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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02532504
Date of registration:	15/08/2015
Prospective Registration:	No
Primary sponsor:	Pakistan Institute of Learning and Living
Public title:	Change Your Life With Seven Sheets of Paper CREATOR
Scientific 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
Date of first enrolment:	August 2015
Target sample size:	36
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02532504
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Masking: Single (Outcomes Assessor).
Phase:	Phase 2

Countries of recruitment
Pakistan

Contacts

Name:	Batool Fatima
Address:
Telephone:
Email:
Affiliation:	Pakistan Institute of Learning and Living

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postnatal Depression

Intervention(s)

Other: CBT

Primary Outcome(s)

Edinburgh Postnatal Depression Scale (EPDS) [Time Frame: Change in scores from baseline to 3rd month]

Secondary Outcome(s)

World Health Organization Quality of Life [Time Frame: Change in scoares from baseline to 3rd month]

Patient health Questionnaire-9 [Time Frame: Change in scores from baseline to 3rd month]

Secondary ID(s)

CREATOR001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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