on three occasions: baseline, 6 and 12 weeks. |
| Participants |
91 patients (aged 18‐65) with major depression (research criteria for major depression and Hamilton rating scale score 13 or more) recruited from 26 GPs in 15 practices . Therapists: 2 research GPs (and 1 psychiatrist). |
| Interventions |
T1 (n:30) = problem solving treatment (PST) (explanation rationale, emotional symptoms are caused by problems in living that can be dealt with; identification problems; stages of PST explained).
T2 (n:31) = amitriptyline (50 mg‐150 mg) and general support.
C (n:30) = placebo and general support.
All groups: 6 30‐60‐min sessions in 12 weeks.
Therapists received training in PST( theory, role playing, treating five patients under supervision) and drug administration. Supervision of therapists unknown. |
| Outcomes |
12 week follow‐up:
T1 superior to C on depression (BDI and Hamilton) and social functioning (SAS). No sign. difference on psychological symptoms (PSE).
No sign. differences between T1 and T2.
Recovered cases (Hamilton <8): T1=18/30, T2=16/31, C=8/30 (difference T1 and C significant). Patient satisfaction ("T is (very) helpful"): T1=28/30, T2=21/31. |
| Notes |
non‐compliance: T1=2/30, T2=6/31, C=18/30.
withdrawal (82 patients included in analysis): T1=1/29, T2=2/27, C=14/26.
no integrity check. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
