Brown 1993.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 54 Length of follow‐up: 15 months Analysis: per‐protocol (6 dropouts in intervention arm, 8 dropouts in control arm at 15 months) |
|
| Participants | Location: USA Number of study centres and setting: patients recruited from 5 cardiac rehabilitation departments of medical centres and by newspaper advertisements CAD critieria: MI and/or coronary bypass surgery 4 to 24 months before study; diagnosis based on physician's report; prognosis of no worse than 3.3 based on the New York Heart Association criteria for moderately compromised cardiac status; stable cardiac status with no medical contraindications to increased physical activity according to their physician's report Depression criteria: new‐onset depression and/or anxiety on the SADS; scores of > 13 on the BDI or > 70 on the SCL 90‐R Other entry criteria: spouses, friends, or relative who was willing to participate; age between 43 and 75 years Exclusion criteria: unstable medical condition; chronic, severe depression and/or anxiety preceding the cardiac event; suicidal ideation; changes in county residence; unwillingness or inability to include a partner; pre‐existing psychiatric disorder Treatment N: 20 (45% female, mean age: 63.55 (SD: 7.43)) Control N: 20 (10% female, mean age: 57.65 (SD: 7.82)) Comparability of groups: significant baseline differences regarding age, religion, SCL 90‐R, BDI (with control being more distressed on SCL 90‐R and BDI) |
|
| Interventions | Treatment: behaviour therapy for participants and their partners by Lewinsohn (weekly 1‐hour sessions) in which participants should increase and intensify adaptive behaviours (pleasant activities, relaxation, cognitive restructuring, assertion/anger management, time management) and partners practise positive reinforcement of adaptive behaviours and ignore maladaptive behaviours Control: person‐centred therapy by Rogers (weekly 1‐hour sessions) Duration of treatment: 12 sessions (treatment and control) |
|
| Outcomes | Outcomes: depression symptoms (BDI) Other outcomes: SADS‐C, SCL 90‐R, Minnesota Multiphasic Personality Inventory‐168 (MMPI‐168), Pleasant Events Schedule (PES), Unpleasant Events Schedule (UES), Locke Wallace Marital Adjustment Test, Katz Adjustment Scale |
|
| Funding | Study supported in part by a grant from the American Heart Association. | |
| Notes | Study investigated effects of behaviour therapy of participants and their partners on depression and/or anxiety in comparison to person‐centred therapy. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Blinding of patients not stated Comment: therapists supervision provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: Regarding Schedule of Affective Disorders and Schizophrenia (SADS) "None of the therapists conducted the post‐treatment interviews." (p.203) Comment: All other outcomes patient self‐report |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Per‐protocol analysis and no drop‐out analysis (14 of 54 patients dropped‐out from baseline to 15‐month follow‐up). Missing data present |
| Selective reporting (reporting bias) | Unclear risk | Comment: Outcomes reported as stated in the methods section; no protocol or design paper available |
| Other bias | Unclear risk | Comment: significant baseline imbalance between groups in baseline depression (BDI) and age Comment: therapists rated and monitored for quality; no efforts regarding therapy quality mentioned; therapist quality analaysis provided |