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

A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Psychological Distress; Cardiac Rehabilitation
• Intervention / Treatment: Other: Home-based Metacognitive Therapy (Home-MCT)

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bolton, United Kingdom
    • Bolton NHS Foundation Trust
  • Liverpool, United Kingdom
    • Aintree Liverpool NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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)
2. A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
3. Minimum of 18 years old
4. Competent level of English language skills

Exclusion Criteria:

1. Cognitive impairment which precludes informed consent or ability to participate
2. Acute suicidality
3. Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
4. Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
5. Concurrent psychological intervention for emotional distress that is not part of usual care
6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
7. Life expectancy of less than 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Active Comparator: Intervention; Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability of the intervention is defined as the completion of the first 4 modules of the Home-MCT manual, which includes 6 modules in total. Acceptability will be expressed as a % of all patients randomised to the treatment arm, minus deaths. This will be compared to the % of controls (minus deaths) who complete the 4-month follow up.	From the completion of the manual till 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item self-report scale assessing anxiety and depression	Baseline, 4 months follow up, 12 months follow up
Metacognitions Questionnaire 30 (MCQ-30)	The MCQ-30 is a 30-item self-report scale that measures: a) Lack of Cognitive Confidence, b) Positive Beliefs about Worry, c) Cognitive Self-Consciousness, d) Negative Beliefs about Uncontrollability and Danger, and e) Need to Control Thoughts	Baseline, 4 months follow up, 12 months follow up
Cognitive Attentional Syndrome Scale (CAS-1)	The CAS-1 is a 10-item self-report measure assessing: a) the degree to which individuals have been dwelling on or worrying and/or focusing attention on threats, b) strategies used to cope with negative feelings and thoughts, and c) the degree to which individuals hold positive and negative metacognitive beliefs about worry	Baseline, 4 months follow up, 12 months follow up
Impact of Events Scale - Revised (IES-R)	The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events	Baseline, 4 months follow up, 12 months follow up
Health Related Quality of Life (EQ-5D)	The ED-5D is a standardised questionnaire for use as a measure of health status. It assesses: a) mobility, b) self-care, c) usual activities, d) pain/discomfort, and e) anxiety/depression, and the overall health status	Baseline, 4 months follow up, 12 months follow up
Economic Patient Questionnaire (EPQ)	The EPQ assesses the services the patients have used as part of their health and social care	Baseline, 4 months follow up, 12 months follow up
Credibility questionnaire (regarding the Home-MCT intervention)	This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress	From the completion of the introduction of the Home-MCT manual up to 2 weeks
Adherence questionnaire (regarding the Home-MCT intervention)	This is a 6-item self-report questionnaire assessing adherence to Home-MCT	From the completion of the manual up to 4 months
Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT)	Interviews are aimed to explore patient's experiences of going through the Home-MCT intervention	Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: University of Liverpool; Greater Manchester Mental Health NHS Foundation Trust
• Investigators: Principal Investigator: Adrian Wells, PhD, University of Manchester

Publications and helpful links

General Publications

• Wells A, McNicol K, Reeves D, Salmon P, Davies L, Heagerty A, Doherty P, McPhillips R, Anderson R, Faija C, Capobianco L, Morley H, Gaffney H, Heal C, Shields G, Fisher P. 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). Trials. 2018 Aug 16;19(1):444. doi: 10.1186/s13063-018-2826-x.
• Wells A, Reeves D, Heal C, Davies LM, Shields GE, Heagerty A, Fisher P, Doherty P, Capobianco L. Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme. Front Psychiatry. 2022 Jun 3;13:886407. doi: 10.3389/fpsyt.2022.886407. eCollection 2022.
• Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy self-help for anxiety-depression: Single-blind randomized feasibility trial in cardiovascular disease. Health Psychol. 2022 May;41(5):366-377. doi: 10.1037/hea0001168.

Helpful Links

• Web-site with details about the study

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 186990 (RP-PG-1211-20011)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No