Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

Not Applicable

Completed

• Conditions: Depression; Cardiac Rehabilitation; Anxiety
• Interventions: Behavioral: Metacognitive Therapy; Behavioral: Cardiac Rehabilitation (treatment as usual)

• Registration Number: NCT02420431
• Lead Sponsor: University of Manchester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Study Start: 2015-07
• Primary Completion: 2019-02
• Study Completion: 2019-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metacognitive therapy plus CR	Metacognitive Therapy	Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation)
CR alone (control)	Cardiac Rehabilitation (treatment as usual)	Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education

Primary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS)	Baseline pre treatment, four-month post baseline

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life (EQ-5D)	Baseline, four-month post baseline, 12 months follow-up
Hospital Anxiety and Depression Scale	12 month follow-up
Impact of Events Scale -revised	Baseline, four-month post baseline, 12 months follow-up
Cognitive Attentional Syndrome scale (CAS-1)	Baseline, four-month post baseline, 12 months follow-up
Economic Patient Questionnaire	Baseline, 4 month follow-up, 12 months follow-up
Metacognitions Questionnaire 30	Baseline, four-month post baseline, 12 month follow-up

Trial Locations

Locations (5)

Macclesfield District General Hospital; 🇬🇧 Macclesfield, Cheshire, United Kingdom

University Hospital of South Manchester NHS Foundation Trust; 🇬🇧 Manchester, Lancashire, United Kingdom

Pennine Acute Hospitals NHS Trust; 🇬🇧 Manchester, United Kingdom

Stepping Hill Hospital; 🇬🇧 Manchester, United Kingdom

Central Manchester University Hospitals NHS Foundation Trust; 🇬🇧 Manchester, Lancashire, United Kingdom