Clinical trial NCT04663243: Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression
Official title: Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression to Improve Maternal Health, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Depression
Keywords: Antenatal depression
psychosocial factors
Thinking Healthy Program
Lead sponsor: University of the Punjab
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi experimental study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Assessment of antenatal depression
timeFrame: Five months
measure: Assessment of postpartum depression after 6 sessions of Thinking Healthy Program
timeFrame: After delivery to 6 weeks (puerperium period)
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayed Hospital
state: Punjab
Study officials:
affiliation: Human Development Research Foundation, Pakistan
name: Abid Malik, PhD
role: STUDY_CHAIR
References: