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AnxietyNCT05956912

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

An observational study of Anxiety and Depression, run by University of Manchester at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Cardiac Rehabilitation
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
6 Sep 2022to 31 Aug 2023
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Cardiac rehabilitation staff trained in delivering Group-MCT, wider cardiac rehabilitation staff and managers, and healthcare professionals from local clinical commissioning groups. All CR patients attending cardiac rehabilitation.

Who may be able to join

None listed.

Who cannot join

  • Below 18 years of age
  • Not a healthcare professional or professional working at the commissioner level
  • 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.

Trial locations and contacts

1 site in 1 country.

Adrian Wells, PhD contact

01612765399

adrian.wells@manchester.ac.uk

Lora Capobianco, PhD contact

01610046664

lora.capobianco@gmmh.nhs.uk

United Kingdom1 site, 1 recruiting

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

    Lora Capobianco, PhD, Lora.capobianco@gmmh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

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.

Medical subject headings
Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    1. 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.
    2. Amber - achieved one of the three criteria given above.
    3. 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.

    Measured: Within the 6 months that MCT is being delivered in CR services

Secondary outcomes (6)

  1. 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.

    Measured: Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)

  2. 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.

    Measured: 1 month prior to training in MCT

  3. 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.

    Measured: Within 1 month of delivering the pilot group of MCT

  4. 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.

    Measured: Upon completion of delivering group-MCT, approximately 5 months after starting the delivery of MCT in CR

  5. 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.

    Measured: Through implementation of MCT in CR services, approximately 7 months.

  6. 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).

    Measured: Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study start6 Sep 2022
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05956912
Sponsor's protocol ID
IRAS ID: 313677
Other IDs
29567
Status last verified
Jul 2023
First submitted
9 May 2023
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wells A, Reeves D, Belcher A, Wilson P, Doherty P, Capobianco L. Protocol for an implementation study of group metacognitive therapy for anxiety and depression in NHS cardiac rehabilitation services in England (PATHWAY-Beacons). Front Health Serv. 2024 Oct 17;4:1296596. doi: 10.3389/frhs.2024.1296596. eCollection 2024.

    PubMed 39483442

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety and Depression, run by University of Manchester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adrian Wells, PhD (01612765399, adrian.wells@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption of group MCT (time frame: Within the 6 months that MCT is being delivered in CR services). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05956912, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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