Change Your Life With Seven Sheets of Paper

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Change Your Life With Seven Sheets of Paper: A Pilot Randomized Controlled Trial for Postnatal Depression: A Pilot Randomized Controlled Trial for Postnatal Depression

Conditions
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Postnatal Depression

Intervention / Treatment
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* Other: CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT seven sheets<br>8 sessions of CBT based intervention called change your life with seven sheets of paper | Other: CBT<br>* 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; Five Areas vicious circle Bad thought spotter Amazing Bad thought Busting Programme (ABTPB) Easy 4 Step plan Things you do that mess you up/Confidence sheet Happy List/ Things you do that boost how you feel sheet Planner and Review sheets<br>|
| No Intervention: Treatment As Usual<br>Treatment As Usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale (EPDS) | EPDS will be used to assess postnatal depression | Change in scores from baseline to 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient health Questionnaire-9 | PHQ-9 will be used to assess severity of depression | Change in scores from baseline to 3rd month | 
| World Health Organization Quality of Life |  | Change in scoares from baseline to 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postnatal depression, Cognitive behaviour Therapy, Traditional Birth Attendants, low income country