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Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression (PAD)

Primary Purpose

Post Partum Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Thinking healthy Program sessions designed for antenatal period
Sponsored by
University of the Punjab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Depression focused on measuring Antenatal depression, psychosocial factors, Thinking Healthy Program

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with 24-26 weeks pregnancy.
  • Women assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] tool validated in Pakistan for the use of non-specialist.

Exclusion Criteria:

  • Women having depression severe depression [i.e., score ≥20 on Personal Health Care Questionnaire (PHQ-9)]
  • Women will be diagnosed serious medical condition requiring inpatient or outpatient treatment,
  • Pregnancy-related illness (except for common conditions, such as anaemia)
  • Any physical or learning disability or other form of psychosis
  • Women younger than 18 and greater than 45 years will also be excluded.

Sites / Locations

  • Sheikh Zayed Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quasi experimental study

Arm Description

Before intervention and after intervention comparison

Outcomes

Primary Outcome Measures

Assessment of antenatal depression
Screening of patients with antenatal depression using PHQ-9 tool for calculation of percentage(%) of depressive women in pregnancy before 6 sessions of Thinking Healthy Program
Assessment of postpartum depression after 6 sessions of Thinking Healthy Program
Screening of patients with post depression using PHQ-9 tool for calculation of percentage(%) of depressive women in postpartum period

Secondary Outcome Measures

Full Information

First Posted
October 30, 2020
Last Updated
September 22, 2021
Sponsor
University of the Punjab
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1. Study Identification

Unique Protocol Identification Number
NCT04663243
Brief Title
Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression
Acronym
PAD
Official Title
Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Punjab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Investigator will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist.
Detailed Description
The present study aims to evaluate the effectiveness of evidence informed, depression focused early prenatal prevention intervention in pregnant women at six weeks' postpartum. Investigator hypothesize that women with subclinical to clinical levels of prenatal depression to the intervention will result in fewer cases of depression (mild to moderate) at six weeks' postpartum. The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. We will also examine the potential mediators of depression and the effect of intervention on depression and its related factors i.e. marital relationship, social support, empowerment and history of intimate partner violence. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] validated in Pakistan for the use of non-specialist. An intervention thinking Healthy Program (THP) will be done in which Investigator will enroll up to twenty (20) pregnant women. Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP), an evidence-based psychosocial intervention for mothers experiencing perinatal depression, including empathetic listening, thought challenging, behavior activation, family involvement, and problem management. Additionally, stress management skills such as breathing exercises are incorporated. Culturally relevant customized illustrations are used for guided discovery, behavior activation, stress management, and to convey key health messages. The intervention is a series of one-on-one sessions, complemented by take home exercises. Before and after intervention comparison will be made to find out the efficacy of intervention. The data will be collected at one site: Sheikh Zayed Hospital, a public tertiary care facility in Lahore, Pakistan. It will take six months for data collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
Keywords
Antenatal depression, psychosocial factors, Thinking Healthy Program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi experimental study
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quasi experimental study
Arm Type
Experimental
Arm Description
Before intervention and after intervention comparison
Intervention Type
Behavioral
Intervention Name(s)
Thinking healthy Program sessions designed for antenatal period
Other Intervention Name(s)
Psychoeducation
Intervention Description
Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP). Four core sessions and two booster sessions will be applied, designed for antenatal period to prevent antenatal and post partum depression.
Primary Outcome Measure Information:
Title
Assessment of antenatal depression
Description
Screening of patients with antenatal depression using PHQ-9 tool for calculation of percentage(%) of depressive women in pregnancy before 6 sessions of Thinking Healthy Program
Time Frame
Five months
Title
Assessment of postpartum depression after 6 sessions of Thinking Healthy Program
Description
Screening of patients with post depression using PHQ-9 tool for calculation of percentage(%) of depressive women in postpartum period
Time Frame
After delivery to 6 weeks (puerperium period)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] tool validated in Pakistan for the use of non-specialist.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with 24-26 weeks pregnancy. Women assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)] tool validated in Pakistan for the use of non-specialist. Exclusion Criteria: Women having depression severe depression [i.e., score ≥20 on Personal Health Care Questionnaire (PHQ-9)] Women will be diagnosed serious medical condition requiring inpatient or outpatient treatment, Pregnancy-related illness (except for common conditions, such as anaemia) Any physical or learning disability or other form of psychosis Women younger than 18 and greater than 45 years will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abid Malik, PhD
Organizational Affiliation
Human Development Research Foundation, Pakistan
Official's Role
Study Chair
Facility Information:
Facility Name
Sheikh Zayed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The primary objective of the trial is to evaluate the effect of an evidence-informed, depression focused early prenatal prevention intervention at six weeks' postpartum. Secondary objective is to explore demographical and psychosocial factors responsible for development of prenatal and postpartum depression. Pregnant women coming for their antenatal visits to the Sheikh Zayed Hospital (SZH), a public facility in Lahore, Pakistan, will be screened for eligibility. Eligible women will be 24-26 weeks pregnancy who will be assessed as having mild to moderate levels of depression [i.e., score ≥10 on Personal Health Care Questionnaire (PHQ-9)].
IPD Sharing Time Frame
30-3-2021
IPD Sharing Access Criteria
Data will be available in the form of publication, after the acceptance of paper.

Learn more about this trial

Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression

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