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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956912
• Other study ID #: IRAS ID: 313677
• Secondary ID: 29567
• Status: Recruiting
• Start date: September 6, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2023
• Source: University of Manchester
• Contact: Adrian Wells, PhD
• Phone: 01612765399
• Email: adrian.wells[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Qualitative Inclusion Criteria:

All CR staff must meet the following inclusion criteria to be eligible:

1. Be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-MCT

2. Be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level

3. Minimum of 18 years old

4. Competent level of English Language skills (able to read, understand and complete interviews in English).

Exclusion Criteria:

1. Below 18 years of age

2. Not a healthcare professional or professional working at the commissioner level

3. Does not have a competent level of English language skills

Audit inclusion criteria:

All patients attending CR who meet the NICE recommendations for acute coronary syndrome (NG185) and heart failure (NG106) will be offered group MCT as part of routine CR.

Related Conditions & MeSH terms

• Anxiety
• Cardiac Rehabilitation
• Depression

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (4)

Lead Sponsor	Collaborator
University of Manchester	Greater Manchester Mental Health NHS Foundation Trust, National Institute for Health Research, United Kingdom, University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of group MCT	Successful adoption of group MCT at each site is set a-priori. A traffic-light criteria will be used to determine successful adoption.; Green - achieved all of the following: a) Delivered two 6-session group MCT courses (b) at least three patients per group, and (c) a combined total of at least 60% attending four or more sessions.; Amber - achieved one of the three criteria given above.; Red - achieved none of the criteria.; A Green rating indicates that a site has fully met the criteria for successful adoption. Red indicates a failure to meet the requirements. Amber is partial adoption, where amendments to procedures and protocols might lead to successful adoption. At Amber sites, specific qualitative work will be undertaken to understand the reasons for not meeting criteria more fully and to help develop strategies to ameliorate this. An overall assessment will be made considering the traffic-light ratings of all six beacon sites.	Within the 6 months that MCT is being delivered in CR services
Secondary	Dartmouth Coop	The COOP will be captured through the National Audit for Cardiac Rehabilitation. It is a self-report measure designed to evaluate the functional abilities of medical patients. It consists of nine items covering various areas such as physical function, daily activities, pain, social activities, social support, emotions, overall health, changes in health, and quality of life. Each chart includes text and illustrations to assist the user in responding. The responses are graded on an ordinal scale of 1 to 5, with one being the best score.	Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)
Secondary	Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)	To understand what CR staff views of training in group MCT are with a view to understanding enablers and barriers. To understand the consequences, both expected and unexpected, of implementing group-MCT, for example on existing CR services, staffing needs, administration and resource requirements.	1 month prior to training in MCT
Secondary	Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)	To understand what CR staff views of training in group MCT are with a view to understanding enablers and barriers. To understand the consequences, both expected and unexpected, of implementing group-MCT, for example on existing CR services, staffing needs, administration and resource requirements.	Within 1 month of delivering the pilot group of MCT
Secondary	Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)	To understand what CR staff views of training in group MCT are with a view to understanding enablers and barriers. To understand the consequences, both expected and unexpected, of implementing group-MCT, for example on existing CR services, staffing needs, administration and resource requirements.	Upon completion of delivering group-MCT, approximately 5 months after starting the delivery of MCT in CR
Secondary	Semi-structured interviews will explore the views and opinions of group-MCT in CR (CCG and other management stakeholders)	To understand the acceptability and feasibility of roll-out at commissioner level and what the enablers or barriers are. To understand the consequences, both expected and unexpected, of implementing group-MCT, for example on existing CR services, staffing needs, administration and resource requirements.	Through implementation of MCT in CR services, approximately 7 months.
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS will be captured through the National Audit for Cardiac Rehabilitation. It is a 14-item self-report questionnaire that measures symptoms of anxiety (7 items) and depression (7 items). Items are rated using a 4-point (0-3) scale, with higher scores indicating elevated distress. Scores for each subscale range from 0 to 21 and can be categorised as normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).	Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)

External Links

•   Research Project Website Page