Culturally Adapted CBT Based Guided Self-Help in Patients With Postnatal Depression
Condition: Postnatal Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
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: 
      The prevalence of postnatal depression(PND) in Asian countries ranges from 3.5% to 63.3%
      where Malaysia and Pakistan have the lowest and highest, respectively. Risk factors for
      postnatal depression have been clustered into biological/ physical (e.g., Vitamin B
      Deficiency), psychological (e.g., antenatal depression), obstetric/pediatric (e.g., unwanted
      pregnancy), socio-demographic (e.g., poverty), and cultural factors (e.g., preference of
      infants' gender).

      Cognitive behaviour therapy (CBT) is the best-studied form of psychotherapy in patients who
      have had Postnatal Depression, in reducing depressive symptoms. This study is planned to
      explore the effect of culturally adapted Cognitive Behaviour Therapy (CaCBT) based Guided
      self-help (using the book, Khushi Aur Khatoon) compared with treatment as usual in improving
      depression in PND patients. Participants visiting a tertiary care hospital in Karachi, 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.

      The sample size calculation is based on the assumption of using an Analysis of Covariance
      (ANCOVA) to analyze the outcome while controlling for baseline and is based on formulas given
      by Van Breukelen GJP and Borm GF et al. The investigators assume a correlation between
      baseline EPDS and endpoint EPDS of 0.5, 90% power, and a significance level of 0.05 with the
      two-sided test. A sample of 48 subjects per group is sufficient to achieve the expected power
      to detect an effect size equivalent to Cohen's d=0.3, which is a small to medium effect size.
      Considering means and standard deviations, this effect is equivalent to a difference of 0.8
      points at the post, between the groups, in average EPDS score. To accommodate for up to 30%
      of dropouts, the investigators 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 Edinburgh Postnatal Depression Scale (EPDS). The secondary
      outcome measures include Bradford Somatic Inventory (BSI) and World Health Organization
      Disability Assessment Schedule (WHO DAS 2.0). The investigators also measured satisfaction
      with the treatment at the end of therapy using a visual analog scale from the intervention
      group.

      The investigators 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; Postnatal Depression; Guided Self Help