Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-08-31

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.

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Detailed Description

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Conditions

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Depression Anxiety Cardiac Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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metacognitive therapy plus CR

Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation)

Group Type EXPERIMENTAL

Metacognitive Therapy

Intervention Type BEHAVIORAL

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

CR alone (control)

Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation (treatment as usual)

Intervention Type BEHAVIORAL

Stress management, relaxation training, exercise and dietary advice.

Interventions

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Metacognitive 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

Intervention Type BEHAVIORAL

Cardiac Rehabilitation (treatment as usual)

Stress management, relaxation training, exercise and dietary advice.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No