Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)

NCT ID: NCT05956912

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-08-31

Brief Summary

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Background: Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients, and current psychological treatments for cardiac patients have minor effects. However, the NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. Group MCT was also associated with preventing anxiety and depression. The next steps will establish beacon sites for delivering MCT and pilot-test additions to the national audit of cardiac rehabilitation (NACR) data capture mechanism to include an MCT data field. Such steps will support a quantitative and qualitative evaluation of implementation.

Methods: The investigators aim to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. The investigators will deliver training in group MCT to CR staff from CR services across England. The investigators will conduct semi-structured qualitative interviews with CR staff trained in group MCT to assess views on the training programme, including successes and barriers to implementation of training and delivery. The investigators will interview 8-10 CR stakeholders to identify any barriers to implementation and how these might be resolved.

Discussion: The study will support development of an NHS roll-out strategy and systematic data collection that can be used to evaluate wide-scale implementation. The study can benefit service users by improving patients' mental health outcomes and CR practitioners' clinical skills. Results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.

Detailed Description

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Conditions

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Anxiety Depression Cardiac Rehabilitation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-MCT
2. Be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level
3. Minimum of 18 years old
4. Competent level of English Language skills (able to read, understand and complete interviews in English).


All patients attending CR who meet the NICE recommendations for acute coronary syndrome (NG185) and heart failure (NG106) will be offered group MCT as part of routine CR.

Exclusion Criteria

1. Below 18 years of age
2. Not a healthcare professional or professional working at the commissioner level
3. Does not have a competent level of English language skills
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of York

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Adrian Wells

Professor of Clinical and Experimental Psychopathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Wells, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Adrian Wells, PhD

Role: CONTACT

01612765399

Lora Capobianco, PhD

Role: CONTACT

01610046664

Facility Contacts

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Lora Capobianco, PhD

Role: primary

References

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Wells A, Reeves D, Belcher A, Wilson P, Doherty P, Capobianco L. Protocol for an implementation study of group metacognitive therapy for anxiety and depression in NHS cardiac rehabilitation services in England (PATHWAY-Beacons). Front Health Serv. 2024 Oct 17;4:1296596. doi: 10.3389/frhs.2024.1296596. eCollection 2024.

Reference Type DERIVED
PMID: 39483442 (View on PubMed)

Related Links

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Other Identifiers

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29567

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRAS ID: 313677

Identifier Type: -

Identifier Source: org_study_id

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