Efficacy of Mother's Time in Ethiopia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Depression, Postpartum, Anxiety, Postpartum, Contraceptive Usage

Intervention / Treatment
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* Behavioral: Mother's Time


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a cluster-randomized parallel intervention study model. Following random assignment of clusters to either the intervention or control arm and subsequent recruitment of participants, individuals will be enrolled in the study. Intervention arm: Mother's Time intervention Control arm: Standard of care Clusters will be randomly assigned using a random number generator to either the intervention arm or the control arm. Then, all individuals recruited within a given cluster will be assigned to the same intervention condition. Anticipating that the Mother's Time intervention will be superior to the standard care with respect to reducing symptoms of stress, depression, and anxiety and increasing modern contraceptive use, women in the control group will have opportunity to receive the full intervention upon completion of the intervention to the intervention group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mother's Time Intervention<br>Working with local research partners, the research team will train HEWs in the intervention clusters in the Amhara region of Ethiopia to deliver four intervention sessions in a group setting of approximately six to eight women (average: 7). These sessions will take place over a period of approximately one month. Participants in the intervention group will receive four sessions of Mother's Time, delivered by an HEW. | Behavioral: Mother's Time<br>* 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.<br>|
| No Intervention: Standard of care<br>Participants in the control group will receive the standard of care that postpartum mothers in Ethiopia receive. Standard of care for postpartum mothers related to family planning and mental health in Ethiopia includes multiple touch points that correspond with postpartum care as well as routine immunization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum depression, Postpartum anxiety, Postpartum family planning