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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Manchester Mental Health & Social Care Trust | OTHER_GOV |
| University of Liverpool | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| CR alone (control) | Active Comparator | Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) | Baseline pre treatment, four-month post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Wells, Ph.D | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macclesfield District General Hospital | Macclesfield | Cheshire | SK10 3BL | United Kingdom | ||
| Central Manchester University Hospitals NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34148379 | Result | 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. | |
| 35722590 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Cardiac Rehabilitation (treatment as usual) | Behavioral | Stress management, relaxation training, exercise and dietary advice. |
|
| 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 |
| Hospital Anxiety and Depression Scale | 12 month follow-up |
| Manchester |
| Lancashire |
| M13 9WL |
| United Kingdom |
| University Hospital of South Manchester NHS Foundation Trust | Manchester | Lancashire | M23 9LT | United Kingdom |
| Pennine Acute Hospitals NHS Trust | Manchester | M8 5RB | United Kingdom |
| Stepping Hill Hospital | Manchester | SK2 7JE | United Kingdom |
| Derived |
| 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. |
| 31433708 | Derived | 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. |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |