Change Your Life With Seven Sheets of Paper

NCT ID: NCT02532504

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Postnatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

CBT seven sheets

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

Group Type: EXPERIMENTAL

CBT

Intervention Type: 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

Treatment As Usual

Treatment As Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Batool Fatima

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Locations

Orangi Town

Karachi, , Pakistan

Countries

Pakistan

Other Identifiers

CREATOR001

Identifier Type: -

Identifier Source: org_study_id