Depression During PregnancyNCT06746337
IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
A study testing IMAGINE in people with Depression During Pregnancy and Depression, Postpartum, run by University of Washington at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression During Pregnancy, Depression, Postpartum
- What is being tested?
- IMAGINE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant or up to 6 months postpartum
- Age 16 or over
- At elevated risk of perinatal depression (per USPSTF)
- Speaks English or Spanish
- PHQ9<15 and no current major depression
- Access to a smartphone with cellular data at least 3 days per week
- If receiving other mental healthcare services, has been established in care at least 6 months and on stable treatment regimen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perinatal Support Washington
Seattle, Washington, 98103
About this study
The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are:
Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible?
Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment.
Read the detailed description
Perinatal depression affects an estimated 13% of pregnant people in the US. While effective interventions exist to prevent perinatal depression, access to facility-based in-person interventions is limited. This proposal will refine a digital group adaptation of an evidence-based prevention intervention, and evaluate its preliminary effectiveness and implementation outcomes through a pilot randomized controlled trial.
The proposal consists of 3 specific aims:
Aim 1. Using human-centered design, refine the IMAGINE intervention for implementation within perinatal mental health services in Washington State. Building off existing IMAGINE intervention materials, we will conduct qualitative interviews and focus groups with perinatal people, service providers, administrators, and payers to refine:
- IMAGINE intervention design to meet the needs of perinatal clients age 16-35. Components to be optimized include message frequency, balance of synchronous and asynchronous content, and group composition.
- IMAGINE implementation protocols and materials to support delivery by our implementation partner.
Hypothesis: Combined synchronous and asynchronous content and delivery compliant with billable health services will be preferred.
Aim 2. Determine IMAGINE's preliminary effectiveness engaging CBT targets and preventing depression.
A pilot RCT will be conducted comparing IMAGINE (as optimized in Aim 1) delivered in English or Spanish vs. treatment as usual, among 100 perinatal participants (pregnant or ≤6 months postpartum) with one or more risk factors for perinatal depression (as defined by USPSTF) and no current major depression. Participants will be recruited from our partner organization's clients. We will compare longitudinal change in depression symptoms and engagement of target mechanisms (negative mood regulation, perceived stress, and perceived social support) between arms at enrollment, 12- and 24-weeks post-enrollment. Exploratory analyses will assess effect modification by participant age, race/ethnicity, pregnancy status, and language.
Hypothesis: IMAGINE will lead to moderate reduction in depression symptoms, with effect size similar to MB.
Aim 3. Determine IMAGINE's preliminary implementation outcomes (acceptability, appropriateness, usability, and feasibility) among client, provider, administrator, and payer stakeholders.
Acceptability, appropriateness and usability among RCT participants will be assessed based on quantitative questionnaires, engagement in IMAGINE, and qualitative interviews. Provider, administrator, and payer acceptability, feasibility, and appropriateness will be determined through group discussion of IMAGINE RCT process indicators. We will explore client and contextual determinants of implementation outcomes.
- Being tested
- IMAGINE
- Keywords
- digital, perinatal, depression
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAGINEBehavioural
IMAGINE is a digital group cognitive behavioral therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| IMAGINE | Experimental | The intervention is a digital adaptation of the evidence-based Mothers and Babies program, delivered interactively to groups of perinatal people and facilitated by a mental health provider. Receives: Behavioral: IMAGINE |
| Control | No intervention | Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Ascertained by Beck Depression Inventory (score 0-63, higher score means worse outcome)
Measured: 24 weeks
Secondary outcomes (2)
Depression symptoms
Ascertained by Patient Health Questionnaire 9 (score 0-27, higher score means worse outcome)
Measured: 24 weeks
Anxiety symptoms
Ascertained by Generalized Anxiety Disorder 7 (score 0-21, higher score means worse outcome)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start10 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression During PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Northwestern University, Brown University, Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Keshet Ronen, University of Washington
- Investigators
- Keshet Ronen, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746337
- Sponsor's protocol ID
- STUDY00019195
- Other IDs
- R34MH131571
- Status last verified
- May 2026
- First submitted
- 12 Dec 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project is required to deposit mental health outcomes data in the NIMH National Data Archive (NDA). NDA uses direct identifies to generate global unique identifiers, but the identifiers themselves will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
- ClinicalTrials.gov ID
- NCT06746337
- Acronym / sponsor ID
- STUDY00019195
- Keywords
- digital, perinatal, depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Northwestern University, Brown University, Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are:
Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible?
Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment.
Detailed description
Perinatal depression affects an estimated 13% of pregnant people in the US. While effective interventions exist to prevent perinatal depression, access to facility-based in-person interventions is limited. This proposal will refine a digital group adaptation of an evidence-based prevention intervention, and evaluate its preliminary effectiveness and implementation outcomes through a pilot randomized controlled trial.
The proposal consists of 3 specific aims:
Aim 1. Using human-centered design, refine the IMAGINE intervention for implementation within perinatal mental health services in Washington State. Building off existing IMAGINE intervention materials, we will conduct qualitative interviews and focus groups with perinatal people, service providers, administrators, and payers to refine:
- IMAGINE intervention design to meet the needs of perinatal clients age 16-35. Components to be optimized include message frequency, balance of synchronous and asynchronous content, and group composition.
- IMAGINE implementation protocols and materials to support delivery by our implementation partner.
Hypothesis: Combined synchronous and asynchronous content and delivery compliant with billable health services will be preferred.
Aim 2. Determine IMAGINE's preliminary effectiveness engaging CBT targets and preventing depression.
A pilot RCT will be conducted comparing IMAGINE (as optimized in Aim 1) delivered in English or Spanish vs. treatment as usual, among 100 perinatal participants (pregnant or ≤6 months postpartum) with one or more risk factors for perinatal depression (as defined by USPSTF) and no current major depression. Participants will be recruited from our partner organization's clients. We will compare longitudinal change in depression symptoms and engagement of target mechanisms (negative mood regulation, perceived stress, and perceived social support) between arms at enrollment, 12- and 24-weeks post-enrollment. Exploratory analyses will assess effect modification by participant age, race/ethnicity, pregnancy status, and language.
Hypothesis: IMAGINE will lead to moderate reduction in depression symptoms, with effect size similar to MB.
Aim 3. Determine IMAGINE's preliminary implementation outcomes (acceptability, appropriateness, usability, and feasibility) among client, provider, administrator, and payer stakeholders.
Acceptability, appropriateness and usability among RCT participants will be assessed based on quantitative questionnaires, engagement in IMAGINE, and qualitative interviews. Provider, administrator, and payer acceptability, feasibility, and appropriateness will be determined through group discussion of IMAGINE RCT process indicators. We will explore client and contextual determinants of implementation outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMAGINE | Experimental | Behavioral: IMAGINEThe intervention is a digital adaptation of the evidence-based Mothers and Babies program, delivered interactively to groups of perinatal people and facilitated by a mental health provider. |
| Control | No intervention | –Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant or up to 6 months postpartum
- Age 16 or over
- At elevated risk of perinatal depression (per USPSTF)
- Speaks English or Spanish
- PHQ9<15 and no current major depression
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IMAGINEIMAGINE is a digital group cognitive behavioral therapy intervention | Behavioural | IMAGINE |
Primary outcome
Depression symptoms
Time frame: 24 weeks
Ascertained by Beck Depression Inventory (score 0-63, higher score means worse outcome)
2 secondary outcomes
Depression symptoms
Time frame: 24 weeks
Anxiety symptoms
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. This project is required to deposit mental health outcomes data in the NIMH National Data Archive (NDA). NDA uses direct identifies to generate global unique identifiers, but the identifiers themselves will not be shared.
Related trials for Depression During Pregnancy
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Not yet recruiting
LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies
High-risk Pregnancy, Hospitalization
Not yet recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
RecruitingObservational study
Women's Reproductive Choices and Mental Health During Pregnancy and After Birth in Wartime Ukraine
Perinatal Mental Health, Reproductive Behavior
Active, not recruiting
A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
Depression, Antenatal Depression
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.
Keshet Ronen, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMAGINE in people with Depression During Pregnancy and Depression, Postpartum, 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 7 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 26 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression symptoms (time frame: 24 weeks). 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 26 May 2026.