Implementing Group Metacognitive Therapy in Cardiac Rehabilitation

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05956912
Study type	Observational [Patient Registry]
Source	University of Manchester
Contact	Adrian Wells, PhD
Phone	01612765399
Email	adrian.wells@manchester.ac.uk
Status	Recruiting
Phase
Start date	September 6, 2022
Completion date	August 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms