DepressionPATHWAYNCT02420431
Treating Depression and Anxiety in the Cardiac Rehabilitation Pathway
A study testing Metacognitive Therapy and Cardiac Rehabilitation (treatment as usual) in people with Depression and Anxiety, run by University of Manchester at 5 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Cardiac Rehabilitation
- What is being tested?
- Metacognitive Therapy and Cardiac Rehabilitation (treatment as usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jul 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Macclesfield District General Hospital
Macclesfield, Cheshire, SK10 3BL
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Lancashire, M13 9WL
University Hospital of South Manchester NHS Foundation Trust
Manchester, Lancashire, M23 9LT
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB
Stepping Hill Hospital
Manchester, SK2 7JE
About this study
Official title: Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
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.
- Conditions
- Depression, Anxiety, Cardiac Rehabilitation
- Being tested
- Metacognitive Therapy, Cardiac Rehabilitation (treatment as usual)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyBehavioural
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)Behavioural
Stress management, relaxation training, exercise and dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Metacognitive Therapy |
| CR alone (control) | Active comparator | Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education Receives: Behavioral: Cardiac Rehabilitation (treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline pre treatment, four-month post baseline
Secondary outcomes (6)
Impact of Events Scale -revised
Measured: Baseline, four-month post baseline, 12 months follow-up
Metacognitions Questionnaire 30
Measured: Baseline, four-month post baseline, 12 month follow-up
Cognitive Attentional Syndrome scale (CAS-1)
Measured: Baseline, four-month post baseline, 12 months follow-up
Health Related Quality of Life (EQ-5D)
Measured: Baseline, four-month post baseline, 12 months follow-up
Economic Patient Questionnaire
Measured: Baseline, 4 month follow-up, 12 months follow-up
Hospital Anxiety and Depression Scale
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Manchester Mental Health & Social Care Trust, University of Liverpool
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
- Investigators
- Adrian Wells, Ph.D, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420431
- Sponsor's protocol ID
- 156862 (RP-PG-1211-20011)
- Acronym
- PATHWAY
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2015
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34148379Wells 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.
PubMed 35722590McPhillips 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.
PubMed 31433708
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02420431
- Acronym / sponsor ID
- PATHWAY / 156862 (RP-PG-1211-20011)
- Conditions
- Depression, Anxiety, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Manchester Mental Health & Social Care Trust, University of Liverpool
- Study start
- Jul 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metacognitive therapy plus CR | Experimental | Behavioral: Metacognitive TherapyGroup 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 | Behavioral: Cardiac Rehabilitation (treatment as usual)Usual group-based cardiac rehabilitation (treatment as usual) involving stress management, exercise, education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Cognitive impairment which precludes informed consent/ability to participate
- Acute suicidality
- Active psychotic disorders
- Current drug/alcohol abuse
- Concurrent psychological intervention for emotional distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TherapyMetacognitive 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 | Behavioural | metacognitive therapy plus CR |
| Cardiac Rehabilitation (treatment as usual)Stress management, relaxation training, exercise and dietary advice. | Behavioural | CR alone (control) |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline pre treatment, four-month post baseline
6 secondary outcomes
Impact of Events Scale -revised
Time frame: Baseline, four-month post baseline, 12 months follow-up
Metacognitions Questionnaire 30
Time frame: Baseline, four-month post baseline, 12 month follow-up
Cognitive Attentional Syndrome scale (CAS-1)
Time frame: Baseline, four-month post baseline, 12 months follow-up
Health Related Quality of Life (EQ-5D)
Time frame: Baseline, four-month post baseline, 12 months follow-up
Economic Patient Questionnaire
Time frame: Baseline, 4 month follow-up, 12 months follow-up
Hospital Anxiety and Depression Scale
Time frame: 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Results publication: PubMed 34148379Wells 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.
- Derived from this study: PubMed 35722590Wells 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.
- Derived from this study: PubMed 31433708McPhillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Wells, Ph.D principal investigator
University of Manchester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy and Cardiac Rehabilitation (treatment as usual) in people with Depression and Anxiety, run by University of Manchester at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline pre treatment, four-month post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420431, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.