Change Your Life With Seven Sheets of Paper (CREATOR)

January 13, 2017 updated by: Pakistan Institute of Living and Learning

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Orangi Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT seven sheets
8 sessions of CBT based intervention called "change your life with seven sheets of paper"
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;

  1. Five Areas vicious circle
  2. Bad thought spotter
  3. Amazing Bad thought Busting Programme (ABTPB)
  4. Easy 4 Step plan
  5. Things you do that mess you up/Confidence sheet
  6. Happy List/ Things you do that boost how you feel sheet
  7. Planner and Review sheets
No Intervention: Treatment As Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Change in scores from baseline to 3rd month
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
Time Frame: Change in scores from baseline to 3rd month
PHQ-9 will be used to assess severity of depression
Change in scores from baseline to 3rd month
World Health Organization Quality of Life
Time Frame: Change in scoares from baseline to 3rd month
Change in scoares from baseline to 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Investigators

  • Principal Investigator: Batool Fatima, Pakistan Institute of Living and Learning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 15, 2015

First Submitted That Met QC Criteria

August 22, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREATOR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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