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NCT05956912
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
trial in Anxiety in 100 participants. Status unknown.
31 August 2023
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 6 September 2022 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Anxiety — all drugs for Anxiety →
- Depression — all drugs for Depression →
- Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
Sponsor
University of Manchester
Who can join
18 and older, any sex, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Protocol for an implementation study of group metacognitive therapy for anxiety and depression in NHS cardiac rehabilitation services in England (PATHWAY-Beacons).
Wells A, Reeves D, Belcher A, Wilson P, et al · · 2024 · PMID 39483442 · DOI 10.3389/frhs.2024.1296596
Verify or expand the search:
- PubMed search for NCT05956912
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05956912 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 24 July 2023
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