Study Stopped
Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.
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
1 other identifier
interventional
242
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started May 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2019
CompletedFirst Submitted
Initial submission to the registry
June 24, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2020
CompletedMarch 22, 2023
March 1, 2023
1.2 years
June 24, 2019
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.
Baseline, 4 months follow up
Secondary Outcomes (8)
Metacognitions Questionnaire 30 (MCQ-30)
Baseline, 4 months follow up
Cognitive Attentional Syndrome Scale (CAS-1)
Baseline, 4 months follow up
Impact of Events Scale - Revised (IES-R)
Baseline, 4 months follow up
Health Related Quality of Life (EQ-5D-5L)
Baseline, 4 months follow up
Credibility questionnaire (regarding the Home-MCT intervention)
From the completion of the introduction of the Home-MCT manual up to 2 weeks
- +3 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONParticipants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Intervention
ACTIVE COMPARATORParticipants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients who are referred to the CR pathway who meet Department of Health (DoH) and/or British Association for Cardiovascular Prevention and Rehabilitation (BACPR) CR eligibility criteria:
- Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
- Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
- Stable heart failure
- Stable angina is chest pain or discomfort that most often occurs with activity or stress
- Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
- Heart valve repair/replacement
- Heart transplantation and ventricular assist devices
- Adult congenital heart disease identified in adulthood
- Other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain)
- A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
- Minimum of 18 years old
- Competent level of English language skills
You may not qualify if:
- Cognitive impairment which precludes informed consent or ability to participate
- Acute suicidality
- Active psychotic disorders (i.e., two \[or more\] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
- Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
- Concurrent psychological intervention for emotional distress that is not part of usual care
- Antidepressant or anxiolytic medications initiated in the previous 8 weeks
- Life expectancy of less than 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manchesterlead
- Greater Manchester Mental Health NHS Foundation Trustcollaborator
- University of Liverpoolcollaborator
Study Sites (5)
Bolton NHS Foundation Trust
Bolton, United Kingdom
Aintree Liverpool NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
East Cheshire Nhs Trust
Macclesfield, SK10 3BL, United Kingdom
Pennine acute hospitals nhs trust
Manchester, BL9 7TD, United Kingdom
Manchester Foundation Trust
Manchester, United Kingdom
Related Publications (1)
Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial. PLoS Med. 2023 Jan 31;20(1):e1004161. doi: 10.1371/journal.pmed.1004161. eCollection 2023 Jan.
PMID: 36719886RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 24, 2019
First Posted
June 26, 2019
Study Start
May 14, 2019
Primary Completion
August 7, 2020
Study Completion
August 7, 2020
Last Updated
March 22, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share