Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients
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|ClinicalTrials.gov Identifier: NCT03129282|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety Cardiac Rehabilitation Psychological Distress||Other: Home-based Metacognitive Therapy (Home-MCT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)|
|Actual Study Start Date :||April 4, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2021|
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.
- Acceptability [ Time Frame: 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.
- Change in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]The HADS is a 14-item self-report scale assessing anxiety and depression
- Metacognitions Questionnaire 30 (MCQ-30) [ Time Frame: 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
- Cognitive Attentional Syndrome Scale (CAS-1) [ Time Frame: 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
- Impact of Events Scale - Revised (IES-R) [ Time Frame: 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
- Health Related Quality of Life (EQ-5D) [ Time Frame: 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
- Economic Patient Questionnaire (EPQ) [ Time Frame: 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
- Credibility questionnaire (regarding the Home-MCT intervention) [ Time Frame: 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
- Adherence questionnaire (regarding the Home-MCT intervention) [ Time Frame: From the completion of the manual up to 4 months ]This is a 6-item self-report questionnaire assessing adherence to Home-MCT
- Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129282
|Contact: Adrian Wells, PhD||00 44 161 276 email@example.com|
|Contact: Cintia Faija, PhD||00 44 161 276 firstname.lastname@example.org|
|Bolton NHS Foundation Trust||Recruiting|
|Bolton, United Kingdom|
|Contact: Joanne Varker|
|Aintree Liverpool NHS Foundation Trust||Recruiting|
|Liverpool, United Kingdom|
|Contact: Davies Gershan|
|Principal Investigator:||Adrian Wells, PhD||University of Manchester|