Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway: a single-blind randomised controlled trial
| ISRCTN | ISRCTN74643496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74643496 |
| ClinicalTrials.gov number | NCT02420431 |
| Secondary identifying numbers | 18718 |
- Submission date
- 08/04/2015
- Registration date
- 08/04/2015
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Depression and anxiety are common among cardiac rehabilitation (CR) patient populations with 37% of patients experiencing significant anxiety and/or depression. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health in this population. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (treatment) called Metacognitive therapy has been shown to reduce this style of thinking and alleviate depression and anxiety. Evidence also shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. Metacognitive Therapy (MCT), a psychological intervention, has been shown to reduce this style of thinking and to alleviate depression and anxiety in mental health settings. The PATHWAY study aims to integrate a group metacognitive therapy intervention (Group-MCT) into current CR services. The intervention will lead to better informed and integrated care with the potential to improve psychological and physical wellbeing as well as reduce NHS costs.
Who can participate?
Adults patients (aged at least 18) referred to CR and experiencing anxiety and/or depression.
What does the study involve?
The programme is undertaken at three NHS trusts. Initially, a pilot trial of the Group-MCT intervention is run to test whether adding the Group-MCT intervention to standard CR works better at alleviating anxiety and depression than standard CR alone. We then run a full-scale trial of the Group-MCT intervention. Participants are randomly assigned to either intervention or control conditions. Patients in the intervention condition are given six sessions of Group-MCT which are integrated into the CR pathway programme. The intervention is given by trained health professionals. Health professionals are trained in delivering Group-MCT by Professor Adrian Wells (the originator of MCT) and by Dr Peter Fisher. The control condition receive care as usual along the CR pathway. Each participants anxiety and depression levels are measured at four and 12 month after treatment. Participants taking part in the pilot study are also interviewed before treatment starts, during the treatment and then after treatment. We also seek to interview patients who decline the intervention or drop-out, in addition to control patients. We will include the patients’ principal carer in interviews if the patient wishes.
What are the possible benefits and risks of participating?
The information we gather from this study will help to inform care on the cardiac rehabilitation pathway for future patients. The group metacognitive therapy sessions are designed to help in managing distress so patients may benefit from receiving this therapy as part of their usual care. It is possible that talking about their difficulties that this may cause some distress to patients. However, the group metacognitive therapy sessions are designed to aid patients in managing their feelings better.
Where is the study run from?
Hospitals from the University Hospital of South Manchester NHS Foundation Trust, Central Manchester University Hospitals NHS Foundation Trust, East Cheshire NHS Trust.
When is the study starting and how long is it expected to run for?
June 2015 to February 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Lora Capobianco, lora.capobianco@gmmh.nhs.uk
(updated 28/09/2021, previously: Dr Jane Garnett)
Contact information
Scientific
University of Manchester
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
| lora.capobianco@gmmh.nhs.uk |
Study information
| Study design | Randomized; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway: a single blind randomised controlled trial with four month and twelve month follow up comparing GroupMCT plus usual CR (intervention) with usual CR (control). |
| Study acronym | PATHWAY |
| Study objectives | The study aims to improve access to more effective psychological interventions for the range of heart disease patients attending cardiac rehabilitation services. The principle research question is: Does the addition of group metacognitive therapy to treatment as usual improve psychological outcomes (distress) more than treatment as usual alone. |
| Ethics approval(s) | NRES committee North West – Preston, ref: 15/NW/0163 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | 1. Experimental: metacognitive therapy plus CR Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation). Metacognitive therapy (MCT) helps clients to identify episodes of worry and rumination in response to negative thoughts and bring these responses under control. This process is facilitated by exercises that enhance the flexibility of attention control, challenge unhelpful beliefs about thinking and enable new relationships with thoughts 2. Active Comparator: Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education. |
| Intervention type | Other |
| Primary outcome measure | Change in Hospital Anxiety and Depression Scale (HADS) [Time Frame: Baseline pre treatment, four-month post baseline, 12 months follow-up] |
| Secondary outcome measures | 1. Metacognitions Questionnaire 2. Cognitive Attentional Syndrome 3. Impact of Event Scale-Revised 4. Health Related Quality of Life 5. Economic Patient Questionnaire (EPQ) |
| Overall study start date | 01/06/2015 |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 332; UK Sample Size: 332 |
| Total final enrolment | 332 |
| Key inclusion criteria | 1. Heart disease patients referred to CR who meet DoH and/or BACPR CR eligibility criteria 2. Minimum of 18 years old 3. Competent level of English language skills (able to read, understand and complete questionnaires in English). 4. Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart 5. Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia 6. Stable heart failure 7. Stable angina is chest pain or discomfort that most often occurs with activity or stress 8. Following implantation of cardioverter defibrillators/cardiac resynchronisation devices 9. Heart valve repair/replacement 10. Heart transplantation and ventricular assist devices 11. Adult congenital heart disease identified in adulthood 12. A score of = 8 on either the depression or anxiety subscale of the HADS. |
| Key exclusion criteria | 1. Cognitive impairment which precludes informed consent or ability to participate 2. Acute suicidality 3. Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms) 4. Current drug/alcohol abuse a maladaptive pattern of drinking, leading to clinically significant impairment or distress 5. Concurrent psychological intervention for emotional distress 6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks 7. Life expectancy of less than 12 months |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
M13 9WL
United Kingdom
M23 9LT
United Kingdom
M13 9WU
United Kingdom
-
United Kingdom
Sponsor information
Hospital/treatment centre
Rawnsley Building, Manchester Royal Infirmary , Oxford Road
Manchester
M13 9WL
England
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A dissemination/impact plan will be devised at study outset and will be updated and delivered throughout the programme and beyond. Its focus will be to maximise the reach and impact of the outputs and will be monitored by a dissemination group chaired by the PI which will meet six-monthly. The group will also lead development of information for patients and the public in collaboration with the service user advisers. We will have a programme website with up-to-date information available in an accessible format for online reading/download. Dr Williamson, the programme PPI expert, will be closely involved in this work to ensure it is developed with input from the user advisers and made fit-for-purpose. We will capitalise on Salford University’s relationship with Media City to exploit findings using its media expertise and state-of-the-art facilities: (http://www.mediacityuk.co.uk/ourcommunity/occupiers/ university-of-salford). In the final year, an online resource will be developed for stakeholders which summarises the programme and key findings. With permission from the funder, a full and summary final report will be made available in paper and online versions. These will use plain language wherever possible and will be developed with input from user advisers. A separate report on the impact of PPI in the programme will also be produced. We have allocated monies for dissemination in each year of the programme. We will present findings at clinical academic cardiovascular and psychological therapies conferences (e.g. BACPR, EACPR, European Association for Behavioural and Cognitive Therapies), and public involvement conferences (e.g. INVOLVE). Smaller local dissemination opportunities such as regional conferences/forums will be presented at to maximise knowledge transfer to a wide range of stakeholders (e.g. Good Practice Days at local NHS trusts). |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/09/2020 | 15/09/2020 | Yes | No |
| Protocol article | protocol | 03/04/2018 | 11/02/2021 | Yes | No |
| Results article | 06/07/2021 | 28/09/2021 | Yes | No | |
| Results article | 03/06/2022 | 21/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | internal pilot acceptability and feasibility study | 30/06/2020 | 09/07/2024 | Yes | No |
| Other publications | Economic evaluation | 20/12/2024 | 20/01/2025 | Yes | No |
Editorial Notes
20/01/2025: Publication reference added.
09/07/2024: Publication reference added.
21/06/2022: Publication reference added.
28/09/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The trial website was added.
3. The contact was changed.
4. The plain English summary was updated to reflect these changes.
05/03/2021: The following changes have been made:
1. The target number of participants has been changed from "Planned Sample Size: 350; UK Sample Size: 350" to "Planned Sample Size: 332; UK Sample Size: 332" and the total target enrolment changed from 350 to 332.
2. The intention to publish date has been changed from 31/08/2020 to 31/08/2021.
11/02/2021: Publication reference added.
15/09/2020: Publication reference added.
23/07/2019: The following changes were made to the trial record:
1. ClinicalTrials.gov number added.
2. The total final enrolment was added.
3. The overall end date was changed from 28/02/2018 to 31/08/2019.
4. The recruitment end date was changed from 28/02/2018 to 28/02/2019.
5. The intention to publish date was added.
