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

March 20, 2023 updated by: Adrian Wells, University of Manchester

A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bolton, United Kingdom
        • Bolton NHS Foundation Trust
      • Liverpool, United Kingdom, L9 7AL
        • Aintree Liverpool NHS Foundation Trust
      • Macclesfield, United Kingdom, SK10 3BL
        • East Cheshire NHS Trust
      • Manchester, United Kingdom, BL9 7TD
        • Pennine Acute Hospitals NHS Trust
      • Manchester, United Kingdom
        • Manchester Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 4 months follow up
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.
Baseline, 4 months follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metacognitions Questionnaire 30 (MCQ-30)
Time Frame: Baseline, 4 months follow up
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.
Baseline, 4 months follow up
Cognitive Attentional Syndrome Scale (CAS-1)
Time Frame: Baseline, 4 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. 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.
Baseline, 4 months follow up
Impact of Events Scale - Revised (IES-R)
Time Frame: Baseline, 4 months follow up
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.
Baseline, 4 months follow up
Health Related Quality of Life (EQ-5D-5L)
Time Frame: Baseline, 4 months follow up
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.
Baseline, 4 months follow up
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. 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.
From the completion of the introduction of the Home-MCT manual up to 2 weeks
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. 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.
From the completion of the manual up to 4 months
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 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.
From the completion of the manual till 4 months
Economic Patient Questionnaire (EPQ)
Time Frame: Baseline, 4 months follow up
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.
Baseline, 4 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Liverpool
Greater Manchester Mental Health NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 186990 RP-PG-1211-20011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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