Efficacy of Mother's Time in Ethiopia

Depression, Postpartum Clinical Trial

Official title:

Efficacy of a Simplified Cognitive Behavioral Therapy Approach to Support Postpartum Mental Health and Address Social and Behavioral Barriers to Postpartum Family Planning in Ethiopia: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806463
• Other study ID #: 23020
• Status: Completed
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to support postpartum women experiencing mild to moderate symptoms of stress, depression or anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs) and includes CBT exercises and discussion on topics relating to family planning, such as planning for the future, speaking to the husband, and considering potential side effects. The primary objective of this research is to test the efficacy of Mother's Time, on mild to moderate symptoms of postpartum stress, anxiety, and depression as well as associated behavioral and social barriers to postpartum family planning, specifically among women under 25 who have given birth within the last year.

Description:

Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to support postpartum women experiencing mild to moderate symptoms of stress, depression, or anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs) and includes CBT exercises and discussion on topics relating to family planning, such as planning for the future, speaking to the husband, and considering potential side effects. The primary objective of this research is to test the efficacy of Mother's Time, on mild to moderate symptoms of postpartum stress, anxiety, and depression as well as associated behavioral and social barriers to postpartum family planning, specifically among women under 25 who have given birth within the last year. This study builds on evidence from a previous study (Principal Investigator: Hendrickson, Institutional Review Board (IRB) #: 16604) demonstrating the feasibility and acceptability of using Mother's Time to address mild to moderate depressive and anxiety symptoms and associated behavioral and social barriers to family planning in Ethiopia. The study also builds on previous human-centered design work (Principal Investigator: Hendrickson, IRB #: 21414) to obtain further design input on the Mother's Time intervention. The investigators have adapted the intervention based on data and findings from the pilot study and the Human Centered Design workshop. The specific aims of this study are to: 1) Quantitatively examine the impact of participating in Mother's Time on symptoms of stress, depression, and anxiety among postpartum women ages 16-24 years of age who have given birth within the last year. 1a) Assess the immediate (post intervention) and longer term (3-month post-intervention) impact of participation in Mother's Time on symptoms of stress, depression, and anxiety. 2) Quantitatively assess the impact of participating in Mother's Time on use of a modern contraceptive method among postpartum women ages 16-24 years of age who have given birth within the last year. 2a) Assess the immediate (post intervention) and longer term (3-month post-intervention) impact of participation in Mother's Time on use of a modern contraceptive method among postpartum women. 2b) Quantitatively assess the impact of participating in Mother's Time on perceived benefits and self-efficacy to engage in healthy thinking patterns and modify behaviors related to family planning. 3) Explore feasibility and acceptability of implementing Mothers Time from the perspective of health extension workers (HEWs) and HEW supervisors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• Has given birth within the last year to an infant who is still living
• Not currently using a method of modern family planning (Women who are breastfeeding but not following the Lactation Amenorrhea Method (LAM) criteria will be considered "not using")
• Married (traditional, religious or legal)
• Aged 16-24 (participants under 18 will be considered emancipated minors as these individuals will be married)
• Scores between 5 and 14 on the PHQ-9 questionnaire and/or between 5 and 14 on the GAD-7 questionnaire
• In screener, does not indicate she has "death ideation" ("no" response on question 14) Consents to participate in study

Exclusion Criteria:

• Unmarried women
• Women under age 16 or over age 24
• Women who have lost their infants since birth
• Scores under 5 on both the PHQ-9 and GAD-7 questionnaire
• Scores over 14 on both the PHQ-9 and GAD-7 questionnaire
• In screener, indicates she has "death ideation" ("yes" response on question 14)

Related Conditions & MeSH terms

• Contraceptive Usage
• Depression
• Depression, Postpartum

Intervention

Behavioral:
• Mother's Time
Mother's Time is an evidence-based cognitive behavioral therapy (CBT) tool designed to support postpartum women experiencing mild to moderate symptoms of stress, depression, or anxiety. The intervention is designed for use by Ethiopian community health workers (CHWs) and includes CBT exercises and discussion on topics relating to family planning, such as planning for the future, speaking to the husband, and considering potential side effects.

Locations

Country	Name	City	State
Ethiopia	Health centers/clusters in selected woredas	West Gojjam	Amhara

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Camber Collective, DeepDive Consulting, Johns Hopkins Center for Communication Programs, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postpartum depression	Symptoms of depression using Patient Health Questionnaire-9 (PHQ-9). This is a 9-item questionnaire with scores for each question ranging from 0 (not at all) to 3 (nearly every day). Scores are summed for an overall score range of 0-27, with higher scores meaning more greater depression severity.	Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Primary	Change in postpartum anxiety	Symptoms of anxiety using General Anxiety Disorder-7 (GAD-7). This is a 7-item questionnaire with scores for each question ranging from 0 (not at all) to 3 (nearly every day). Scores are summed for an overall score range of 0-21, with higher scores meaning more greater anxiety severity.	Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Primary	Change in postpartum family planning	Current use of modern contraception method postpartum (yes vs. no)	Baseline, Endline up to 1 month post-intervention, 3-month follow-up