MoodCare 2011.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 121 Length of follow‐up: 6 months, 18 months Analysis: ITT with last‐observation‐carried‐forward (8 dropouts in intervention group, 7 dropouts in control group at 6‐month follow‐up) |
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| Participants | Location: Australia Number of study centres and setting: multicentre; 6 metropolitan hospitals in the states of Victoria (Austin, St. Vincent's, Geelong, Royal Melbourne Hospitals) and Queensland (Royal Brisbane and Women's and The Prince Charles Hospitals). CAD criteria: clinical diagnosis of ACS (MI (ST segment elevation MI, STEMI or non‐STEMI) or unstable angina confirmed by angiogram) Depression criteria: depression (PHQ‐9) score of 5 to 19 Other entry criteria: age between 21 and 85, fluency in English, availability via the telephone for the duration of the study Exclusion criteria: regular psychological therapy with a mental health professional at the time of admission for ACS, diagnosis of mental health condition which may impact on involvement (including bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder), cognitive impairment impacting ability to participate in the study, diagnosed with a terminal illness, unable to participate in a tele‐based unsupervised mood and lifestyle intervention as confirmed by treating clinician Treatment N: 61 (26.2% female, mean age: 61.0 (SD: 10.2)) Control N: 60 (23.3% female, mean age: 58.9 (SD: 10.7)) Comparability of groups: no significant baseline differences except for a significantly higher proportion of participants in the treatment group being born in Australia and had visited a general practitioner in the past 6 months |
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| Interventions | Treatment: CBT intervention with structured counselling sessions (2 weeks baseline screening delivered by qualified psychologists, intervention aims to manage depression as well as CHD risk factor behaviours using a tele‐based care management model incorporating CBT counselling; psychologists with at least 2 years of experience deliver the intervention, content: cognitive restructuring, behavioural activation, goal setting, motivational interviewing techniques); participants received 10 sessions lasting 30 to 40 minutes, unless target recovery was achieved prior to programme completion (in this event, the interventionists reviewed the individual case with the senior clinical consultant, and if the participant produced a PHQ score in the normal range for 3 consecutive counselling sessions, after completing at least 4 sessions, the participant was considered to have met target recovery). Additonally, participants received a brief National Heart Foundation of Australia education pamphlet on MI recovery. Control: usual care and a brief National Heart Foundation of Australia education pamphlet on MI recovery Duration of treatment: 6 months |
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| Outcomes | Review outcomes: depression symptoms (PHQ‐9), quality of life (12‐Item Short Form Health Survey) Other outcomes: cardiac depression (Cardiac Depression Scale), acceptability, feasibility |
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| Funding | Australian Government Department of Health and Ageing | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: automatically generated separate block randomization (integrated into web‐based database), process concealed from investigators |
| Allocation concealment (selection bias) | Low risk | Comment: automatic group allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: randomisation schedule was concealed from investigators, participants were asked not to reveal the group to which they were randomised |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: project staff who administered telephone questionnaires were blinded to participans´study group. Primary outcome was a self‐report measure (PHQ‐9) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT |
| Selective reporting (reporting bias) | Low risk | Comment: Study protocol available and congruent |
| Other bias | Unclear risk | Comment: manualised intervention and therapist quality assessed by Cognitive Therapy Scale Comment: therapist adherence monitored by audiotape of phonecalls; only 17% reviewed by expert psychiatrist as specified in protocol |