Perinatal DepressionNCT07380061
Peer Mentor Texting
A study testing Peer mentor texting in people with Perinatal Depression and Perinatal Anxiety, run by University of Washington at 1 site in United States.
Trial summary
This study tested whether a peer mentor text message program (called the Nurture program) could help support mental health during pregnancy and after birth. In the study, 127 pregnant people in Washington state were randomly placed to in one of two groups: Nurture group - could text with a trained peer mentor and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Perinatal Anxiety, Parenting Stress
- What is being tested?
- Peer mentor texting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 4 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women and other birthing individuals receiving prenatal care within Washington.
Who cannot join
- Severe mental illness such as bipolar disorder and schizophrenia and severe substance use disorder based on self report.
- Severe depression symptomology operationalized as PHQ-9 score 20 or higher.
- Severe suicidality (a response of "Nearly every day" to question 9, "Over the last 2 weeks, how often have you been bothered by any of the following problems?: Thoughts that you would be better off dead or of hurting yourself in some way." on the PHQ-9 questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effectiveness of a Bidirectional Peer - Mentor Text Messaging Intervention to Promote Perinatal Mental Health: A Pilot Randomized Trial
This study tested whether a peer mentor text message program (called the Nurture program) could help support mental health during pregnancy and after birth. In the study, 127 pregnant people in Washington state were randomly placed to in one of two groups: Nurture group - could text with a trained peer mentor and Control group got automated informational text messages. Researchers looked at how much participants used the program and whether it affected symptoms of depression, anxiety and stress related to parenting. Most people in the Nurture group actively used the program. Nearly all responded to their mentor and there was an average of 32 back and forth text conversations. Mentors usually started more conversations than participants did. People using Nurture had lower anxiety six weeks after giving birth compared to the control group. However there were no statistically significant differences between the two groups for depression or parenting stress. The findings suggest that having two way text conversations with peer mentors is well received and may help reduce anxiety soon after birth. More research with larger groups is needed to understand the full benefits and how to make the program widely available.
- Conditions
- Perinatal Depression, Perinatal Anxiety, Parenting Stress
- Being tested
- Peer mentor texting, Control
- Keywords
- perinatal mental health, text messaging, peer support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentor textingBehavioural
If assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities.
ControlBehavioural
If assigned to the control arm, the participant received automated informational texts throughout the period of participation. Participants could not respond to these texts. Information content that is publicly available such as the Babycenter's pregnancy stage information the Washington State Department of Children, Youth, and Families (DCYF) information packets about infant development and milestones as well as various ways to encourage learning and healthy development was used.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | If assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities. Receives: Behavioral: Peer mentor texting |
| Control | Active comparator | Participants receive automated interventional texts Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms over time as measured by the PHQ-9
Depressive symptoms in pregnancy and postpartum measured using the Patient Health Questionnaire -9 (PHQ-9). Score range 0 to 27, with higher scores meaning worse depression.
Measured: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Change from baseline in anxiety symptoms over time, as measured by GAD-7.
Anxiety during pregnancy and postpartum, measured using the Generalized Anxiety disorder Scale (GAD-7). Score range from 0 to 27 with higher scores meaning worse anxiety
Measured: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Change from baseline to 9 months in Parenting Stress as measured by the Parenting Stress Scale
Parenting Stress measured using the Parenting Stress Scale. An 18 - item self report scale - items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Overall possible scores on the scale range from 18 - 90. The higher the score , the higher the measured level of Parental stress
Measured: 6 weeks and 9 months postpartum.
Feasibility of enrolment as measured by number of participants enrolled
Ability to enroll into the study
Measured: Baseline
Intervention engagement as measured by number of messages exchanged
Engagement measured by number of messages exchanged
Measured: Baseline, 9 months postpartum
Secondary outcomes (4)
Change from baseline in General Wellbeing over time as measured by the General Wellbeing Schedule
Measure of wellbeing, score range 0 - 110, higher scores indicating higher wellbeing.
Measured: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Change in Maternal self efficacy from baseline over time as measures by the Self Efficacy in a Nurturing Role questionnaire.
Parenting self efficacy measured during pregnancy and postpartum, using the Self Efficacy in a Nurturing Role questionnaire.16 items, score range 16 - 112, higher scores represent higher self efficacy.
Measured: Baseline, 6 weeks and 9 months postpartum.
Change in wellbeing from baseline to 9 months as measured by the Flourishing scale
Measure of wellbeing. Score range is 8 to 56, with higher scores representing a person with many psychological resources and strengths.
Measured: Baseline and 9 months postpartum.
Social support
Social support measured using Multidimensional scale of perceived social support (MSPSS). The MSPSS a 12-item self-report questionnaire that measures perceived support from family, friends, and significant others.
Score Range 12 to 84, low scores indicating low support and high scores indicating high support.
Measured: Baseline, 3 months and 9 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start12 Jan 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amritha Subray Bhat, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380061
- Sponsor's protocol ID
- STUDY00013616
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of a Bidirectional Peer - Mentor Text Messaging Intervention to Promote Perinatal Mental Health: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07380061
- Acronym / sponsor ID
- STUDY00013616
- Conditions
- Perinatal Depression, Perinatal Anxiety, Parenting Stress
- Keywords
- perinatal mental health, text messaging, peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 2 Feb 2026 (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.
This study tested whether a peer mentor text message program (called the Nurture program) could help support mental health during pregnancy and after birth. In the study, 127 pregnant people in Washington state were randomly placed to in one of two groups: Nurture group - could text with a trained peer mentor and Control group got automated informational text messages. Researchers looked at how much participants used the program and whether it affected symptoms of depression, anxiety and stress related to parenting. Most people in the Nurture group actively used the program. Nearly all responded to their mentor and there was an average of 32 back and forth text conversations. Mentors usually started more conversations than participants did. People using Nurture had lower anxiety six weeks after giving birth compared to the control group. However there were no statistically significant differences between the two groups for depression or parenting stress. The findings suggest that having two way text conversations with peer mentors is well received and may help reduce anxiety soon after birth. More research with larger groups is needed to understand the full benefits and how to make the program widely available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Peer mentor textingIf assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities. |
| Control | Active comparator | Behavioral: ControlParticipants receive automated interventional texts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women and other birthing individuals receiving prenatal care within Washington.
Key exclusion criteria (3 listed)
- Severe mental illness such as bipolar disorder and schizophrenia and severe substance use disorder based on self report.
- Severe depression symptomology operationalized as PHQ-9 score 20 or higher.
- Severe suicidality (a response of "Nearly every day" to question 9, "Over the last 2 weeks, how often have you been bothered by any of the following problems?: Thoughts that you would be better off dead or of hurting yourself in some way." on the PHQ-9 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 |
|---|---|---|
| Peer mentor textingIf assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities. | Behavioural | Intervention |
| ControlIf assigned to the control arm, the participant received automated informational texts throughout the period of participation. Participants could not respond to these texts. Information content that is publicly available such as the Babycenter's pregnancy stage information the Washington State Department of Children, Youth, and Families (DCYF) information packets about infant development and milestones as well as various ways to encourage learning and healthy development was used. | Behavioural | Control |
Primary outcome
Change from baseline in depressive symptoms over time as measured by the PHQ-9
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Depressive symptoms in pregnancy and postpartum measured using the Patient Health Questionnaire -9 (PHQ-9). Score range 0 to 27, with higher scores meaning worse depression.
Change from baseline in anxiety symptoms over time, as measured by GAD-7.
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Anxiety during pregnancy and postpartum, measured using the Generalized Anxiety disorder Scale (GAD-7). Score range from 0 to 27 with higher scores meaning worse anxiety
Change from baseline to 9 months in Parenting Stress as measured by the Parenting Stress Scale
Time frame: 6 weeks and 9 months postpartum.
Parenting Stress measured using the Parenting Stress Scale. An 18 - item self report scale - items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Overall possible scores on the scale range from 18 - 90. The higher the score , the higher the measured level of Parental stress
Feasibility of enrolment as measured by number of participants enrolled
Time frame: Baseline
Ability to enroll into the study
Intervention engagement as measured by number of messages exchanged
Time frame: Baseline, 9 months postpartum
Engagement measured by number of messages exchanged
4 secondary outcomes
Change from baseline in General Wellbeing over time as measured by the General Wellbeing Schedule
Time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Change in Maternal self efficacy from baseline over time as measures by the Self Efficacy in a Nurturing Role questionnaire.
Time frame: Baseline, 6 weeks and 9 months postpartum.
Change in wellbeing from baseline to 9 months as measured by the Flourishing scale
Time frame: Baseline and 9 months postpartum.
Social support
Time frame: Baseline, 3 months and 9 months postpartum.
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentor texting in people with Perinatal Depression and Perinatal Anxiety, run by University of Washington at 1 site in United States.
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 1 inclusion and 3 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 2 Feb 2026. 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 United States. 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 from baseline in depressive symptoms over time as measured by the PHQ-9 (time frame: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.). The study lists 5 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 2 Feb 2026.