Myocardial InfarctionNCT04347525
The Effect of Culturally Adapted CBT-based Guided Self Help in Depressed Patients With Myocardial Infarction
A study testing CaCBT based guided self help using Khushi aur Khatoon Manual in people with Myocardial Infarction and Depression, run by Peshawar Medical College at 1 site in Pakistan.
Trial summary
This is a randomized controlled assessor-blind clinical trial comparing CaCBT based guided self-help (using a manual titled Khushi Aur Khatoon) against treatment as usual (TAU) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myocardial Infarction, Depression
- What is being tested?
- CaCBT based guided self help using Khushi aur Khatoon Manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2019to 25 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Myocardial Infarction
- Score 8 or more on HADS
- Fulfilling criteria of Major Depressive Disorder using DSM-V
Who cannot join
- Participants with use of alcohol or drugs
- Significant cognitive impairment (intellectual disability or dementia)
- Active psychosis
- Participants who have received CBT during the previous 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Culturally Adapted Cognitive Behaviour Therapy (CaCBT)-Based Guided Self Help in Depressed Patients With Myocardial Infarction. A Randomised Controlled Trial
This is a randomized controlled assessor-blind clinical trial comparing CaCBT based guided self-help (using a manual titled Khushi Aur Khatoon) against treatment as usual (TAU)
Read the detailed description
Among patients with heart disease, depression and anxiety disorders are extremely common. After a myocardial infarction (MI), depression tends to persist over the next year. Similarly, among individuals who have significantly elevated anxiety following an episode of acute coronary syndrome, only 50% have a resolution of their anxiety in the year after the event, which suggests that anxiety can remain a chronic problem for many patients. Depression confers a 2-fold increased risk of mortality and adverse cardiac events after MI or heart failure and has been linked to poor outcomes after cardiac surgery.
Cognitive behavioural therapy (CaCBT) is the best-studied form of psychotherapy in patients who have had a myocardial infarction, in reducing depressive symptoms. However, there is a dearth of literature on the use of psycho-social interventions in those with medical problems in low and middle-income countries. This study is planned to explore the effect of culturally adapted Cognitive Behavioural Therapy (CaCBT) based Guided self-help (using the book, Khushi Aur Khatoon) compared with treatment as usual in improving depression in MI patients. Participants visiting the Punjab Institute of Cardiology - Lahore, who meet the entry criteria will be randomly allocated to one of the groups, i.e., CaCBT (Intervention group) or TAU (Control Group) in a 1:1 ratio. after taking written informed consent.
With a 5% significance level and 90% power, it was calculated that 48 subjects per group were required for the trial, with a total number of 96. To accommodate up to 30% of the dropout, the participants plan to recruit 140 participants in the study.
Participants were assessed at baseline and 9-12 weeks (end of therapy) from baseline. The primary outcome measure was the Hospital Anxiety and Depression Scale (HADS). The secondary outcome measures include HADS Anxiety and Depression Subscales; Bradford Somatic Inventory (BSI) and World Health Organization Disability Assessment Schedule (WHO DAS 2.0). The participants also measured satisfaction with the treatment at the end of therapy using a visual analog scale.
The participants followed the CONSORT guidelines for reporting randomized controlled trials. The analyses were carried out on an intention-to-treat basis using SPSS version 25. Comparisons for intention-to-treat analysis participants were included in the groups to which they are randomized regardless of how long or even whether they received the treatment allocated to them or not. Missing values were imputed using the last observation carried forward (LOCF) method. Both Chi-Square and t-tests were used for baseline comparisons. End-of-therapy scores on various outcome measures between the Intervention and the Control groups were compared using an Analysis of Covariance (ANCOVA) to adjust for baseline scores.
- Conditions
- Myocardial Infarction, Depression
- Being tested
- CaCBT based guided self help using Khushi aur Khatoon Manual
- Keywords
- Cognitive Behaviour Therapy, Depression, Myocardial Infarction, Guided Self Help
- Medical subject headings
- Myocardial Infarction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaCBT based guided self help using Khushi aur Khatoon ManualOther
CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will receive CaCBT based guided self-help using the manual (Khushi Aur Khatoon) as an intervention in addition to treatment as usual Receives: Other: CaCBT based guided self help using Khushi aur Khatoon Manual |
| Control | No intervention | This group will receive treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale-Depression Subscale (HAD-D)
Change in the score of the Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy. The total score is the sum of the 7 items, ranging from 0-21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of depression.
Measured: 9-12 weeks (end of therapy)
Secondary outcomes (3)
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Change in the score of the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A) from baseline to end of therapy. The total score is the sum of the 7 items, ranging from 0-21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety.
Measured: 9-12 weeks (end of therapy)
Bradford Somatic Inventory (BSI)
Change in the score of Bradford Somatic Inventory (BSI) from baseline to end of therapy. Respondents rank each feeling item on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past 7 days. Scores can be summed for each dimension, or calculated into each global index.
Measured: 9-12 weeks (end of therapy)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Change in the score of World Health Organisation Disability Assessment Schedule (WHODAS 2.0) from baseline to end of therapy. The total score for WHODAS ranges from 0-100, where a high score indicates major living limitations.
Measured: 9-12 weeks (end of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start22 Oct 2019
- Primary completion15 Mar 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peshawar Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Association of Cognitive Therapists
- Responsible party
- Principal investigator, Muhammad Irfan, Peshawar Medical College
- Investigators
- Farooq Naeem, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347525
- Sponsor's protocol ID
- CBT Post-MI LHR
- Status last verified
- Nov 2022
- First submitted
- 13 Apr 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Culturally Adapted Cognitive Behaviour Therapy (CaCBT)-Based Guided Self Help in Depressed Patients With Myocardial Infarction. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04347525
- Acronym / sponsor ID
- CBT Post-MI LHR
- Conditions
- Myocardial Infarction, Depression
- Keywords
- Cognitive Behaviour Therapy, Depression, Myocardial Infarction, Guided Self Help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Peshawar Medical CollegeUniversity, hospital or other
- Collaborators
- Pakistan Association of Cognitive Therapists
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 15 Apr 2020 (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.
This is a randomized controlled assessor-blind clinical trial comparing CaCBT based guided self-help (using a manual titled Khushi Aur Khatoon) against treatment as usual (TAU)
Detailed description
Among patients with heart disease, depression and anxiety disorders are extremely common. After a myocardial infarction (MI), depression tends to persist over the next year. Similarly, among individuals who have significantly elevated anxiety following an episode of acute coronary syndrome, only 50% have a resolution of their anxiety in the year after the event, which suggests that anxiety can remain a chronic problem for many patients. Depression confers a 2-fold increased risk of mortality and adverse cardiac events after MI or heart failure and has been linked to poor outcomes after cardiac surgery.
Cognitive behavioural therapy (CaCBT) is the best-studied form of psychotherapy in patients who have had a myocardial infarction, in reducing depressive symptoms. However, there is a dearth of literature on the use of psycho-social interventions in those with medical problems in low and middle-income countries. This study is planned to explore the effect of culturally adapted Cognitive Behavioural Therapy (CaCBT) based Guided self-help (using the book, Khushi Aur Khatoon) compared with treatment as usual in improving depression in MI patients. Participants visiting the Punjab Institute of Cardiology - Lahore, who meet the entry criteria will be randomly allocated to one of the groups, i.e., CaCBT (Intervention group) or TAU (Control Group) in a 1:1 ratio. after taking written informed consent.
With a 5% significance level and 90% power, it was calculated that 48 subjects per group were required for the trial, with a total number of 96. To accommodate up to 30% of the dropout, the participants plan to recruit 140 participants in the study.
Participants were assessed at baseline and 9-12 weeks (end of therapy) from baseline. The primary outcome measure was the Hospital Anxiety and Depression Scale (HADS). The secondary outcome measures include HADS Anxiety and Depression Subscales; Bradford Somatic Inventory (BSI) and World Health Organization Disability Assessment Schedule (WHO DAS 2.0). The participants also measured satisfaction with the treatment at the end of therapy using a visual analog scale.
The participants followed the CONSORT guidelines for reporting randomized controlled trials. The analyses were carried out on an intention-to-treat basis using SPSS version 25. Comparisons for intention-to-treat analysis participants were included in the groups to which they are randomized regardless of how long or even whether they received the treatment allocated to them or not. Missing values were imputed using the last observation carried forward (LOCF) method. Both Chi-Square and t-tests were used for baseline comparisons. End-of-therapy scores on various outcome measures between the Intervention and the Control groups were compared using an Analysis of Covariance (ANCOVA) to adjust for baseline scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: CaCBT based guided self help using Khushi aur Khatoon ManualThis group will receive CaCBT based guided self-help using the manual (Khushi Aur Khatoon) as an intervention in addition to treatment as usual |
| Control | No intervention | –This group will receive treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Myocardial Infarction
- Score 8 or more on HADS
- Fulfilling criteria of Major Depressive Disorder using DSM-V
Key exclusion criteria (4 listed)
- Participants with use of alcohol or drugs
- Significant cognitive impairment (intellectual disability or dementia)
- Active psychosis
- Participants who have received CBT during the previous 12 months
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 |
|---|---|---|
| CaCBT based guided self help using Khushi aur Khatoon ManualCaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm | Other | Intervention |
Primary outcome
Hospital Anxiety and Depression Scale-Depression Subscale (HAD-D)
Time frame: 9-12 weeks (end of therapy)
Change in the score of the Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy. The total score is the sum of the 7 items, ranging from 0-21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of depression.
3 secondary outcomes
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: 9-12 weeks (end of therapy)
Bradford Somatic Inventory (BSI)
Time frame: 9-12 weeks (end of therapy)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Time frame: 9-12 weeks (end of therapy)
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 8 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
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Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Farooq Naeem, PhD study chair
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaCBT based guided self help using Khushi aur Khatoon Manual in people with Myocardial Infarction and Depression, run by Peshawar Medical College at 1 site in Pakistan.
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 3 inclusion and 4 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Hospital Anxiety and Depression Scale-Depression Subscale (HAD-D) (time frame: 9-12 weeks (end of therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.