Targ 1994.
Methods | Randomized controlled trial. Randomization method: not specified. Power: not specified. Analysis: not ITT. |
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Participants |
Country: USA. Setting: unknown. Recruitment: from local community with newspaper advertisements. Inclusion criteria: asymptomatic PLWH receiving AZT, meeting criteria (not specified) for major depression or adjustment disorder with depressed mood and score of ≥ 16 on HAM‐D. Failure of previous antidepressant regimens was not an exclusion criterion in this study. Exclusion criteria: none reported. Number randomized: 20. Number dropped out: 2. Age (mean): 33 years (range 26‐49 years). Gender: 100% men. Baseline HAM‐D score (mean): fluoxetine: 20.8 (SD 5.3); placebo: 19.7 (SD 4.0). CD4 T‐cell count (mean): fluoxetine: 330.2 cells/mm3 (SD 144.7); placebo: 494.5 cell/mm3 (SD 175.8). ART: all participants receiving AZT. Ethnicity: 84% white; 16% Latino. Socioeconomic details: mean 15.5 years of education. |
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Interventions |
Experimental arm: fluoxetine 20 mg daily. Comparison arm: placebo daily. Adjunctive treatment: structured group therapy including: relaxation techniques training; problem‐solving skills training; didactic presentations; open discussion. 3 psychotherapy groups of 6‐8 participants run by 4th year psychiatry residents. Standardized through weekly supervision. Duration: 12 weeks. |
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Outcomes |
Primary outcomes:
Secondary outcomes:
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Notes |
Date of study: unknown. Funding: none reported. Declaration on interest by authors: none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded to treatment assignment through use of placebo. Unknown if remaining personnel blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 (10%) participants lost to follow‐up, 1 in each group; unlikely to have a significant impact on results. |
Selective reporting (reporting bias) | Low risk | No evidence. Protocol not assessed. |
Other bias | Low risk | None noted. |