Change Your Life With Seven Sheets of Paper

NCT02532504 | Completed Phase 2 DMC

• 1 other identifier: CREATOR001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnatal Depression

Keywords

postnatal depression; Cognitive behaviour Therapy; Traditional Birth Attendants; low income country

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale (EPDS)

  EPDS will be used to assess postnatal depression

  Change in scores from baseline to 3rd month

Secondary Outcomes (2)

• Patient health Questionnaire-9

  Change in scores from baseline to 3rd month

• World Health Organization Quality of Life

  Change in scoares from baseline to 3rd month

Study Arms (2)

CBT seven sheets

EXPERIMENTAL

8 sessions of CBT based intervention called "change your life with seven sheets of paper"

Other: CBT

Treatment As Usual

NO INTERVENTION

Treatment As Usual

Interventions

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; 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

CBT seven sheets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Orangi Town

Karachi, Pakistan

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Batool Fatima

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2015-08

Locations

PA (1)