Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression

NCT ID: NCT04663243

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-03
• Study Completion Date: 2021-04-29

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.

Conditions

Post Partum Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Quasi experimental study

Before intervention and after intervention comparison

Group Type: EXPERIMENTAL

Thinking healthy Program sessions designed for antenatal period

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychoeducation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of the Punjab

OTHER

Sponsor Role: lead

Responsible Party

Quratulain Ahsan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abid Malik, PhD

Role: STUDY_CHAIR

Human Development Research Foundation, Pakistan

Locations

Sheikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 39563299 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

THP in clinical settings

Identifier Type: -

Identifier Source: org_study_id