Change Your Life With Seven Sheets of Paper (CREATOR)
January 13, 2017 updated by: Pakistan Institute of Living and Learning
Change Your Life With Seven Sheets of Paper: A Pilot Randomized Controlled Trial for Postnatal Depression: A Pilot Randomized Controlled Trial for Postnatal Depression
The aim of this study is to deliver CBT based intervention called "Change your life with 7 Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained traditional birth attendants (TBAs).
Participants will be recruited from low income area in Karachi Pakistan.
Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers having children between birth till 12 months.
Group intervention will be delivered through trained TBAs.
Study Overview
Detailed Description
The prevalence rate of PND in Pakistani women and its effect on the growth and development of young children and child mortality is very high.
Despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals .
Therefore the aim of this study is to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called "Changing your life with seven sheets of paper".
Participants will be recruited from low income area in Karachi.
Total 36 participants will be recruited and randomized into 2 groups; intervention and Treatment As Usual (TAU) group.
Total 8 sessions will be delivered by trained TBAs over the period of 3 months.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karachi, Pakistan
- Orangi Town
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers with a child between 0-12 months
- Women who score 14 or above on Edinburgh Postnatal Depression scale (EPDS)
- Age range between 18 to 45 years
- Women able to provide written informed consent.
Exclusion Criteria:
- Severe depression or any other major psychiatric disorder
- Severe suicidal ideation
- Currently receiving any psychiatric or psychological treatment
- Intellectual disability in mother
- Chronic medical condition
- Having children with intellectual or physical disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CBT seven sheets
8 sessions of CBT based intervention called "change your life with seven sheets of paper"
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8 sessions of CBT based intervention called "change your life with seven sheets of paper by Prof. Chris Williams. These sheets cover key skills of CBT that are;
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No Intervention: Treatment As Usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Change in scores from baseline to 3rd month
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EPDS will be used to assess postnatal depression
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Change in scores from baseline to 3rd month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient health Questionnaire-9
Time Frame: Change in scores from baseline to 3rd month
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PHQ-9 will be used to assess severity of depression
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Change in scores from baseline to 3rd month
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World Health Organization Quality of Life
Time Frame: Change in scoares from baseline to 3rd month
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Change in scoares from baseline to 3rd month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Batool Fatima, Pakistan Institute of Living and Learning
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
August 15, 2015
First Submitted That Met QC Criteria
August 22, 2015
First Posted (Estimate)
August 25, 2015
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREATOR001
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