Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway (PATHWAY)
Primary Purpose
Depression, Anxiety, Cardiac Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metacognitive Therapy
Cardiac Rehabilitation (treatment as usual)
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Macclesfield District General Hospital
- Central Manchester University Hospitals NHS Foundation Trust
- University Hospital of South Manchester NHS Foundation Trust
- Pennine Acute Hospitals NHS Trust
- Stepping Hill Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
metacognitive therapy plus CR
CR alone (control)
Arm Description
Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation)
Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education
Outcomes
Primary Outcome Measures
Change in Hospital Anxiety and Depression Scale (HADS)
Secondary Outcome Measures
Impact of Events Scale -revised
Metacognitions Questionnaire 30
Cognitive Attentional Syndrome scale (CAS-1)
Health Related Quality of Life (EQ-5D)
Economic Patient Questionnaire
Hospital Anxiety and Depression Scale
Full Information
NCT ID
NCT02420431
First Posted
April 9, 2015
Last Updated
March 20, 2023
Sponsor
University of Manchester
Collaborators
National Institute for Health Research, United Kingdom, Manchester Mental Health & Social Care Trust, University of Liverpool
1. Study Identification
Unique Protocol Identification Number
NCT02420431
Brief Title
Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway
Acronym
PATHWAY
Official Title
Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
National Institute for Health Research, United Kingdom, Manchester Mental Health & Social Care Trust, University of Liverpool
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Cardiac Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metacognitive therapy plus CR
Arm Type
Experimental
Arm Description
Group psychological treatment focused on reducing worry and rumination and modifying beliefs about thinking in addition to treatment as usual (standard cardiac rehabilitation)
Arm Title
CR alone (control)
Arm Type
Active Comparator
Arm Description
Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Rehabilitation (treatment as usual)
Intervention Description
Stress management, relaxation training, exercise and dietary advice.
Primary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline pre treatment, four-month post baseline
Secondary Outcome Measure Information:
Title
Impact of Events Scale -revised
Time Frame
Baseline, four-month post baseline, 12 months follow-up
Title
Metacognitions Questionnaire 30
Time Frame
Baseline, four-month post baseline, 12 month follow-up
Title
Cognitive Attentional Syndrome scale (CAS-1)
Time Frame
Baseline, four-month post baseline, 12 months follow-up
Title
Health Related Quality of Life (EQ-5D)
Time Frame
Baseline, four-month post baseline, 12 months follow-up
Title
Economic Patient Questionnaire
Time Frame
Baseline, 4 month follow-up, 12 months follow-up
Title
Hospital Anxiety and Depression Scale
Time Frame
12 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Wells, Ph.D
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macclesfield District General Hospital
City
Macclesfield
State/Province
Cheshire
ZIP/Postal Code
SK10 3BL
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Stepping Hill Hospital
City
Manchester
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34148379
Citation
Wells A, Reeves D, Capobianco L, Heal C, Davies L, Heagerty A, Doherty P, Fisher P. 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 Jul 6;144(1):23-33. doi: 10.1161/CIRCULATIONAHA.120.052428. Epub 2021 Jun 21.
Results Reference
result
PubMed Identifier
35722590
Citation
Wells A, Reeves D, Heal C, Davies LM, Shields GE, Heagerty A, Fisher P, Doherty P, Capobianco L. Evaluating Metacognitive Therapy to Improve Treatment of Anxiety and Depression in Cardiovascular Disease: The NIHR Funded PATHWAY Research Programme. Front Psychiatry. 2022 Jun 3;13:886407. doi: 10.3389/fpsyt.2022.886407. eCollection 2022.
Results Reference
derived
PubMed Identifier
31433708
Citation
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 Jun 4;8(11):e011117. doi: 10.1161/JAHA.118.011117. Epub 2019 Jun 1.
Results Reference
derived
Learn more about this trial
Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway
We'll reach out to this number within 24 hrs