Change Your Life With Seven Sheets of Paper

Phase 2

Completed

• Conditions: Postnatal Depression
• Interventions: Other: CBT

• Registration Number: NCT02532504
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief Summary

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

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 Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-15
• Study First Submitted QC: 2015-08-22
• Study First Posted: 2015-08-25
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT seven sheets	CBT	8 sessions of CBT based intervention called "change your life with seven sheets of paper"

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS)	Change in scores from baseline to 3rd month	EPDS will be used to assess postnatal depression

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orangi Town; 🇵🇰 Karachi, Pakistan