Anxiety, Postpartum, Contraceptive Usage, Depression, Postpartum
Conditions
Keywords
Postpartum depression, Postpartum anxiety, Postpartum family planning
Brief 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.
Detailed 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.
Interventions
BEHAVIORALMother'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.
Sponsors
United States Agency for International Development (USAID)
Johns Hopkins Center for Communication Programs
Camber Collective
DeepDive Consulting
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will not be fully blinded to whether participants are in an intervention or control cluster. However, the use of a cluster-randomized approach reduces the risk of contamination among women from different clusters because it reduces the risk of communication between individuals in intervention and control arms. As HEWs will be responsible for assisting with recruitment of participants, HEWs will be aware of these eligibility criteria and who has been recruited for the study in both the control and intervention arms. As a result, HEWs will not be fully blinded to the study. Outcome assessors and statisticians will be blinded.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 24 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postpartum depression | Baseline, Endline up to 1 month post-intervention, 3-month follow-up | 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. |
| Change in postpartum anxiety | Baseline, Endline up to 1 month post-intervention, 3-month follow-up | 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. |
| Change in postpartum family planning | Baseline, Endline up to 1 month post-intervention, 3-month follow-up | Current use of modern contraception method postpartum (yes vs. no) |
Countries
Ethiopia
Outcome results
None listed