Depression, Anxiety, Cardiac Rehabilitation
Conditions
Brief summary
Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life, and reduce the risk of further cardiac events. Depression and anxiety (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. The investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone.
Interventions
BEHAVIORALMetacognitive Therapy
Metacognitive therapy (MCT) helps clients to identify episodes of worry and rumination in response to negative thoughts and bring these responses under control. This process is facilitated by exercises that enhance the flexibility of attention control, challenge unhelpful beliefs about thinking and enable new relationships with thoughts
BEHAVIORALCardiac Rehabilitation (treatment as usual)
Stress management, relaxation training, exercise and dietary advice.
Sponsors
National Institute for Health Research, United Kingdom
Manchester Mental Health & Social Care Trust
University of Liverpool
University of Manchester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart disease patients referred to CR with: Acute coronary syndrome * Following revascularisation; stable heart failure * Stable angina, implanted cardioverter defibrillators * Heart valve repair/replacement * Heart transplantation and ventricular assist devices * Adult congenital heart disease * Must have a score of 8 or more on either the depression or anxiety subscale of the HADS * Competent level of English language skills
Exclusion criteria
* Cognitive impairment which precludes informed consent/ability to participate * Acute suicidality * Active psychotic disorders * Current drug/alcohol abuse * Concurrent psychological intervention for emotional distress * Antidepressant or anxiolytic medication initiated in previous 8 weeks * Life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) | Baseline pre treatment, four-month post baseline |
Secondary
| Measure | Time frame |
|---|---|
| Metacognitions Questionnaire 30 | Baseline, four-month post baseline, 12 month follow-up |
| Cognitive Attentional Syndrome scale (CAS-1) | Baseline, four-month post baseline, 12 months follow-up |
| Impact of Events Scale -revised | Baseline, four-month post baseline, 12 months follow-up |
| Economic Patient Questionnaire | Baseline, 4 month follow-up, 12 months follow-up |
| Hospital Anxiety and Depression Scale | 12 month follow-up |
| Health Related Quality of Life (EQ-5D) | Baseline, four-month post baseline, 12 months follow-up |
Countries
United Kingdom
Outcome results
None listed