NCT03129282

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

Completed NA Last updated 22 March 2023

What this trial tests

NA trial testing Home-based Metacognitive Therapy (Home-MCT) in Depression in 108 participants. Completed in 14 March 2019.

Timeline

4 April 2017

Primary endpoint
20 June 2018

14 March 2019

Quick facts

Lead sponsor	University of Manchester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	108
Start date	4 April 2017
Primary completion	20 June 2018
Estimated completion	14 March 2019
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Home-based Metacognitive Therapy (Home-MCT)

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
• Psychological Distress — all drugs for Psychological Distress →

Sponsor

University of Manchester

Who can join

18 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. A framework for implementing Patient and Public Involvement in mental health research: The PATHWAY research programme benchmarked against NIHR standards.
   Capobianco L, Faija C, Cooper B, Brown L, et al · · 2023 · cited 15× · PMID 36625226 · DOI 10.1111/hex.13676
2. Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT).
   Wells A, McNicol K, Reeves D, Salmon P, et al · · 2018 · cited 14× · PMID 30115112 · DOI 10.1186/s13063-018-2826-x
3. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.
   Wells A, Reeves D, Heal C, Fisher P, et al · · 2023 · cited 12× · PMID 36719886 · DOI 10.1371/journal.pmed.1004161
4. Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme.
   Wells A, Reeves D, Heal C, Davies LM, et al · · 2022 · cited 12× · PMID 35722590 · DOI 10.3389/fpsyt.2022.886407
5. Metacognitive therapy self-help for anxiety-depression: Single-blind randomized feasibility trial in cardiovascular disease.
   Wells A, Reeves D, Heal C, Fisher P, et al · · 2022 · cited 7× · PMID 35467904 · DOI 10.1037/hea0001168
6. Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in Cardiac Rehabilitation: The PATHWAY Research Programme Including 4 RCTs
   Wells A, Reeves D, Fisher P, Davies L, et al · · 2024 · PMID 39353053