Barth 2005.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 59 Length of follow‐up: no follow‐up Analysis: per‐protocol (4 participants in the control group dropped out) |
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| Participants | Location: Germany Number of study centres and setting: 3 cardiac inpatient rehabilitation clinics CAD criteria: patients with MI, CABG, PTCA, unstable angina pectoris; diagnosis based on physician's report; time to randomisation unclear Depression criteria: MDD, dysthymia and depressive adjustment disorder assessed in a 2‐stage procedure: 1) HADS and 2) Structured Clinical Interview for DSM‐IV in all patients with a HADS score of 17 or higher Other entry criteria: none stated Exclusion criteria: poor general health, language and cognitive deficits, bipolar disorder, psychotherapy at residence, psychotic symptoms Treatment: 27 (18.5% female, mean age: 60.8 (SD: 11.1)) Control: 32 (28.1% female, mean age: 55.6 (SD: 10.1)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: brief, individualised, resource‐orientated psychotherapy (4 to 6 sessions of 50 minutes each) comprising patient education, motivation, goal setting, crisis management, modification of dysfunctional cognitions and behaviour, and written recommendations for further outpatient treatment; participants with severe depression were also treated with sertraline Control: usual care Duration of treatment: 3 to 4 weeks during inpatient rehabilitation |
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| Outcomes | Review outcomes: depression symptoms (Bech Rafaelsen Melancholia Scale, also BDI and HADS) Other outcomes: HADS anxiety score |
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| Funding | Ministry for Education and Research, Germany, Federal Insurance Authority, Baden‐Württemberg, Germany | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Randomisation carried out by methodology center (independent from study staff) |
| Allocation concealment (selection bias) | Low risk | Comment: By sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Participants and interventionists unmasked. Blinding to psychopharmacological interventions unclear. Possible performance bias with regard to manual adherence of therapists in treatment group, which remains unclear |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: primary outcome (BRMS) interviewers blinded to allocation. All other outcomes patient self‐report |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: Table 2 (pg. 6/7): "Only patients with data at both assessments were included in the analysis." |
| Selective reporting (reporting bias) | Unclear risk | Comment: Outcomes as stated in methods section. No protocol or design paper available |
| Other bias | Unclear risk | Comment: In inpatient studies, therapists and clinic staff are not blind to the patients' allocation, which might impact the inpatient treatment of the intervention and the control group |