Clinical trial NCT04347499: Culturally Adapted CBT Based Guided Self-Help in Patients With Postnatal Depression
Official title: The Effect Of Culturally Adapted Cognitive Behaviour Therapy (CaCBT) Based Guided Self-Help in Patients With Postnatal Depression: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: Cognitive Behaviour Therapy
Postnatal Depression
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: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 9-12 weeks (end of therapy)
Secondary outcomes:
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: Karachi
country: Pakistan
facility: Zainab Panjwani Hospital
Study officials:
affiliation: University of Toronto
name: Farooq Naeem, PhD
role: STUDY_CHAIR
References: