Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression

Post Partum Depression Clinical Trial

— PAD  

Official title:

Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663243
• Other study ID #: THP in clinical settings
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: September 2021
• Source: University of the Punjab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Sheikh Zayed Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of the Punjab

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)