Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway (PATHWAY)

University of Manchester

Status: Completed

Conditions: Cardiac Rehabilitation; Depression; Anxiety

Treatments: Behavioral: Cardiac Rehabilitation (treatment as usual); Behavioral: Metacognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02420431

156862 (RP-PG-1211-20011)

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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332 participants in 2 patient groups

metacognitive therapy plus CR

Experimental group

Description:

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

Treatment:

Behavioral: Metacognitive Therapy

CR alone (control)

Active Comparator group

Description:

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

Treatment:

Behavioral: Cardiac Rehabilitation (treatment as usual)