NCT03999359

A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)

A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings. This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a self-help format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to evaluate the effectiveness and cost-effectiveness of Home-MCT.

Conditions

• Depression
• Anxiety
• Cardiac Rehabilitation
• Psychological Distress

Interventions

Type	Name	Description
OTHER	Home-based Metacognitive Therapy	Home-based metacognitive therapy (Home-MCT) is a facilitated self-help manual comprising six modules which participants will complete at their own pace over approximately 6 weeks. Participants will have an initial appointment with a Home-MCT trained cardiac rehabilitation staff members (face to face or by telephone). In addition, they will receive two telephone calls from trained cardiac rehabilitation staff members over the course of the intervention to offer support with completing the modules of the self-help manual.

Timeline

• Start date: 2019-05-14
• Primary completion: 2020-08-07
• Completion: 2020-08-07
• First posted: 2019-06-26
• Last updated: 2023-03-22

Locations

5 sites across 1 country: United Kingdom