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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02532504
Other study ID # CREATOR001
Secondary ID
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
Health authority
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

Study Design


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
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