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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Anxiety, Cardiac Rehabilitation, Psychological Distress

Intervention / Treatment
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* Other: Home-based Metacognitive Therapy (Home-MCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants allocated to the control group will receive treatment as usual for cardiac rehabilitation | |
| Active Comparator: Intervention<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |