Clinical trial NCT03129282: Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients
Official title: A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2017-04-26
Enrollment: 108
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 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.


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: Acceptability
timeFrame: From the completion of the manual till 4 months
Secondary outcomes:
measure: Change in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Metacognitions Questionnaire 30 (MCQ-30)
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Cognitive Attentional Syndrome Scale (CAS-1)
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Health Related Quality of Life (EQ-5D)
timeFrame: Baseline, 4 months follow up, 12 months follow up
measure: Economic Patient Questionnaire (EPQ)
timeFrame: Baseline, 4 months follow up, 12 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: Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT)
timeFrame: Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention
Other outcomes:
Locations:
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Aintree Liverpool NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Adrian Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy self-help for anxiety-depression: Single-blind randomized feasibility trial in cardiovascular disease. Health Psychol. 2022 May;41(5):366-377. doi: 10.1037/hea0001168.
citation: Wells A, Reeves D, Heal C, Davies LM, Shields GE, Heagerty A, Fisher P, Doherty P, Capobianco L. Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme. Front Psychiatry. 2022 Jun 3;13:886407. doi: 10.3389/fpsyt.2022.886407. eCollection 2022.
citation: Wells A, McNicol K, Reeves D, Salmon P, Davies L, Heagerty A, Doherty P, McPhillips R, Anderson R, Faija C, Capobianco L, Morley H, Gaffney H, Heal C, Shields G, Fisher P. Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT). Trials. 2018 Aug 16;19(1):444. doi: 10.1186/s13063-018-2826-x.