The Effect of Culturally Adapted CBT-based Guided Self Help in Depressed Patients With Myocardial Infarction
Condition: Myocardial Infarction; Depression
MeSH terms: Myocardial Infarction; Infarction; Depression
Study type: Interventional

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.
    

Intervention name(s): CaCBT based guided self help using Khushi aur Khatoon Manual
Intervention type(s): Other
Intervention description(s): CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behaviour Therapy; Depression; Myocardial Infarction; Guided Self Help