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A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)

Primary Purpose

Depression, Anxiety, Cardiac Rehabilitation

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home-based Metacognitive Therapy
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    -

Sites / Locations

  • Bolton NHS Foundation Trust
  • Aintree Liverpool NHS Foundation Trust
  • East Cheshire Nhs Trust
  • Pennine acute hospitals nhs trust
  • Manchester 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

Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.

Secondary Outcome Measures

Metacognitions Questionnaire 30 (MCQ-30)
The MCQ-30 is a 30-item self-report scale that assesses metacognitive beliefs across five subscales: a) Cognitive Confidence, b) Positive Beliefs about Worry, c) Cognitive Self-Consciousness, d) Negative Beliefs about Uncontrollability and Dangerousness of worry, and e) Need to Control Thoughts .Each item is rated on a 4-point Likert scale, with 1 representing "do not agree" , and with 4 indicating "agree very much." Subscale scores range from 6-24 whilst total scores range from 30-120. Subscale scores are created by summing responses to the selected items. Higher subscale scores and total scores, indicate greater dysfunctional metacognitive beliefs.
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. Responses to these items are on 0 to 100 scale, with higher scores indicating greater use of maladaptive coping strategies and higher positive and negative metacognitive beliefs.
Impact of Events Scale - Revised (IES-R)
The IES-R is a 22-item self-report measure that assesses symptoms of post-traumatic stress disorder. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores range from 0-88, with higher scores indicating higher levels of subjective distress caused by traumatic events.
Health Related Quality of Life (EQ-5D-5L)
The ED-5D-5L is a standardised questionnaire for use as a measure of health status. The ED-5D-5L consists of 2 parts: a descriptive system and a visual analogue scale. The descriptive system consist of 5 separate dimensions which include mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients report the severity of problems they face concerning each dimension, with responses ranging from 1-5, whereby higher scores indicate more severe problems. These numbers can then be combined for each dimension to provide a 5 digit value for describing the patients' health state. The visual analogue component of the ED-5D-5L consists of the patient/participant rating their own health that day, on a scale of 0-100 with 100 indicating the best health they can imagine and 0 indicating the worst health they can imagine.
Credibility questionnaire (regarding the Home-MCT intervention)
This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress. Items are rated from 0 to 100, where 0 indicates less credibility of the home-MCT manual, and 100 indicates greater credibility of the home-MCT manual.
Adherence questionnaire (regarding the Home-MCT intervention)
This is a 6-item self-report questionnaire assessing adherence to Home-MCT. Items are rated on a scale from 0 (not at all easy) to 100 (extremely easy). Items assess easy of use and clarity of the manual. Greater scores indicate greater adherence to the manual.
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 the percentage of all patients randomised to the treatment arm, minus deaths. This will be compared to the percentage of controls (minus deaths) who complete the 4-month follow up.
Economic Patient Questionnaire (EPQ)
The EPQ assesses the services the patients have used as part of their health and social care. Patients indicate the type and frequency of visits to in-patient, out-patient, and/or community services.

Full Information

First Posted
June 24, 2019
Last Updated
March 20, 2023
Sponsor
University of Manchester
Collaborators
Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT03999359
Brief Title
A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)
Official Title
A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
August 7, 2020 (Actual)
Study Completion Date
August 7, 2020 (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
Data Monitoring Committee
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 self-help 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 evaluate the effectiveness and cost-effectiveness of 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
242 (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
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
Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.
Time Frame
Baseline, 4 months follow up
Secondary Outcome Measure Information:
Title
Metacognitions Questionnaire 30 (MCQ-30)
Description
The MCQ-30 is a 30-item self-report scale that assesses metacognitive beliefs across five subscales: a) Cognitive Confidence, b) Positive Beliefs about Worry, c) Cognitive Self-Consciousness, d) Negative Beliefs about Uncontrollability and Dangerousness of worry, and e) Need to Control Thoughts .Each item is rated on a 4-point Likert scale, with 1 representing "do not agree" , and with 4 indicating "agree very much." Subscale scores range from 6-24 whilst total scores range from 30-120. Subscale scores are created by summing responses to the selected items. Higher subscale scores and total scores, indicate greater dysfunctional metacognitive beliefs.
Time Frame
Baseline, 4 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. Responses to these items are on 0 to 100 scale, with higher scores indicating greater use of maladaptive coping strategies and higher positive and negative metacognitive beliefs.
Time Frame
Baseline, 4 months follow up
Title
Impact of Events Scale - Revised (IES-R)
Description
The IES-R is a 22-item self-report measure that assesses symptoms of post-traumatic stress disorder. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores range from 0-88, with higher scores indicating higher levels of subjective distress caused by traumatic events.
Time Frame
Baseline, 4 months follow up
Title
Health Related Quality of Life (EQ-5D-5L)
Description
The ED-5D-5L is a standardised questionnaire for use as a measure of health status. The ED-5D-5L consists of 2 parts: a descriptive system and a visual analogue scale. The descriptive system consist of 5 separate dimensions which include mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients report the severity of problems they face concerning each dimension, with responses ranging from 1-5, whereby higher scores indicate more severe problems. These numbers can then be combined for each dimension to provide a 5 digit value for describing the patients' health state. The visual analogue component of the ED-5D-5L consists of the patient/participant rating their own health that day, on a scale of 0-100 with 100 indicating the best health they can imagine and 0 indicating the worst health they can imagine.
Time Frame
Baseline, 4 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. Items are rated from 0 to 100, where 0 indicates less credibility of the home-MCT manual, and 100 indicates greater credibility of the home-MCT manual.
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. Items are rated on a scale from 0 (not at all easy) to 100 (extremely easy). Items assess easy of use and clarity of the manual. Greater scores indicate greater adherence to the manual.
Time Frame
From the completion of the manual up to 4 months
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 the percentage of all patients randomised to the treatment arm, minus deaths. This will be compared to the percentage of controls (minus deaths) who complete the 4-month follow up.
Time Frame
From the completion of the manual till 4 months
Title
Economic Patient Questionnaire (EPQ)
Description
The EPQ assesses the services the patients have used as part of their health and social care. Patients indicate the type and frequency of visits to in-patient, out-patient, and/or community services.
Time Frame
Baseline, 4 months follow up

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 -
Facility Information:
Facility Name
Bolton NHS Foundation Trust
City
Bolton
Country
United Kingdom
Facility Name
Aintree Liverpool NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
East Cheshire Nhs Trust
City
Macclesfield
ZIP/Postal Code
SK10 3BL
Country
United Kingdom
Facility Name
Pennine acute hospitals nhs trust
City
Manchester
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Facility Name
Manchester Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36719886
Citation
Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial. PLoS Med. 2023 Jan 31;20(1):e1004161. doi: 10.1371/journal.pmed.1004161. eCollection 2023 Jan.
Results Reference
result
Links:
URL
http://www.adept-ru.com
Description
Web-site with details about the study

Learn more about this trial

A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)

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