DepressionNCT03999359
A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)
A study testing Home-based Metacognitive Therapy in people with Depression and Anxiety, run by University of Manchester at 5 sites in United Kingdom.
Trial 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. 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?
- Home-based Metacognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 14 May 2019to 7 Aug 2020
- 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
- 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
Show all 13Show fewer
- 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)
- A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
- Minimum of 18 years old
- Competent level of English language skills
Who cannot join
- Cognitive impairment which precludes informed consent or ability to participate
- Acute suicidality
- Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
- Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
- Concurrent psychological intervention for emotional distress that is not part of usual care
- Antidepressant or anxiolytic medications initiated in the 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
Bolton NHS Foundation Trust
Bolton
Aintree Liverpool NHS Foundation Trust
Liverpool, L9 7AL
East Cheshire Nhs Trust
Macclesfield, SK10 3BL
Pennine acute hospitals nhs trust
Manchester, BL9 7TD
Manchester Foundation Trust
Manchester
About this study
Official title: A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway
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 self-help 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 evaluate the effectiveness and cost-effectiveness of Home-MCT.
- Conditions
- Depression, Anxiety, Cardiac Rehabilitation, Psychological Distress
- Being tested
- Home-based Metacognitive Therapy
- 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.
Home-based Metacognitive TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation |
| Intervention | Active comparator | Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT) Receives: Other: Home-based Metacognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.
Measured: Baseline, 4 months follow up
Secondary outcomes (8)
Metacognitions Questionnaire 30 (MCQ-30)
The MCQ-30 is a 30-item self-report scale that assesses metacognitive beliefs across five subscales: a) Cognitive Confidence, b) Positive Beliefs about Worry, c) Cognitive Self-Consciousness, d) Negative Beliefs about Uncontrollability and Dangerousness of worry, and e) Need to Control Thoughts .Each item is rated on a 4-point Likert scale, with 1 representing "do not agree" , and with 4 indicating "agree very much." Subscale scores range from 6-24 whilst total scores range from 30-120. Subscale scores are created by summing responses to the selected items. Higher subscale scores and total scores, indicate greater dysfunctional metacognitive beliefs.
Measured: Baseline, 4 months follow up
Cognitive Attentional Syndrome Scale (CAS-1)
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. Responses to these items are on 0 to 100 scale, with higher scores indicating greater use of maladaptive coping strategies and higher positive and negative metacognitive beliefs.
Measured: Baseline, 4 months follow up
Impact of Events Scale - Revised (IES-R)
The IES-R is a 22-item self-report measure that assesses symptoms of post-traumatic stress disorder. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores range from 0-88, with higher scores indicating higher levels of subjective distress caused by traumatic events.
Measured: Baseline, 4 months follow up
Health Related Quality of Life (EQ-5D-5L)
The ED-5D-5L is a standardised questionnaire for use as a measure of health status. The ED-5D-5L consists of 2 parts: a descriptive system and a visual analogue scale. The descriptive system consist of 5 separate dimensions which include mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients report the severity of problems they face concerning each dimension, with responses ranging from 1-5, whereby higher scores indicate more severe problems. These numbers can then be combined for each dimension to provide a 5 digit value for describing the patients' health state. The visual analogue component of the ED-5D-5L consists of the patient/participant rating their own health that day, on a scale of 0-100 with 100 indicating the best health they can imagine and 0 indicating the worst health they can imagine.
Measured: Baseline, 4 months follow up
Credibility questionnaire (regarding the Home-MCT intervention)
This is a 3-item self-report questionnaire assessing Home-MCT credibility to reduce psychological distress. Items are rated from 0 to 100, where 0 indicates less credibility of the home-MCT manual, and 100 indicates greater credibility of the home-MCT manual.
Measured: From the completion of the introduction of the Home-MCT manual up to 2 weeks
Adherence questionnaire (regarding the Home-MCT intervention)
This is a 6-item self-report questionnaire assessing adherence to Home-MCT. Items are rated on a scale from 0 (not at all easy) to 100 (extremely easy). Items assess easy of use and clarity of the manual. Greater scores indicate greater adherence to the manual.
Measured: From the completion of the manual up to 4 months
Acceptability
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 the percentage of all patients randomised to the treatment arm, minus deaths. This will be compared to the percentage of controls (minus deaths) who complete the 4-month follow up.
Measured: From the completion of the manual till 4 months
Economic Patient Questionnaire (EPQ)
The EPQ assesses the services the patients have used as part of their health and social care. Patients indicate the type and frequency of visits to in-patient, out-patient, and/or community services.
Measured: Baseline, 4 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start14 May 2019
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Why it stopped: Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999359
- Sponsor's protocol ID
- 186990 RP-PG-1211-20011
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial. PLoS Med. 2023 Jan 31;20(1):e1004161. doi: 10.1371/journal.pmed.1004161. eCollection 2023 Jan.
PubMed 36719886
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
- A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway
- ClinicalTrials.gov ID
- NCT03999359
- Acronym / sponsor ID
- 186990 RP-PG-1211-20011
- Conditions
- Depression, Anxiety, Cardiac Rehabilitation, Psychological Distress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Greater Manchester Mental Health NHS Foundation Trust, University of Liverpool
- Study start
- 14 May 2019 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- 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.
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 self-help 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 evaluate the effectiveness and cost-effectiveness of Home-MCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation |
| Intervention | Active comparator | Other: Home-based Metacognitive TherapyParticipants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
- Minimum of 18 years old
- Competent level of English language skills
Key exclusion criteria (8 listed)
- Cognitive impairment which precludes informed consent or ability to participate
- Acute suicidality
- Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
- Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
- Concurrent psychological intervention for emotional distress that is not part of usual care
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 |
|---|---|---|
| Home-based Metacognitive TherapyHome-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. | Other | Intervention |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 4 months follow up
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.
8 secondary outcomes
Metacognitions Questionnaire 30 (MCQ-30)
Time frame: Baseline, 4 months follow up
Cognitive Attentional Syndrome Scale (CAS-1)
Time frame: Baseline, 4 months follow up
Impact of Events Scale - Revised (IES-R)
Time frame: Baseline, 4 months follow up
Health Related Quality of Life (EQ-5D-5L)
Time frame: Baseline, 4 months follow up
Credibility questionnaire (regarding the Home-MCT intervention)
Time frame: From the completion of the introduction of the Home-MCT manual up to 2 weeks
Adherence questionnaire (regarding the Home-MCT intervention)
Time frame: From the completion of the manual up to 4 months
Acceptability
Time frame: From the completion of the manual till 4 months
Economic Patient Questionnaire (EPQ)
Time frame: Baseline, 4 months follow up
Results and safety
The study was stopped early (reason given: Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Results publication: PubMed 36719886Wells A, Reeves D, Heal C, Fisher P, Doherty P, Davies L, Heagerty A, Capobianco L. Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial. PLoS Med. 2023 Jan 31;20(1):e1004161. doi: 10.1371/journal.pmed.1004161. eCollection 2023 Jan.
- Web-site with details about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Metacognitive Therapy 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 13 inclusion and 8 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: stopped early, 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 was stopped early (reason given: Due to COVID-19 recruitment was terminated prematurely following approval from the trial steering committee. Overall impact was minimal, study sample was reduced by four participants.). Results are not available in the source record.
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?
Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline, 4 months follow up). 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 NCT03999359, which also lists 1 linked publication.
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.