Culturally Adapted CBT Based Guided Self-Help in Patients With Postnatal Depression

The Effect Of Culturally Adapted Cognitive Behaviour Therapy (CaCBT) Based Guided Self-Help in Patients With Postnatal Depression: 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)

Study Overview

• Status: Completed
• Conditions: Postnatal Depression
• Intervention / Treatment: Other: CaCBT based guided self help using Khushi aur Khatoon Manual

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Zainab Panjwani Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Score of 10 or more on EPDS
• Fulfilling criteria of Major Depressive Disorder using DSM-V with a specifier of Peripartum Onset.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This group will receive CaCBT based guided selfhelp 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS)	Change in the score of Edinburgh Postnatal Depression (EPDS) from baseline to end of therapy Minimum Score = 0 Maximum Score = 30 Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Higher scores means a worse outcome.	9-12 weeks (end of therapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bradford Somatic Inventory (BSI)	Change in the score of Bradford Somatic Inventory (BSI) from baseline to end of therapy Minimum Score = 0 Maximum Score = 92 Higher scores mean a worse outcome.	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 Minimum Score = 0 Maximum Score = 48 Higher scores mean a worse outcome.	9-12 weeks (end of therapy)

Collaborators and Investigators

• Sponsor: Peshawar Medical College
• Collaborators: Pakistan Association of Cognitive Therapists
• Investigators: Study Chair: Farooq Naeem, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive Behaviour Therapy; Postnatal Depression; Guided Self Help
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: CBT PND KHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No