SPIRR‐CAD 2011.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 570 Length of follow‐up: 6 months Analysis: ITT (last‐observation‐carried‐forward) and per‐protocol analysis (24 did not receive intervention; 174 dropouts in intervention group, 90 dropouts in usual care group) |
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| Participants | Location: Germany Number of study centres and setting: multicentre; 10 tertiary care centres in Germany CAD criteria: documented CAD with recent coronary angiograms Depression criteria: HADS Depression > 7 Other entry criteria: none Exclusion criteria: inability to speak German; severe heart failure (NYHA class IV); scheduled cardiac surgery within the next 3 months; severe depressive episodes according to Structured Clinical Interview for DSM‐IV (SCID) or other severe life‐threatening physical or mental illness Treatment N: 285 (21.4% female, mean age 59.1 (SD: 9.8)) Control N: 285 (20.7% female, mean age 59.3 (SD: 9.3)) Comparability of groups: no baseline‐differences in sociodemographic, clinical, and psychological data |
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| Interventions | Treatment: stepwise, fully manualised individual and group psychotherapy in addition to usual care by primary physicians or cardiologist, or both. All participants were offered 3 individual supportive‐expressive psychotherapy sessions. Participants' partners were invited for the third session. All participants were reassessed with the HADS after the third session (4 to 6 weeks after inclusion), and those who were still depressed were offered 25 90‐minute sessions of group psychotherapy in closed groups of 6 to 10 participants for approximately 10 months, usually starting 3 to 6 months after randomisation. Control: usual care by primary physicians and/or cardiologist and 1 manualised individual information session, 30 to 45 minutes delivered by trained staff (content of information session: healthy behaviours and psychosocial factors in CAD) Duration of treatment: 18 months |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D, also HADS), depression remission (HADS ≤ 7), all‐cause mortality, cardiovascular mortality Other outcomes: type D personality |
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| Funding | German Research Foundation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Online randomization service, ALEA, 1:1 ratio |
| Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "blinding of the intervention to patients and therapists was not possible" Comment: control participants received information session |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: Outcome assessments were performed by patients self report (HADS) and face‐to‐face interviews (HAMD, SCID) with trained raters who where masked regarding patients treatment assignment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: analyses ITT with and without imputation LOC method (per‐protocol also reported, not extracted) Comment: imbalance in loss to follow‐up between groups (174 drop‐outs in intervention group (61.3%), 90 drop‐outs in usual care group (31.7%)) |
| Selective reporting (reporting bias) | Unclear risk | Comment: not all secondary outcomes are reported as yet |
| Other bias | Unclear risk | Comment: changes made from protocol during trial to intervention of implementation i.e. group psychotherapy could commence more than 8 weeks after randomisation Comment: trial fidelity and therapist adherence described in Albus 2011 |