Clinical trial NCT03999359: 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
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Anxiety
Cardiac Rehabilitation
Psychological Distress
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Greater Manchester Mental Health NHS Foundation Trust
name: University of Liverpool
First posted: 2019-06-26
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

   -

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 4 months follow up
Secondary outcomes:
measure: Metacognitions Questionnaire 30 (MCQ-30)
timeFrame: Baseline, 4 months follow up
measure: Cognitive Attentional Syndrome Scale (CAS-1)
timeFrame: Baseline, 4 months follow up
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: Baseline, 4 months follow up
measure: Health Related Quality of Life (EQ-5D-5L)
timeFrame: Baseline, 4 months follow up
measure: Credibility questionnaire (regarding the Home-MCT intervention)
timeFrame: From the completion of the introduction of the Home-MCT manual up to 2 weeks
measure: Adherence questionnaire (regarding the Home-MCT intervention)
timeFrame: From the completion of the manual up to 4 months
measure: Acceptability
timeFrame: From the completion of the manual till 4 months
measure: Economic Patient Questionnaire (EPQ)
timeFrame: Baseline, 4 months follow up
Other outcomes:
Locations:
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Aintree Liverpool NHS Foundation Trust
city: Macclesfield
country: United Kingdom
facility: East Cheshire Nhs Trust
city: Manchester
country: United Kingdom
facility: Pennine acute hospitals nhs trust
city: Manchester
country: United Kingdom
facility: Manchester Foundation Trust
Study officials:
References:
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.