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
1 other identifier
interventional
140
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2020
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedNovember 8, 2022
November 1, 2022
6 months
April 13, 2020
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Bradford Somatic Inventory (BSI)
9-12 weeks (end of therapy)
World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
9-12 weeks (end of therapy)
Study Arms (2)
Intervention
EXPERIMENTALThis group will receive CaCBT based guided selfhelp using the manual (Khushi Aur Khatoon) as an intervention in addition to treatment as usual
Control
NO INTERVENTIONThis group will receive treatment as usual
Interventions
CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
Eligibility Criteria
You may qualify if:
- Score of 10 or more on EPDS
- Fulfilling criteria of Major Depressive Disorder using DSM-V with a specifier of Peripartum Onset.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zainab Panjwani Hospital
Karachi, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Farooq Naeem, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. of Psychiatry & Director Research
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 15, 2020
Study Start
August 5, 2019
Primary Completion
February 2, 2020
Study Completion
November 1, 2020
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share