Additional information

Acknowledgements

We would first like to thank all of our patients who took part in the trial. Thank you for your time and dedication to the project, without which this study would not have been possible. We would also like to thank the PATHWAY research assistants, Dr Rebecca McPhillips, Ms Helen Morley, Dr Hannah Gaffney, Ms Rebecca Anderson, Dr Cintia Faija, Mr Avinash Atwal, Ms Zara Husain and Ms Bethany Cooper, and PATHWAY administrator Wendy Clarke, who contributed to patient recruitment and study organisation. We would like to thank Professor Bob Lewin for his contributions to the PATHWAY design. We would like to thank Dr Peter Salmon for his contribution to the qualitative aspects of the PATHWAY trial. We would like to thank Dr Stuart Wright for his contribution to the stated preference research. We would like to thank Dr Elizabeth Camacho for her contribution to the economic evaluation work. We would also like to thank Dr Kirsten McNicoll for assisting in grant preparation. We are most grateful for and thank the members of the Trial Steering Committee chaired by Professor Kate Jolly and including Professor Gill Lancaster, Professor Gerry Humphris and Mr Chris Houston. We would also like to thank our patient and public involvement group who advised throughout the entirety of the project: Christine Barker, Jerry Benjamin, Stephen Clegg, Jim Collins, Chris Cooper and Marie Holmes.

Contributions of authors

Adrian Wells (https://orcid.org/0000-0001-7713-1592). Professor of Clinical & Experimental Psychopathology. Conceived the study and obtained CLAHRC funding to develop the initial grant proposal and assemble the team; designed the study programme and obtained the funding; had overall responsibility for grant development and programme implementation; developed the MCT interventions, wrote the treatment manuals and clinically trained staff in delivering MCT; designed the study programme.

David Reeves (https://orcid.org/0000-0001-6377-6859). Professor of Biostatistics. Contributed to and oversaw the methodological and statistical design of the trials and contributed to study design, was responsible for the analysis of the feasibility trials and RCTs, and designed the study programme and obtained the study funding.

Peter Fisher (https://orcid.org/0000-0002-7388-720X). Reader in Clinical Psychology. Supported the qualitative methodology, analysis and dissemination and designed the study programme and obtained the study funding.

Linda Davies (https://orcid.org/0000-0001-8801-3559). Professor of Health Economics. Contributed to the health economics study design, conducted the health economic evaluation, and designed the study programme and obtained the study funding.

Gemma Shields (https://orcid.org/0000-0003-4869-7524). Lecturer in Health Economics. Conducted the health economic evaluation.

Patrick Joseph Doherty (https://orcid.org/0000-0002-1887-0237). Professor of Cardiovascular Health. Consulted on the structure of CR and supported study dissemination.

Anthony Heagerty (https://orcid.org/0000-0002-9043-2119). Professor of Medicine. Provided medical oversight and supported study dissemination.

Calvin Heal (https://orcid.org/0000-0002-6445-1551). Research Fellow. Was responsible for the analysis of the feasibility trials and RCTs.

Lindsey Brown (https://orcid.org/0009-0004-7332-1320). PPI Contributor. Provided PPI oversight and input.

Lora Capobianco (https://orcid.org/0000-0001-6877-8650). Senior Research Fellow. Contributed to the management of the study, data collection and report writing and co-ordinated PPI contributions to the studies.

Adrian Wells and Lora Capobianco compiled the first draft of this report with contributions from David Reeves, Calvin Heal, Peter Fisher, Gemma Shields, Lindsey Brown and Linda Davies.

All named authors reviewed and commented on drafts of the report. Investigators making specific contributions are listed in Acknowledgements.

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/TMJA2644.

Primary conflicts of interest: Adrian Wells is chief investigator of the current research funded by the National Institute for Health Research (NIHR) (RP-PG-1211-20011). Adrian Wells is the originator of metacognitive therapy and director of the Metacognitive Therapy Institute. Adrian Wells received funding as chief investigator for a subsequent study, ‘Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services’ (PATHWAY-Beacons; NIHR29567), and is chief investigator on projects NIHR201495 and NIHR35997 and co-chief investigator on project NIHR203634. David Reeves was a co-investigator and received funding from the NIHR Programme Grants for Applied Research (PGfAR) programme for a subsequent study ‘Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services’ (PATHWAY-Beacons; reference number 29567).

Linda Davies reports grants from NIHR (NIHR132269, NIHR200460, RP-PG-0218-20006, 17/80/09, 16/167/76, 17/31/05) and Trial Steering Committee/Data Monitoring Committee membership for various NIHR studies (16/111/91; 16/116/82). Linda Davies also reports membership of advisory boards for Public Health England and is a member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Committee (2010–14). Linda Davies has been a member of a core group of methodological experts for the NIHR PGfAR programme (2011–15). Linda Davies also reports membership of the editorial board for BMC Psychiatry. Gemma Shields is co-investigator for other NIHR studies (NIHR134702, NIHR132690, NIHR201495, NIHR132622, NIHR203300, NIHR201482, NIHR203474, NIHR203507, NIHR132269, NIHR201093) unrelated to the MCT Pathway programme of work. Lora Capobianco is a co-chief investigator for the NIHR study NIHR203634 and a co-investigator for the following NIHR studies: NIHR29567, NIHR201495 and NIHR35997.

The NIHR PGfAR programme funded the work that this manuscript reports and a subsequent (ongoing) study to evaluate the implementation of group-metacognitive therapy within cardiac rehabilitation services.

Patient data statement

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Ethics statement

Work stream 1 (WS1) was approved by the National Research Ethics Service of the UK’s NHS (reference 15/NW/0163) and registered with a clinical trial database (ISRCTN74643496). Ethical approval was sought from NRES Committee North West REC reference (15/NW/0163) for associated qualitative work.

Work stream 2 (WS2) was obtained from the Preston Research Ethics Committee (REC Reference 15/NW/0163) along with site-specific approval. The trial is registered with the ISCRTN registry, No. ISRCTN74643496. Associated Qualitative work received ethical approval from NRES Committee Northwest REC reference (15/NW/0163) on 6 March 2015.

Work stream 3 (WS3) received full ethical approval from the Northwest – Greater Manchester West Research Ethics Committee (Reference 16/NW/0786, IRAS ID 186990) and was registered with a clinical trials database (NCT03129282) on 11 Nov 2016.

Work stream 3+ (WS3+) obtained ethical approval from the Northwest – Greater Manchester West Research Ethics Committee (REC Reference 16/NW/0786) on 03 January 2017, along with site-specific approval.

Information governance statement

Greater Manchester Mental Health NHS Foundation Trust is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, Greater Manchester Mental Health NHS Foundation Trust is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here (https://www.gmmh.nhs.uk/gdpr-in-research)

Department of Health and Social Care disclaimer

This publication presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by the interviewees in this publication are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, MRC, NIHR Coordinating Centre, the PGfAR programme or the Department of Health and Social Care.

This monograph was published based on current knowledge at the time and date of publication. NIHR is committed to being inclusive and will continually monitor best practice and guidance in relation to terminology and language to ensure that we remain relevant to our stakeholders.

Publications

Articles

1. Wells A, Faija C. Metacognitive Therapy for anxiety and depression in cardiac rehabilitation: commentary on the UK National Institute of Health Research funded PATHWAY programme. J Cardiol Cardiovasc Sci 2018;2:10–14. https://doi.org/10.29245/2578-3025/2018/3.1131
2. Wells A, McNicol K, Reeves D, Salmon P, Davies L, Heagerty A, et al. 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;19. https://doi.org/10.1186/s13063-018-2826-x
3. Shields G, Wells A, Doherty P, Heagerty A, Buck D, Davies L. Cost-effectiveness of cardiac rehabilitation: a systematic review. Heart 2018;104:1403–10. https://doi.org/10.1136/heartjnl-2017-312809
4. Wells A, McNicol K, Reeves D, Salmon P, Davies L, Heagerty A, et al. Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial. Trials 2018;19. https://doi.org/10.1186/s13063-018-2593-8
5. McPhillips R, Salmon P, Wells A, Fisher P. Cardiac rehabilitation patients’ accounts of their emotional distress and psychological needs: a qualitative study. J Am Heart Assoc 2019;8. https://doi.org/10.1161/JAHA.118.011117
6. McPhillips R, Salmon P, Wells A, Fisher P. Qualitative analysis of emotional distress in cardiac patients from the perspectives of cognitive behavioral and metacognitive theories: why might cognitive behavioral therapy have limited benefit, and might metacognitive therapy be more effective? Front Psychol 2019;9. https://doi.org/10.3389/fpsyg.2018.02288
7. Faija C, Reeves D, Heal C, Capobianco L, Anderson R, Wells A. Measuring the cognitive attentional syndrome in cardiac patients with anxiety and depression symptoms: psychometric properties of the CAS-1R. Front Psychol 2019;10. https://doi.org/10.3389/fpsyg.2019.02109
8. Anderson R, Capobianco L, Fisher P, Reeves D, Heal C, Faija C, et al. Testing relationships between metacognitive beliefs, anxiety, and depression in cardiac and cancer patients: are they transdiagnostic? J Psychosom Res 2019;124:109738. https://doi.org/10.1016/j.jpsychores.2019.109738
9. Shields G, Wells A, Doherty P, Reeves D, Capobianco L, Heagerty A, et al. Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression. BMJ Open 2020;10:e035552. https://doi.org/10.1136/bmjopen-2019-035552.
10. Wells A, Reeves D, Heal C, Fisher P, Davies L, Heagerty A, et al. Establishing the feasibility of group metacognitive therapy for anxiety and depression in cardiac rehabilitation: a single-blind randomized pilot study. Front Psychiatry 2020;11. https://doi.org/10.3389/fpsyt.2020.00582
11. Faija C, Reeves D, Heal C, Wells A. Metacognition in cardiac patients with anxiety and depression: psychometric performance of the metacognitions questionnaire 30 (MCQ-30). Front Psychol 2020;11. https://doi.org/10.3389/fpsyg.2020.01064
12. Shields G, Brown L, Wells A, Capobianco L, Vass C. Utilising patient and public involvement in stated preference research in health: learning from the existing literature and a case study. The Patient – Patient-Centered Outcomes Research 2020;14:399–412. https://doi.org/10.1007/s40271-020-00439-2
13. Capobianco L, Faija C, Husain Z, Wells A. Metacognitive beliefs and their relationship with anxiety and depression in physical illnesses: a systematic review. PLOS ONE 2020;15:e0238457. https://doi.org/10.1371/journal.pone.0238457
14. Shields G, Wright S, Wells A, Doherty P, Capobianco L, Davies L. Delivery preferences for psychological intervention in cardiac rehabilitation: a pilot discrete choice experiment. Open Heart 2021;8:e001747. https://doi.org/10.1136/openhrt-2021-001747
15. McPhillips R, Capobianco L, Cooper B, Husain Z, Wells A. Cardiac rehabilitation patients experiences and understanding of group metacognitive therapy: a qualitative study. Open Heart 2021;8:e001708. https://doi.org/10.1136/openhrt-2021-001708
16. Wells A, Reeves D, Capobianco L, Heal C, Davies L, Heagerty A et al. Improving the effectiveness of psychological interventions for depression and anxiety in cardiac rehabilitation: PATHWAY – a single-blind, parallel, randomized, controlled trial of group metacognitive therapy. Circulation 2021;144:23–33. https://doi.org/10.1161/CIRCULATIONAHA.120.052428
17. Wells A, Reeves D, Heal C, Davies LM, Shields GE, Hagerty A, et al. Evaluating metacognitive therapy to improve treatment of anxiety and depression in cardiovascular disease: the NIHR funded PATHWAY research programme. Front Psychiatry 2022;13:886407. https://doi.org/10.3389/fpsyt.2022.886407
18. Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, et al. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: a single-blind randomised controlled trial. PLOS Med 2023;20:e1004161. https://doi.org/10.1371/journal.pmed.100416

Conference abstracts

1. Anderson R, Fisher P, Gaffney H, Morley H, Wells A. Are Metacognitive Beliefs Transdiagnostic: A Comparison of Cancer and Cardiac Patients Experiencing Anxiety and Depression. The 3rd International Conference of Metacognitive Therapy, 8–9 April 2016, Milan, Italy, symposium 9, abstract 2.
2. Atwal A, Capobianco L, Wells A. Project Management in Clinical Research: A Case Study of the MCT PATHWAY Trial. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, poster 6.
3. Capobianco L, Faija C, Wells A. Metacognitive Beliefs in Physical Illnesses: A Systematic Review and Meta-Analysis. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 1, abstract 1.
4. Cooper B, Capobianco L, Heal C, Doherty P, Wells A. Exploring Sociodemographic and Psychological Predictors of Attendance at Cardiac Rehabilitation. British Association for Cardiovascular Prevention and Rehabilitation Conference, virtual/online, October 2021.
5. Faija C, Reeves D, Heal C, Wells A. Assessing Metacognitions in Cardiac Patients with Co-Morbid Anxiety and/or Depression. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 1, abstract 2.
6. Faija C, Reeves D, Heal C, Capobianco L, Anderson R, Wells A. The Cognitive Attentional Syndrome in Cardiac Patients Experiencing Anxiety and/or Depression. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, poster 1.
7. Gaffney H, Anderson R, Morley H, Shields G, Fisher P, Salmon P, et al. Key Considerations in the Development, Implementation and Evaluation of a Metacognitive Therapy Intervention for Anxiety and Depression in the Cardiac Rehabilitation Pathway: The PATHWAY Trial. The 3rd International Conference of Metacognitive Therapy, 8–9 April 2016, Milan, Italy, symposium 9, abstract 3.
8. Husain Z, Capobianco L, Brown L, Wells A. Patient and Public Involvement within the MCT Cardiac Rehabilitation Pathway. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, poster 5.
9. McPhillips R, Fisher P, Salmon P, Wells A. Cardiac Rehabilitation Patients’ Views, and Experience of Group Metacognitive Therapy: A Nested Longitudinal Study. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 2, abstract 1.
10. McPhillips R, Fisher P, Salmon P, Wells A. Cardiac Rehabilitation Practitioners’ Views and Experiences of Being Trained in, and Delivering, Group Metacognitive Therapy: A Nested Longitudinal Study. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 2, abstract 2.
11. McPhillips R, Salmon P, Fisher P, Wells A. Integrating Group-Metacognitive Therapy into Cardiac Rehabilitation Pathways: Practitioner Perspectives. The 3rd International Conference of Metacognitive Therapy, 8–9 April 2016, Milan, Italy, symposium 10, abstract 7.
12. McPhillips R, Salmon P, Wells A, Fisher P. ‘It’s kind of like, life changing for me’: A Qualitative Investigation of Cardiac Patients’ Experiences of Group-Metacognitive Therapy as Part of The PATHWAY Trial. The 3rd International Conference of Metacognitive Therapy, 8–9 April 2016, Milan, Italy, symposium 9, abstract 1.
13. McPhillips R, Salmon P, Wells A, Fisher P. The Psychological Needs of Emotionally Distressed Cardiac Rehabilitation Patients: A Qualitative Study of How Well Cardiac Rehabilitation Addresses Them. British Association for Cardiovascular Prevention and Rehabilitation Conference. Cardiff, UK, October 2016.
14. Shields GE, Davies LM, Doherty P, Reeves D, Capobianco L, Heagerty A, et al. Exploring the Costs and Cost-Effectiveness of Metacognitive Therapy for Cardiac Rehabilitation Patients with Symptoms of Anxiety and/or Depression. British Association for Cardiovascular Prevention and Rehabilitation Conference, virtual/online, October 2021.
15. Shields GE, Davies LM, Doherty P, Capobianco L, Buck D, Wells A. Attendance at Cardiac Rehabilitation Sessions in a Group with Symptoms of Anxiety and/or Depression. Health Services Research UK, virtual/online, July 2020.
16. Shields GE, Wells A, Capobianco L, Davies LM. Factors Associated with Symptoms of Depression and/or Anxiety, Health Status and Metacognitive Beliefs in a Population Undergoing Cardiac Rehabilitation. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 1, abstract 3.
17. Shields GE, Wells A, Capobianco L, Davies LM. Costing Metacognitive Therapy in the UK. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, symposium 2, abstract 3.
18. Shields GE, Wells A, Capobianco L, Davies LM. Patient and Public Involvement: Feedback on Important Characteristics of MCT Therapy Included in the Cardiac Rehabilitation Pathway. 4th International Conference of Metacognitive Therapy, 30 April–2 May 2019, Prague, Czechia, poster 3.
19. Shields GE, Buck D, Wells A, Doherty P, Heagerty T Davies LM. A Systematic Literature Review of the Cost-effectiveness of Cardiac Rehabilitation Interventions. British Association for Cardiovascular Prevention and Rehabilitation Conference. Cardiff, UK, October 2016.
20. Wells A, Reeves D, Capobianco L, Heal C, Davies L, Heagerty A, et al. Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in Cardiac Rehabilitation: PATHWAY – A Single Blind, Parallel, Randomized, Controlled Trial of Group Metacognitive Therapy. British Association for Cardiovascular Prevention and Rehabilitation Conference, virtual/online, October 2021.
21. Wells A, Reeves D, Fisher P, Heal C, Davies L, Heagerty A, et al. Home-based Metacognitive Therapy for Anxiety and Depression: A Single Blind Randomised Feasibility Trial of Assisted Self-help in Patients with Cardiovascular Disease. British Association for Cardiovascular Prevention and Rehabilitation Conference, virtual/online, October 2021.

Blog posts and newsletters

1. Barker C. Me, my heart, my mind. ADePT-RU News, 2021. URL: https://adept-ru.com/me-my-heart-my-mind/ (accessed 14 July 2021).
2. Brown L. The PPI balance: benefits to research and those who take part. ADePT-RU News, 2021. URL: https://adept-ru.com/the-ppi-balance-benefits-to-research-and-those-who-take-part/ (accessed 10 August 2021).
3. Franklin S. Patient and Public Involvement in Stated Preference Research in Health. BMH Patient and Public Involvement and Engagement; 2020. URL: https://blogs.manchester.ac.uk/bmh-ppie/2020/12/01/patient-and-public-involvement-in-stated-preference-research-in-health/ (accessed 1 December 2020).
4. Manchester Centre for Health Economics. Metacognitive Therapy in Cardiac Rehabilitation. Newsletter, autumn 2021. Manchester: University of Manchester; 2021, p. 3.
5. The Ticker Club. Pathway: Taking Part in Cardiac Research. Newsletter, autumn 2021. Manchester: The Ticker Club; 2021, p. 4.

Community engagement

1. ‘The PATHWAY Study Results Event’, delivered on Microsoft Teams. 15 July 2021.
2. ‘Improving the effectiveness of psychological interventions for anxiety and depression in cardiac rehabilitation’ interactive presentation delivered at the Ticker Club Annual Patient Support Visitors’ Seminar. 25 June 2019.
3. ‘Sharing perspectives; PPI in the MCT PATHWAY Trial’ presentation delivered at Greater Manchester Mental Health Trust, Climbing the Ladder of Co–Production: The Involvement of Service Users and Carers in Clinical Research event for service users and staff. 17 May 2019.
4. Research and Innovation (R&I) Staff Engagement Event: Equality and Diversity, ‘Accessibility and disability in research – not every disability is visible’. 18 May 2018.
5. Holy Cross College Presentation. 2016. Two senior research assistants from the PATHWAY programme attended a Sixth Form Careers Day at Holy Cross College, Bury, to talk about the PATHWAY programme, their roles as senior research assistants, and their careers in psychology to date. The PATHWAY staff gave a short presentation, following which they answered questions and later spoke with students in more detail at a lunchtime event. Staff from the college reported that students enjoyed learning about how research in psychology is done in practice, and that this had encouraged students to consider different careers in psychology.

Disclaimers

This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.