Freedland 2009.
| Study characteristics | ||
| Methods | RCT design: 3‐arm parallel‐group trial Total N randomised: 123 Length of follow‐up: 6 months Analysis: ITT with multiple imputation |
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| Participants | Location: USA Number of study centres and setting: patients who had undergone CABG from 3 hospitals CAD criteria: CABG, randomisation within 12 months after surgery Depression criteria: BDI score of 10 or higher and current major or minor depressive episode assessed with the DISH Other entry criteria: patients aged 21 years or older Exclusion criteria: severe psychiatric comorbidities (schizophrenia or bipolar disorder), active alcoholism or substance abuse, severe cognitive impairment, non‐cardiac illnesses with a poor 1‐year prognosis, being too medically ill or living too far away to participate, unable to communicate in English, or receiving ongoing psychotherapeutic services Treatment 1 (CBT) N: 41 (56% female, mean age: 62 (SD: 11)) Treatment 2 (SSM) N: 42 (50% female, mean age: 59 (SD: 10)) Control N: 40 (43% female, mean age: 61 (SD: 9)) Comparability of groups: proportion of African‐American participants in treatment 2 (SSM) was significantly higher than in the other study arms |
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| Interventions | Treatment 1: individual CBT (weekly 1‐hour sessions) including target problem identification, problem‐solving, behavioural activation, cognitive techniques (challenging distressing automatic thoughts, changing dysfunctional attitudes), self‐therapy and relapse‐prevention skills Treatment 2: SSM (weekly 1‐hour sessions) including patient education regarding stress and coping, practice in progressive muscle relaxation training, controlled breathing and relaxing imagery Control: usual care for depression Duration of treatment: 12 weeks |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D, also BDI‐II), depression remission (HAM‐D ≤ 6), quality of life (36‐Item Short Form Health Survey) Other outcomes: anxiety symptoms (Beck Anxiety Inventory), hopelessness (Beck Hopelessness Scale), stress (Perceived Stress Scale), Heart Surgery Questionnaire (HSQ), cognitive function (digit symbol test, Trail Making Test‐part B, paragraph recall, Short Blessed Test) |
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| Funding | National Institute of Mental Health, USA | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Computer‐generated random allocation sequence with block sizes of 3 and 6 |
| Allocation concealment (selection bias) | Low risk | Comment: Concealed in sealed envelopes and revealed to the study coordinator immediately after the participant completed all of the baseline assessments |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: single‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The outcome assessors were masked to the participants' group assignments" (p. 389) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: Missing data "plausibly missing at random" (p. 389) Comment: Missing outcome data imputed |
| Selective reporting (reporting bias) | Low risk | Comment: Outcomes reported in accordance to the study protocol |
| Other bias | Low risk | Comment: 94% of intervention sessions taped for quality assurance; trial fidelity quantified by a Treatment Process Scale after each session. The measure was developed for the study; Comment: manualised CBT treatment with weekly supervision; SSM intervention not manualised |