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Completed

NCT Number: NCT03129282

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiac Rehabilitation Mental Disorders Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolton NHS Foundation Trust, Bolton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Metacognitive Therapy (Home-MCT)

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Greater Manchester Mental Health NHS Foundation Trust
  • University of Liverpool

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 26, 2017
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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