Clinical trial NCT04347525: The Effect of Culturally Adapted CBT-based Guided Self Help in Depressed Patients With Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Depression
Keywords: Cognitive Behaviour Therapy
Depression
Myocardial Infarction
Guided Self Help
Lead sponsor: Peshawar Medical College
Sponsor class: OTHER
Collaborators: name: Pakistan Association of Cognitive Therapists
First posted: 2020-04-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Myocardial Infarction
* Score 8 or more on HADS
* Fulfilling criteria of Major Depressive Disorder using DSM-V

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale-Depression Subscale (HAD-D)
timeFrame: 9-12 weeks (end of therapy)
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
timeFrame: 9-12 weeks (end of therapy)
measure: Bradford Somatic Inventory (BSI)
timeFrame: 9-12 weeks (end of therapy)
measure: World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
timeFrame: 9-12 weeks (end of therapy)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab Institute of Cardiology
state: Punjab
Study officials:
affiliation: University of Toronto
name: Farooq Naeem, PhD
role: STUDY_CHAIR
References: