Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway

Depression Clinical Trial

— PATHWAY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420431
• Other study ID #: 156862 (RP-PG-1211-20011)
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 2019

Study information

• Verified date: March 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: August 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cardiac Rehabilitation
• Depression
• Depressive Disorder

Intervention

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
• Cardiac Rehabilitation (treatment as usual)
Stress management, relaxation training, exercise and dietary advice.

Locations

Country	Name	City	State
United Kingdom	Macclesfield District General Hospital	Macclesfield	Cheshire
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester	Lancashire
United Kingdom	Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	Stepping Hill Hospital	Manchester
United Kingdom	University Hospital of South Manchester NHS Foundation Trust	Manchester	Lancashire

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hospital Anxiety and Depression Scale (HADS)		Baseline pre treatment, four-month post baseline
Secondary	Impact of Events Scale -revised		Baseline, four-month post baseline, 12 months follow-up
Secondary	Metacognitions Questionnaire 30		Baseline, four-month post baseline, 12 month follow-up
Secondary	Cognitive Attentional Syndrome scale (CAS-1)		Baseline, four-month post baseline, 12 months follow-up
Secondary	Health Related Quality of Life (EQ-5D)		Baseline, four-month post baseline, 12 months follow-up
Secondary	Economic Patient Questionnaire		Baseline, 4 month follow-up, 12 months follow-up
Secondary	Hospital Anxiety and Depression Scale		12 month follow-up