Back to resultsPathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients
Primary Purpose
Depression, Anxiety, Cardiac Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home-based Metacognitive Therapy (Home-MCT)
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Bolton NHS Foundation Trust
- Aintree Liverpool NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Intervention
Arm Description
Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-report scale assessing anxiety and depression
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
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
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
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
Economic Patient Questionnaire (EPQ)
The EPQ assesses the services the patients have used as part of their health and social care
Credibility questionnaire (regarding the Home-MCT intervention)
This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress
Adherence questionnaire (regarding the Home-MCT intervention)
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)
Interviews are aimed to explore patient's experiences of going through the Home-MCT intervention
Full Information
NCT ID
NCT03129282
First Posted
April 11, 2017
Last Updated
March 20, 2023
Sponsor
University of Manchester
Collaborators
Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool
1. Study Identification
Unique Protocol Identification Number
NCT03129282
Brief Title
Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients
Official Title
A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
March 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Cardiac Rehabilitation, Psychological Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)
Intervention Type
Other
Intervention Name(s)
Home-based Metacognitive Therapy (Home-MCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
From the completion of the manual till 4 months
Secondary Outcome Measure Information:
Title
Change in the Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14-item self-report scale assessing anxiety and depression
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Metacognitions Questionnaire 30 (MCQ-30)
Description
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
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Cognitive Attentional Syndrome Scale (CAS-1)
Description
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
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Impact of Events Scale - Revised (IES-R)
Description
The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Health Related Quality of Life (EQ-5D)
Description
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
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Economic Patient Questionnaire (EPQ)
Description
The EPQ assesses the services the patients have used as part of their health and social care
Time Frame
Baseline, 4 months follow up, 12 months follow up
Title
Credibility questionnaire (regarding the Home-MCT intervention)
Description
This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress
Time Frame
From the completion of the introduction of the Home-MCT manual up to 2 weeks
Title
Adherence questionnaire (regarding the Home-MCT intervention)
Description
This is a 6-item self-report questionnaire assessing adherence to Home-MCT
Time Frame
From the completion of the manual up to 4 months
Title
Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT)
Description
Interviews are aimed to explore patient's experiences of going through the Home-MCT intervention
Time Frame
Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Wells, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolton NHS Foundation Trust
City
Bolton
Country
United Kingdom
Facility Name
Aintree Liverpool NHS Foundation Trust
City
Liverpool
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35467904
Citation
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.
Results Reference
result
PubMed Identifier
35722590
Citation
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.
Results Reference
derived
PubMed Identifier
30115112
Citation
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.
Results Reference
derived
Links:
URL
http://www.adept-ru.com
Description
Web-site with details about the study
Learn more about this trial
Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients
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