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

NCT03129282 | Completed

• 1 other identifier: 186990 (RP-PG-1211-20011)
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Anxiety; Cardiac Rehabilitation; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Acceptability

  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.

  From the completion of the manual till 4 months

Secondary Outcomes (9)

• Change in the Hospital Anxiety and Depression Scale (HADS)

  Baseline, 4 months follow up, 12 months follow up

• Metacognitions Questionnaire 30 (MCQ-30)

  Baseline, 4 months follow up, 12 months follow up

• Cognitive Attentional Syndrome Scale (CAS-1)

  Baseline, 4 months follow up, 12 months follow up

• Impact of Events Scale - Revised (IES-R)

  Baseline, 4 months follow up, 12 months follow up

• Health Related Quality of Life (EQ-5D)

  Baseline, 4 months follow up, 12 months follow up

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

ACTIVE COMPARATOR

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-MCT)

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• Greater Manchester Mental Health NHS Foundation Trust: collaborator
• University of Liverpool: collaborator

Study Sites (2)

Bolton NHS Foundation Trust

Bolton, United Kingdom

Location

Aintree Liverpool NHS Foundation Trust

Liverpool, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 35467904 RESULT

• 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.

  PMID: 35722590 DERIVED

• 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.

  PMID: 30115112 DERIVED

Related Links

• Web-site with details about the study

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Adrian Wells, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 26, 2017
• Study Start: April 4, 2017
• Primary Completion: June 20, 2018
• Study Completion: March 14, 2019
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

GB (2)