Change Your Life With Seven Sheets of Paper

Postnatal Depression Clinical Trial

— CREATOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532504
• Other study ID #: CREATOR001
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2015
• Last updated: January 13, 2017
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Other:
• CBT
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

Locations

Country	Name	City	State
Pakistan	Orangi Town	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale (EPDS)	EPDS will be used to assess postnatal depression	Change in scores from baseline to 3rd month
Secondary	Patient health Questionnaire-9	PHQ-9 will be used to assess severity of depression	Change in scores from baseline to 3rd month
Secondary	World Health Organization Quality of Life		Change in scoares from baseline to 3rd month