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Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients

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ClinicalTrials.gov Identifier: NCT03129282
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Greater Manchester Mental Health NHS Foundation Trust
University of Liverpool
Information provided by (Responsible Party):
Adrian Wells, University of Manchester

Brief Summary:

Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.

Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.

This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.


Condition or disease Intervention/treatment Phase
Depression Anxiety Cardiac Rehabilitation Psychological Distress Other: Home-based Metacognitive Therapy (Home-MCT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Active Comparator: Intervention
Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)
Other: Home-based Metacognitive Therapy (Home-MCT)
Home-based metacognitive therapy (Home-MCT) is a facilitated self-help manual comprising six modules which participants will complete at their own pace over approximately 6 weeks. Participants will have an initial appointment with a Home-MCT trained cardiac rehabilitation staff members (face to face or by telephone). In addition, they will receive two telephone calls from trained cardiac rehabilitation staff members over the course of the intervention to offer support with completing the modules of the self-help manual.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: From the completion of the manual till 4 months ]
    Acceptability of the intervention is defined as the completion of the first 4 modules of the Home-MCT manual, which includes 6 modules in total. Acceptability will be expressed as a % of all patients randomised to the treatment arm, minus deaths. This will be compared to the % of controls (minus deaths) who complete the 4-month follow up.


Secondary Outcome Measures :
  1. Change in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The HADS is a 14-item self-report scale assessing anxiety and depression

  2. Metacognitions Questionnaire 30 (MCQ-30) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The MCQ-30 is a 30-item self-report scale that measures: a) Lack of Cognitive Confidence, b) Positive Beliefs about Worry, c) Cognitive Self-Consciousness, d) Negative Beliefs about Uncontrollability and Danger, and e) Need to Control Thoughts

  3. Cognitive Attentional Syndrome Scale (CAS-1) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The CAS-1 is a 10-item self-report measure assessing: a) the degree to which individuals have been dwelling on or worrying and/or focusing attention on threats, b) strategies used to cope with negative feelings and thoughts, and c) the degree to which individuals hold positive and negative metacognitive beliefs about worry

  4. Impact of Events Scale - Revised (IES-R) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events

  5. Health Related Quality of Life (EQ-5D) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The ED-5D is a standardised questionnaire for use as a measure of health status. It assesses: a) mobility, b) self-care, c) usual activities, d) pain/discomfort, and e) anxiety/depression, and the overall health status

  6. Economic Patient Questionnaire (EPQ) [ Time Frame: Baseline, 4 months follow up, 12 months follow up ]
    The EPQ assesses the services the patients have used as part of their health and social care

  7. Credibility questionnaire (regarding the Home-MCT intervention) [ Time Frame: From the completion of the introduction of the Home-MCT manual up to 2 weeks ]
    This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress

  8. Adherence questionnaire (regarding the Home-MCT intervention) [ Time Frame: From the completion of the manual up to 4 months ]
    This is a 6-item self-report questionnaire assessing adherence to Home-MCT

  9. Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT) [ Time Frame: Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention ]
    Interviews are aimed to explore patient's experiences of going through the Home-MCT intervention



Information from the National Library of Medicine

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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:

  1. Patients who are referred to the CR pathway who meet Department of Health (DoH) and/or British Association for Cardiovascular Prevention and Rehabilitation (BACPR) CR eligibility criteria:

    • Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
    • Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
    • Stable heart failure
    • Stable angina is chest pain or discomfort that most often occurs with activity or stress
    • Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
    • Heart valve repair/replacement
    • Heart transplantation and ventricular assist devices
    • Adult congenital heart disease identified in adulthood
    • Other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain)
  2. A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
  3. Minimum of 18 years old
  4. Competent level of English language skills

Exclusion Criteria:

  1. Cognitive impairment which precludes informed consent or ability to participate
  2. Acute suicidality
  3. Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
  4. Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
  5. Concurrent psychological intervention for emotional distress that is not part of usual care
  6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
  7. 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): NCT03129282


Contacts
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Contact: Adrian Wells, PhD 00 44 161 276 5399 adrian.wells@manchester.ac.uk
Contact: Cintia Faija, PhD 00 44 161 276 3312 cintia.faija@gmmh.nhs.uk

Locations
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United Kingdom
Bolton NHS Foundation Trust Recruiting
Bolton, United Kingdom
Contact: Joanne Varker         
Aintree Liverpool NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Contact: Davies Gershan         
Sponsors and Collaborators
University of Manchester
Greater Manchester Mental Health NHS Foundation Trust
University of Liverpool
Investigators
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Principal Investigator: Adrian Wells, PhD University of Manchester
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adrian Wells, Professor, University of Manchester
ClinicalTrials.gov Identifier: NCT03129282    
Other Study ID Numbers: 186990 (RP-PG-1211-20011)
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms