Brown 1993.
| Methods | RCT design: 2‐arm parallel group trial Total N randomised: 54 Length of follow‐up: 15 months Analysis: per‐protocol, 14 drop‐outs at 15 months |
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| Participants | Location: USA Number of study centres and setting: Patients recruited from 5 cardiac rehabilitation departments of medical centres and by newspaper advertisements CAD diagnosis: Myocardial infarction 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 criteria of the New York Heart Association for moderately compromised cardiac status; stable cardiac status with no medical contraindications to increased physical activity according to their physician´s report Depression diagnosis: New‐onset depression and/or anxiety on the Schedule of Affective Disorders and Schizophrenia (SADS); scores of >13 on the Beck Depression Inventory (BDI) or >70 on the Symptom Checklist 90‐Revised (SCL 90‐R) Other entry criteria: Spouses, friends, or relative who were 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, preexisting 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) |
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| Interventions | Treatment: Behavior therapy for patients and their partners by Lewinsohn (weekly 1‐hour sessions), in which patients should increase and intensify adaptive behaviors (pleasant activities, relaxation, cognitive restructuring, assertion/anger management, time management) and partners practice positive reinforcement of adaptive behaviors and ignored maladaptive behaviors Control: Person‐centered therapy by Rogers (weekly 1‐hour sessions) Duration of treatment: 12 sessions (treatment and control) |
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| Outcomes | Outcomes: BDI score 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 |
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| Funding | Study supported in part by a grant from the American Heart Association | |
| Notes | Study investigated effects of behavior therapy of patients and their partners on depression and/or anxiety in comparison to person‐centered 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 (performance bias and detection bias) All outcomes | Unclear risk | Comment: Blinding of patients not stated 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) Comment: Missing data present |
| Selective reporting (reporting bias) | Unclear risk | Comment: Outcomes reported as stated in the methods section Comment: No protocol or design paper available |
| Other bias | High risk | Comment: No efforts regarding therapy quality mentioned Comment: Significant baseline imbalance |