Freedland 2009.
| Methods | RCT design: 3‐arm parallel‐group trial Total N randomised: 123 Length of follow‐up: 6 months Analysis: Intention‐to‐treat (ITT) |
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| Participants | Location: USA Number of study centres and setting: Patients who had undergone Coronary Artery Bypass Surgery (CABG) from 3 hospitals CAD diagnosis: Coronary Artery Bypass Surgery (CABG), randomisation within 12 months after surgery Depression diagnosis: Beck Depression Inventory (BDI) score of 10 or higher and current major or minor depressive episode assessed with the Depression Interview and Structured Hamilton (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, noncardiac illnesses with a poor 1‐year prognosis, being too medically ill or living too far away to participate, being unable to communicate in English, or for 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) significantly higher than in the other arms |
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| Interventions | Treatment 1: Individual Cognitive Behavior Therapy (CBT) (weekly 1‐hour sessions) including target problem identification, problem solving, behavioral activation, cognitive techniques (challenging distressing automatic thoughts, changing dysfunctional attitudes), self‐therapy and relapse‐prevention skills Treatment 2: Supportive Stress Management (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: Hamilton Depression Rating Scale depression remission (HAM‐D < 7), HAM‐D score, BDI depression remission, BDI score, Medical Outcomes Study Short‐Form 36‐item Health Survey (SF‐36) Other outcomes: Beck Anxiety Inventory, Beck Hopelessness Scale, Perceived Stress Scale, Heart Surgery Questionnaire (HSQ), Digit Symbol test, part B of the Trailmaking Test, a paragraph recall test, and the Short Blessed Test to assess cognitive impairment after CABG surgery |
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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 (performance bias and 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 | |