Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway (PATHWAY)

March 20, 2023 updated by: Adrian Wells, University of Manchester

Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial

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 (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. The investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M8 5RB
        • Pennine Acute Hospitals NHS Trust
      • Manchester, United Kingdom, SK2 7JE
        • Stepping Hill Hospital
    • Cheshire
      • Macclesfield, Cheshire, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M23 9LT
        • University Hospital of South Manchester NHS Foundation Trust
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heart disease patients referred to CR with: Acute coronary syndrome
  • Following revascularisation; stable heart failure
  • Stable angina, implanted cardioverter defibrillators
  • Heart valve repair/replacement
  • Heart transplantation and ventricular assist devices
  • Adult congenital heart disease
  • Must have a score of 8 or more on either the depression or anxiety subscale of the HADS
  • Competent level of English language skills

Exclusion Criteria:

  • Cognitive impairment which precludes informed consent/ability to participate
  • Acute suicidality
  • Active psychotic disorders
  • Current drug/alcohol abuse
  • Concurrent psychological intervention for emotional distress
  • Antidepressant or anxiolytic medication initiated in previous 8 weeks
  • Life expectancy of less than 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Behavioral: Metacognitive Therapy
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
Active Comparator: CR alone (control)
Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education
Behavioral: Cardiac Rehabilitation (treatment as usual)
Stress management, relaxation training, exercise and dietary advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline pre treatment, four-month post baseline
Baseline pre treatment, four-month post baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of Events Scale -revised
Time Frame: Baseline, four-month post baseline, 12 months follow-up
Baseline, four-month post baseline, 12 months follow-up
Metacognitions Questionnaire 30
Time Frame: Baseline, four-month post baseline, 12 month follow-up
Baseline, four-month post baseline, 12 month follow-up
Cognitive Attentional Syndrome scale (CAS-1)
Time Frame: Baseline, four-month post baseline, 12 months follow-up
Baseline, four-month post baseline, 12 months follow-up
Health Related Quality of Life (EQ-5D)
Time Frame: Baseline, four-month post baseline, 12 months follow-up
Baseline, four-month post baseline, 12 months follow-up
Economic Patient Questionnaire
Time Frame: Baseline, 4 month follow-up, 12 months follow-up
Baseline, 4 month follow-up, 12 months follow-up
Hospital Anxiety and Depression Scale
Time Frame: 12 month follow-up
12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

University of Liverpool
National Institute for Health Research, United Kingdom
Manchester Mental Health & Social Care Trust

Investigators

  • Principal Investigator: Adrian Wells, Ph.D, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156862 (RP-PG-1211-20011)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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