Clinical trial NCT02420431: Treating Depression and Anxiety in the Cardiac Rehabilitation 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Cardiac Rehabilitation
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Manchester Mental Health & Social Care Trust
name: University of Liverpool
First posted: 2015-04-17
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline pre treatment, four-month post baseline
Secondary outcomes:
measure: Impact of Events Scale -revised
timeFrame: Baseline, four-month post baseline, 12 months follow-up
measure: Metacognitions Questionnaire 30
timeFrame: Baseline, four-month post baseline, 12 month follow-up
measure: Cognitive Attentional Syndrome scale (CAS-1)
timeFrame: Baseline, four-month post baseline, 12 months follow-up
measure: Health Related Quality of Life (EQ-5D)
timeFrame: Baseline, four-month post baseline, 12 months follow-up
measure: Economic Patient Questionnaire
timeFrame: Baseline, 4 month follow-up, 12 months follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: Cheshire
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
state: Lancashire
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust
state: Lancashire
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: Stepping Hill Hospital
Study officials:
affiliation: University of Manchester
name: Adrian Wells, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.