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

University of Manchester

Status: Terminated

Conditions: Cardiac Rehabilitation; Depression; Anxiety; Psychological Distress

Treatments: Other: Home-based Metacognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03999359

186990 RP-PG-1211-20011

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

Control

No Intervention group

Description:

Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation

Intervention

Active Comparator group

Description:

Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)

Treatment:

Other: Home-based Metacognitive Therapy