NCT02420431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable depression

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

April 9, 2015

Last Update Submit

March 20, 2023

Conditions

DepressionAnxietyCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Hospital Anxiety and Depression Scale (HADS)

    Baseline pre treatment, four-month post baseline

Secondary Outcomes (6)

  • Impact of Events Scale -revised

    Baseline, four-month post baseline, 12 months follow-up

  • Metacognitions Questionnaire 30

    Baseline, four-month post baseline, 12 month follow-up

  • Cognitive Attentional Syndrome scale (CAS-1)

    Baseline, four-month post baseline, 12 months follow-up

  • Health Related Quality of Life (EQ-5D)

    Baseline, four-month post baseline, 12 months follow-up

  • Economic Patient Questionnaire

    Baseline, 4 month follow-up, 12 months follow-up

  • +1 more secondary outcomes

Study Arms (2)

metacognitive therapy plus CR

EXPERIMENTAL

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

CR alone (control)

ACTIVE COMPARATOR

Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education

Behavioral: Cardiac Rehabilitation (treatment as usual)

Interventions

Metacognitive TherapyBEHAVIORAL

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

metacognitive therapy plus CR
Cardiac Rehabilitation (treatment as usual)BEHAVIORAL

Stress management, relaxation training, exercise and dietary advice.

CR alone (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Macclesfield District General Hospital

Macclesfield, Cheshire, SK10 3BL, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, Lancashire, M13 9WL, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust

Manchester, Lancashire, M23 9LT, United Kingdom

Location

Pennine Acute Hospitals NHS Trust

Manchester, M8 5RB, United Kingdom

Location

Stepping Hill Hospital

Manchester, SK2 7JE, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 34148379RESULT

  • 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.

    PMID: 35722590DERIVED

  • 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.

    PMID: 31433708DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Cardiac RehabilitationTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Adrian Wells, Ph.D

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical and Experimental Psychopathology

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 17, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2019

Study Completion

August 1, 2019

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

GB(5)