Burell 1996a.
Study characteristics | ||
Methods |
Design: multicentre RCT. Country: Sweden. Dates participants recruited: NR. Participants recruited (number of sites): hospital (14). Maximum follow‐up: 6.5 years. Follow‐up schedule: 6.5 years. |
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Participants |
Inclusion criteria: CABG 3‐12 months prior to recruitment, non‐smokers. Exclusion criteria: diabetes mellitus, other somatic or psychiatric disease or alcoholism, and non‐Swedish speakers. Indication (% participants): CABG (100%). Psychopathology: NR. Number randomised: total: 261; intervention: 128; comparator: 133. Age (mean ± SD): total: 57.5 (SD NR) years; intervention: NR; comparator: NR. Men: total: 86%; intervention: NR; comparator: NR. Ethnicity (% white): NR. |
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Interventions |
INTERVENTION: initial treatment (6 sessions) focused on education about CHD, surgical issues, risk factors and risk behaviours, psychological factors that influence wellbeing and Type A behaviour. From the first session, participants were given homework assignments related to observation of health behaviours. The remaining session focused on modifying Type A prone behaviours: developing and applying new reactions and behaviours that entailed less impatience, irritation, hostility, depression, and distress. Treatment targets: risk education, disease adjustment, and coronary prone behaviours (Type A behaviour, depressive reactions, anxiety). Components: risk information, guidance on behaviour change, self‐awareness/monitoring, relaxation, homework. Treatment setting (number of sites): NR (NR). Modality (group size): group (5‐9 participants). Dose:
Delivered by: cardiologist and nutritionist (1 session) and clinical psychologist (remainder of sessions). Follow‐up further reinforcement: 5 or 6 booster sessions in years 2 and 3. Cointerventions: access to rehabilitation programmes that were part of usual care. COMPARATOR: usual care, including access to rehabilitation programmes that were regularly offered by participating hospitals. Cointerventions: NR. |
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Outcomes | Total mortality. Cardiac mortality. Non‐fatal MI. Revascularisation (CABG (reoperation) and PTCA). Self‐reported Type A behaviour. |
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Source of funding | NR. | |
Conflicts of interest | NR. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated participants were randomly assigned. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to judge, attrition appeared to be zero. |
Selective reporting (reporting bias) | Unclear risk | Method did not fully specify the measures used. |
Groups balanced at baseline | High risk | Control participants were significantly younger than those in the intervention group. |
Intention‐to‐treat analysis | Unclear risk | Intention‐to‐treat analysis was not described, and no n values were provided in Table 2. |
Groups received same cointerventions | Low risk | "Both experimental and control patients had access to rehabilitation programmes that were regularly offered by their hospitals." |