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Completed

NCT Number: NCT02532504

Change Your Life With Seven Sheets of Paper

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.

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Key information

Conditions

Postnatal Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Orangi Town

Karachi, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Other

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

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Change in scores from baseline to 3rd month

    EPDS will be used to assess postnatal depression

Secondary outcomes

  1. Patient health Questionnaire-9

    Time frame: Change in scores from baseline to 3rd month

    PHQ-9 will be used to assess severity of depression

  2. World Health Organization Quality of Life

    Time frame: Change in scoares from baseline to 3rd month

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study 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

Acronym: CREATOR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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