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Completed

NCT Number: NCT02420431

Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiac Rehabilitation Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macclesfield District General Hospital, Macclesfield, Cheshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metacognitive Therapy

Behavioral

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

Cardiac Rehabilitation (treatment as usual)

Behavioral

Stress management, relaxation training, exercise and dietary advice.

Primary outcomes

  1. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline pre treatment, four-month post baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PATHWAY

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2015
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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