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

Not Applicable

Completed

• Conditions: Cardiac Rehabilitation; Psychological Distress; Anxiety; Depression
• Interventions: Other: Home-based Metacognitive Therapy (Home-MCT)

• Registration Number: NCT03129282
• Lead Sponsor: University of Manchester

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Primary Completion: 2018-06-20
• Study Completion: 2019-03-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Home-based Metacognitive Therapy (Home-MCT)	Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)

Primary Outcome Measures

Name	Time	Method
Acceptability	From the completion of the manual till 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Adherence questionnaire (regarding the Home-MCT intervention)	From the completion of the manual up to 4 months	This is a 6-item self-report questionnaire assessing adherence to Home-MCT
Cognitive Attentional Syndrome Scale (CAS-1)	Baseline, 4 months follow up, 12 months follow up	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
Metacognitions Questionnaire 30 (MCQ-30)	Baseline, 4 months follow up, 12 months follow up	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
Health Related Quality of Life (EQ-5D)	Baseline, 4 months follow up, 12 months follow up	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
Credibility questionnaire (regarding the Home-MCT intervention)	From the completion of the introduction of the Home-MCT manual up to 2 weeks	This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress
Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT)	Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention	Interviews are aimed to explore patient's experiences of going through the Home-MCT intervention
Change in the Hospital Anxiety and Depression Scale (HADS)	Baseline, 4 months follow up, 12 months follow up	The HADS is a 14-item self-report scale assessing anxiety and depression
Impact of Events Scale - Revised (IES-R)	Baseline, 4 months follow up, 12 months follow up	The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events
Economic Patient Questionnaire (EPQ)	Baseline, 4 months follow up, 12 months follow up	The EPQ assesses the services the patients have used as part of their health and social care

Trial Locations

Locations (2)

Bolton NHS Foundation Trust; 🇬🇧 Bolton, United Kingdom

Aintree Liverpool NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom