Culturally Adapted CBT Based Guided Self-Help in Patients With Postnatal Depression
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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/ paediatric (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 Zainab Panjwani Memorial Hospital - 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.
With a 5% significance level and 90% power, it was calculated that 48 subjects per group will be required for the trial, with a total number of 96. To accommodate for upto 30% of drop out, we plan to recruit 140 participants in the study.
Participants will be assessed at baseline and 8 weeks (end of therapy) from baseline. Primary outcome measure will be 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). We will also measure satisfaction with the treatment at the end of therapy using a visual analogue scale from the intervention group.
We will follow the CONSORT guidelines for reporting of randomized controlled trials. The analyses will be carried out on an intention-to-treat basis using SPSS version 25. Comparisons for an intention to treat analysis participants will be 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 will be imputed using the last observation carried forward (LOCF) method. Both Chi-Square and t-test will be used for baseline comparisons. End of therapy scores on various outcome measures between the Intervention and the Control groups will be compared using an Analysis of Covariance (ANCOVA) to adjust for baseline scores.
Study Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Edinburgh Postnatal Depression Scale (EPDS) [8 weeks (end of therapy)]
Change in the score of Edinburgh Postnatal Depression (EPDS) from baseline to end of therapy
Secondary Outcome Measures
- Bradford Somatic Inventory (BSI) [8 weeks (end of therapy)]
Change in the score of Bradford Somatic Inventory (BSI) from baseline to end of therapy
- World Health Organisation Disability Assessment Schedule (WHODAS 2.0) [8 weeks (end of therapy)]
Change in the score of World Health Organisation Disability Assessment Schedule (WHODAS 2.0) from baseline to end of therapy
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zainab Panjwani Hospital | Karachi | Pakistan |
Sponsors and Collaborators
- Peshawar Medical College
- Pakistan Association of Cognitive Therapists
Investigators
- Study Chair: Farooq Naeem, PhD, University of Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBT PND KHI