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NCT03999359
A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)
NA trial testing Home-based Metacognitive Therapy in Depression in 242 participants. Terminated before completion.
7 August 2020
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 242 |
| Start date | 14 May 2019 |
| Primary completion | 7 August 2020 |
| Estimated completion | 7 August 2020 |
| Sites | 5 locations across United Kingdom |
Drugs / interventions tested
- Home-based Metacognitive Therapy
Conditions studied
- Depression — all drugs for Depression →
- Anxiety — all drugs for Anxiety →
- Cardiac Rehabilitation — all drugs for Cardiac Rehabilitation →
- Psychological Distress — all drugs for Psychological Distress →
Sponsor
University of Manchester
Who can join
18 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 self-help 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 evaluate the effectiveness and cost-effectiveness of Home-MCT.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.
Wells A, Reeves D, Heal C, Fisher P, et al · · 2023 · cited 12× · PMID 36719886 · DOI 10.1371/journal.pmed.1004161 -
Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme.
Wells A, Reeves D, Heal C, Davies LM, et al · · 2022 · cited 12× · PMID 35722590 · DOI 10.3389/fpsyt.2022.886407 -
Metacognitive therapy self-help for anxiety-depression: Single-blind randomized feasibility trial in cardiovascular disease.
Wells A, Reeves D, Heal C, Fisher P, et al · · 2022 · cited 7× · PMID 35467904 · DOI 10.1037/hea0001168 -
Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in Cardiac Rehabilitation: The PATHWAY Research Programme Including 4 RCTs
Wells A, Reeves D, Fisher P, Davies L, et al · · 2024 · PMID 39353053
Verify or expand the search:
- PubMed search for NCT03999359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03999359 (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: 22 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03999359.
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