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Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients

NCT03129282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-03-22

No results posted yet for this study

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 home-based 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 provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.

Conditions

Interventions

OTHER

Home-based Metacognitive Therapy (Home-MCT)

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.

Sponsors & Collaborators

  • Greater Manchester Mental Health NHS Foundation Trust

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • University of Manchester

    lead OTHER

Principal Investigators

  • Adrian Wells, PhD · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2018-06-20
Completion
2019-03-14

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129282 on ClinicalTrials.gov