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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129282
• Other study ID #: 186990 (RP-PG-1211-20011)
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: March 14, 2019

Study information

• Verified date: March 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 14, 2019
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cardiac Rehabilitation
• Depression
• Psychological Distress

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Bolton NHS Foundation Trust	Bolton
United Kingdom	Aintree Liverpool NHS Foundation Trust	Liverpool

Sponsors (3)

Lead Sponsor	Collaborator
University of Manchester	Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Web-site with details about the study