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Trial record 87 of 264 for:    Postpartum Depression AND Postpartum Depression | "Depression" AND "Depression"

Change Your Life With Seven Sheets of Paper (CREATOR)

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ClinicalTrials.gov Identifier: NCT02532504
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Postnatal Depression Other: CBT Phase 2

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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
Treatment As Usual



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532504


Locations
Pakistan
Orangi Town
Karachi, Pakistan
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
Principal Investigator: Batool Fatima Pakistan Institute of Living and Learning

Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02532504     History of Changes
Other Study ID Numbers: CREATOR001
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: August 2015

Keywords provided by Pakistan Institute of Living and Learning:
postnatal depression
Cognitive behaviour Therapy
Traditional Birth Attendants
low income country

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications