Effectiveness of Thinking Healthy Program for Prevention of Antenatal Depression (PAD)

• ClinicalTrials.gov Identifier: NCT04663243
• Recruitment Status: Completed
• First Posted: December 10, 2020
• Last Update Posted: September 23, 2021
• Sponsor: University of the Punjab
• Information provided by (Responsible Party): Quratulain Ahsan, University of the Punjab

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
Post Partum Depression	Behavioral: Thinking healthy Program sessions designed for antenatal period	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Quasi 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: July 3, 2020
• Actual Primary Completion Date: January 29, 2021
• Actual Study Completion Date: April 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 Name: Psychoeducation

Outcome Measures

Primary Outcome Measures :

1. Assessment of antenatal depression [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 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.
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Pakistan

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)

Documents provided by Quratulain Ahsan, University of the Punjab:

Study Protocol  [PDF] June 23, 2020

Informed Consent Form  [PDF] March 13, 2020

More Information

• Responsible Party: Quratulain Ahsan, Principal Investigator, University of the Punjab
• ClinicalTrials.gov Identifier: NCT04663243
• Other Study ID Numbers: THP in clinical settings
• First Posted: December 10, 2020
• Last Update Posted: September 23, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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. 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)].
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 30-3-2021
• Access Criteria: Data will be available in the form of publication, after the acceptance of paper.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Quratulain Ahsan, University of the Punjab:

Antenatal depression; psychosocial factors; Thinking Healthy Program

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications