PAD: Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression

Sponsor
University of the Punjab (Other)
Overall Status
Completed
CT.gov ID
NCT04663243
Collaborator
(none)
22
1
1
9.9
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Thinking healthy Program sessions designed for antenatal period
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Quasi experimental studyQuasi experimental study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan
Actual Study Start Date :
Jul 3, 2020
Actual Primary Completion Date :
Jan 29, 2021
Actual Study Completion Date :
Apr 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Quasi experimental study

Before intervention and after intervention comparison

Behavioral: Thinking healthy Program sessions designed for antenatal period
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.
Other Names:
  • Psychoeducation
  • Outcome Measures

    Primary Outcome Measures

    1. Assessment of antenatal depression [Five months]

      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

    2. Assessment of postpartum depression after 6 sessions of Thinking Healthy Program [After delivery to 6 weeks (puerperium period)]

      Screening of patients with post depression using PHQ-9 tool for calculation of percentage(%) of depressive women in postpartum period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheikh Zayed Hospital Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • University of the Punjab

    Investigators

    • Study Chair: Abid Malik, PhD, Human Development Research Foundation, Pakistan

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Quratulain Ahsan, Principal Investigator, University of the Punjab
    ClinicalTrials.gov Identifier:
    NCT04663243
    Other Study ID Numbers:
    • THP in clinical settings
    First Posted:
    Dec 10, 2020
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Quratulain Ahsan, Principal Investigator, University of the Punjab
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2021