The Effect of Culturally Adapted CBT-based Guided Self Help in Depressed Patients With Myocardial Infarction
Study Details
Study Description
Brief 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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 an acute coronary syndrome, only 50% have a resolution of their anxiety in the year after the event, which suggests that for many patients anxiety can remain a chronic problem. 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 (CBT) 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 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 will be required for the trial, with a total number of 96. To accommodate for upto 30% of drop out, we plan to recruit 140 participants in the study.
Participants will be assessed at baseline and 8 weeks (end of therapy) from baseline. Primary outcome measure will be 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). We will also measure satisfaction with the treatment at the end of therapy using a visual analogue scale.
We will follow the CONSORT guidelines for reporting of randomized controlled trials. The analyses will be carried out on an intention-to-treat basis using SPSS version 25. Comparisons for an intention to treat analysis participants will be 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 will be imputed using the last observation carried forward (LOCF) method. Both Chi-Square and t-test will be used for baseline comparisons. End of therapy scores on various outcome measures between the Intervention and the Control groups will be compared using an Analysis of Covariance (ANCOVA) to adjust for baseline scores.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention This group will receive CaCBT based guided self-help using the manual (Khushi Aur Khatoon) as an intervention in addition to treatment as usual |
Other: CaCBT based guided self help using Khushi aur Khatoon Manual
CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
|
| No Intervention: Control This group will receive treatment as usual |
Outcome Measures
Primary Outcome Measures
- Hospital Anxiety and Depression Scale (HADS) [8 weeks (end of therapy)]
Change in the score of Hospital Anxiety and Depression Scale (HADS) from baseline to end of therapy
Secondary Outcome Measures
- Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [8 weeks (end of therapy)]
Change in the score of Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) from baseline to end of therapy
- Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) [8 weeks (end of therapy)]
Change in the score of Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) from baseline to end of therapy
- Bradford Somatic Inventory (BSI) [8 weeks (end of therapy)]
Change in the score of Bradford Somatic Inventory (BSI) from baseline to end of therapy
- World Health Organisation Disability Assessment Schedule (WHODAS 2.0) [8 weeks (end of therapy)]
Change in the score of World Health Organisation Disability Assessment Schedule (WHODAS 2.0) from baseline to end of therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Myocardial Infarction
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Score 8 or more on HADS
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Fulfilling criteria of Major Depressive Disorder using DSM-V
Exclusion Criteria:
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Participants with use of alcohol or drugs
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Significant cognitive impairment (intellectual disability or dementia)
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Active psychosis
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Participants who have received CBT during the previous 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Punjab Institute of Cardiology | Lahore | Punjab | Pakistan |
Sponsors and Collaborators
- Peshawar Medical College
- Pakistan Association of Cognitive Therapists
Investigators
- Study Chair: Farooq Naeem, PhD, University of Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBT Post-MI LHR