Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

Study Overview
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Brief Summary
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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.

Official Title
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Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial

Conditions
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Depression, Anxiety, Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Metacognitive Therapy
* Behavioral: Cardiac Rehabilitation (treatment as usual)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metacognitive therapy plus CR<br>Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation) | Behavioral: Metacognitive Therapy<br>* 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<br>|
| Active Comparator: CR alone (control)<br>Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education | Behavioral: Cardiac Rehabilitation (treatment as usual)<br>* Stress management, relaxation training, exercise and dietary advice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hospital Anxiety and Depression Scale (HADS) |  | Baseline pre treatment, four-month post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Scale -revised |  | Baseline, four-month post baseline, 12 months follow-up | 
| 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 | 
| Health Related Quality of Life (EQ-5D) |  | 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 |