Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression

NCT04663243 | Completed DMC

• 1 other identifier: THP in clinical settings
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Depression

Keywords

Antenatal depression; psychosocial factors; Thinking Healthy Program

Outcome Measures

Primary Outcomes (2)

• 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

  Five months

• 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

  After delivery to 6 weeks (puerperium period)

Study Arms (1)

Quasi experimental study

EXPERIMENTAL

Before intervention and after intervention comparison

Behavioral: Thinking healthy Program sessions designed for antenatal period

Interventions

Thinking healthy Program sessions designed for antenatal period BEHAVIORAL

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.

Also known as: Psychoeducation

Quasi experimental study

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Punjab: lead

Study Sites (1)

Sheikh Zayed Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Ahsan Q, Saleem J, Ishaq M, Zakar R, Abbas S, Shahzad R, Khan SM, Fischer F. Determinant factors and coping strategies for depression among pregnant women: an intervention-based qualitative study in Lahore, Pakistan. BMC Psychiatry. 2024 Nov 19;24(1):829. doi: 10.1186/s12888-024-06280-3.

  PMID: 39563299 DERIVED

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

• Abid Malik, PhD

  Human Development Research Foundation, Pakistan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi experimental study

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: December 10, 2020
• Study Start: July 3, 2020
• Primary Completion: January 29, 2021
• Study Completion: April 29, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 30-3-2021
• Access Criteria: Data will be available in the form of publication, after the acceptance of paper.

Locations

PA (1)