MOODCARE: Evaluation of telephone delivered health care for depression in patients following myocardial infarction

Project Team

Project Outline

Funding
This study is funded by the Commonwealth Department of Health and Ageing from 2009-2011. The study team is a group of internationally renowned, highly experienced investigators from Australia and the United States.

Background
It has been estimated that at least 20% of people suffer from major depression and related emotional problems after myocardial infarction (MI) or heart attack, which is associated with poor adherence to treatment and an increase in other health-related problems. However, depression remains seriously under-recognised and under-treated by health professionals. Tele-based support improves the reach and flexibility of secondary prevention programs and has been shown to be effective for a wide range of health problems including depression and other mood disorders. For the first time, we are conducting a state-of-the-art randomised controlled trial (RCT) of a telephone-delivered secondary prevention program for Acute Coronary Syndrome (ACS) patients diagnosed with depression (MOOD-CARE).

Aim
To investigate the effectiveness of a telephone-delivered intervention (MOOD-CARE) for depressed ACS patients on health outcomes post-intervention, and assess the cost-effectiveness of this approach.
Participants

Eligibility criteria includes: a clinical diagnosis consistent with that of Acute Coronary Syndrome (ACS) (MI [STEMI or non STEMI], unstable angina, confirmed on angiography);  aged 21-85 years; fluency in English; availability via the telephone for the duration of the study; and a Patient Health Questionnaire (PHQ9) score of 5-19. Patients are excluded if they are: participating in regular psychological therapy with a mental health professional at the time of admission for ACS; diagnosed with a psychiatric condition which may impact on involvement (including bipolar illness, psychotic illness of any type, dementia, acute suicidality, severe personality disorder);  cognitively impaired impacting on their ability to participate in the study; diagnosed with a terminal illness; or unable to participate in a tele-based unsupervised mood and lifestyle intervention as confirmed by the treating clinician.

Over a 14 month period, we are screening up to 1910 ACS patients for depression in six hospitals in Victoria and Queensland. Participants are then followed up over the telephone by a Research Assistant to complete baseline data collection, within two weeks of discharge. Eligible participants are randomly assigned to a Usual Care/Control group or the Intervention group.

Study Conditions
MOOD-CARE includes up to 10 telephone counselling sessions, delivered by registered psychologists, using Cognitive Behaviour Therapy for the management of depression and coronary heart disease (CHD) risk factor management, consistent with the Heart Foundation guidelines. Psychologists aim to reduce symptoms of depression (using the Cardiac Depression Scale), as well as improve coronary heart disease risk factors and overall quality of life (using the SF-12).

Key Outcomes
Data collection will occur at baseline and six months (post-intervention). Participants will be asked to complete a telephone-delivered questionnaire assessing depression, anxiety, quality of life, employment status and productivity and social support outcomes. Participants will also be asked to complete a paper-based survey containing questions about physical activity, smoking, alcohol, fat and fibre intake, medication taking and health service utilisation. The primary endpoints are depression and quality of life at six month follow up.

Significance
If demonstrated to be effective, this novel program has the potential to improve psychological, physical, social and vocational functioning in individuals who are depressed following ACS. This tele-based approach has the potential to reduce demands on the health system. The study will also provide information on the economic value of the program and key information concerning its future translatability to and uptake into the health system.

Key Outcomes

If demonstrated to be effective, this novel intervention program has the potential to improve psychological, physical, social and vocational functioning in individuals who are depressed following MI, as well as to reduce demands on the health system. It also has the potential to extend survival for the rapidly growing number of CHD patients, although this will not be detectable in this trial. The study will also provide information on the economic value of the program and key information concerning its future translatability to and uptake into the health system.