Barth 2005.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 59 Length of follow‐up: No follow‐up Analysis: Per‐protocol (4 patients 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 Myocardial Infarction (MI), Coronary Artery Bypass Grafting (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), Unstable Angina Pectoris; diagnosis based on physician's report; time to randomisation unclear Depression criteria: Major depression, dysthymia and depressive adjustment disorder assessed in a 2‐stage procedure: 1) Hospital Depression and Anxiety Scale (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, individualized, 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; patients with severe depression were treated additionally with sertraline Control: Usual care Duration of treatment: 3 to 4 weeks during inpatient rehabilitation |
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| Outcomes | Review outcomes: Bech Rafaelsen Melancholia Scale (BRMS), Beck Depression Inventory (BDI) score, HADS depression score 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 (performance bias and detection bias) All outcomes | Low risk | Comment: Blinded interviewers for BRMS |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: Table 2 (p. 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 Comment: No protocol or design paper available |
| Other bias | Unclear risk | Comment: Possible performance bias with regard to manual adherence of therapists in treatment group, which remains unclear. Furthermore, 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. |