Depression, PostpartumNCT05806463
Efficacy of Mother's Time in Ethiopia
A study testing Mother's Time in people with Depression, Postpartum and Anxiety, Postpartum, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women only
- Conditions the study is for
- Depression, Postpartum, Anxiety, Postpartum, Contraceptive Usage
- What is being tested?
- Mother's Time
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteEthiopia
- Study dates
- 4 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Health centers/clusters in selected woredas
West Gojjam, Amhara
About this study
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
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.
Read the 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:
- 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.
- 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.
- Explore feasibility and acceptability of implementing Mothers Time from the perspective of health extension workers (HEWs) and HEW supervisors.
- Being tested
- Mother's Time
- Keywords
- Postpartum depression, Postpartum anxiety, Postpartum family planning
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother's TimeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mother's Time Intervention | Experimental | 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. Receives: Behavioral: Mother's Time |
| Standard of care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start4 May 2023
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins Center for Communication Programs, Camber Collective, DeepDive Consulting
- Responsible party
- Sponsor
- Investigators
- Stella Babalola, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806463
- Sponsor's protocol ID
- 23020
- Status last verified
- Jan 2024
- First submitted
- 28 Mar 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators plan to share summary reports and presentations about this research project and results in presentations to the investigators' funder, USAID, local partners, the Ethiopian Ministry of Health and other stakeholders working in family planning, mental health, or maternal health. All shared information will be at the summary level and not provide any identifiable information. The investigators also plan to publish peer-reviewed articles and international comments which will not include any identifiable information. If journal reviewers request data, the investigators will provide high-level, aggregated descriptive statistics on our participants from the quantitative data, but will not share full datasets or transcripts outside the study team. As these data are related to a potentially sensitive topic, they will not be made publicly available. Due to the relatively small sample size, making data publicly available could create risks around confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05806463
- Acronym / sponsor ID
- 23020
- Keywords
- Postpartum depression, Postpartum anxiety, Postpartum family planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins Center for Communication Programs, Camber Collective, DeepDive Consulting
- Study start
- 4 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Explore feasibility and acceptability of implementing Mothers Time from the perspective of health extension workers (HEWs) and HEW supervisors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mother's Time Intervention | Experimental | Behavioral: Mother's TimeWorking 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. |
| Standard of care | No intervention | –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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother's TimeMother'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. | Behavioural | Mother's Time Intervention |
Primary outcome
Change in postpartum depression
Time frame: 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
Time frame: 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
Time frame: Baseline, Endline up to 1 month post-intervention, 3-month follow-up
Current use of modern contraception method postpartum (yes vs. no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No. The investigators plan to share summary reports and presentations about this research project and results in presentations to the investigators' funder, USAID, local partners, the Ethiopian Ministry of Health and other stakeholders working in family planning, mental health, or maternal health. All shared information will be at the summary level and not provide any identifiable information. The investigators also plan to publish peer-reviewed articles and international comments which will not include any identifiable information. If journal reviewers request data, the investigators will provide high-level, aggregated descriptive statistics on our participants from the quantitative data, but will not share full datasets or transcripts outside the study team. As these data are related to a potentially sensitive topic, they will not be made publicly available. Due to the relatively small sample size, making data publicly available could create risks around confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stella Babalola, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother's Time in people with Depression, Postpartum and Anxiety, Postpartum, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postpartum depression (time frame: Baseline, Endline up to 1 month post-intervention, 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.