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

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ClinicalTrials.gov Identifier: NCT02420431
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Manchester Mental Health & Social Care Trust
University of Liverpool
Information provided by (Responsible Party):
Adrian Wells, University of Manchester

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Cardiac Rehabilitation Behavioral: Metacognitive Therapy Behavioral: Cardiac Rehabilitation (treatment as usual) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline pre treatment, four-month post baseline ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420431


Contacts
Contact: Adrian Wells, Ph.D 00 44 161 2765399 adrian.wells@manchester.ac.uk
Contact: Rebecca McPhillips, PhD 00 44 161 2765380 rebecca.mcphillips@gmmh.nhs.uk

Locations
United Kingdom
Macclesfield District General Hospital Recruiting
Macclesfield, Cheshire, United Kingdom, SK10 3BL
Contact: Rebecca McPhillips, PhD       rebecca.mcphillips@gmmh.nhs.uk   
Central Manchester University Hospitals NHS Foundation Trust Recruiting
Manchester, Lancashire, United Kingdom, M13 9WL
Contact: Rebecca McPhillips, PhD       rebecca.mcphillips@gmmh.nhs.uk   
University Hospital of South Manchester NHS Foundation Trust Recruiting
Manchester, Lancashire, United Kingdom, M23 9LT
Contact: Rebecca McPhillips, PhD       rebecca.mcphillips@gmmh.nhs.uk   
Pennine Acute Hospitals NHS Trust Recruiting
Manchester, United Kingdom, M8 5RB
Contact: Rebecca McPhillips, PhD       rebecca.mcphillips@gmmh.nhs.uk   
Stepping Hill Hospital Recruiting
Manchester, United Kingdom, SK2 7JE
Contact: Rebecca McPhillips, PhD       rebecca.mcphillips@gmmh.nhs.uk   
Sponsors and Collaborators
University of Manchester
National Institute for Health Research, United Kingdom
Manchester Mental Health & Social Care Trust
University of Liverpool
Investigators
Principal Investigator: Adrian Wells, Ph.D University of Manchester

Responsible Party: Adrian Wells, Professor of Clinical and Experimental Psychopathology, University of Manchester
ClinicalTrials.gov Identifier: NCT02420431     History of Changes
Other Study ID Numbers: 156862 (RP-PG-1211-20011)
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders