[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06746337":3,"trial-entities:NCT06746337":84,"trial-summary:NCT06746337":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":63,"locations":67,"central_contacts":77,"overall_officials":78,"references":82,"see_also_links":83},"NCT06746337","STUDY00019195","IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression","ACTIVE_NOT_RECRUITING","2026-10-31","2026-05","2026-05-26","2025-03-10","University of Washington","OTHER",false,"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:\n\nDoes IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible?\n\nParticipants 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.","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.\n\nThe proposal consists of 3 specific aims:\n\nAim 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:\n\n1. 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.\n2. IMAGINE implementation protocols and materials to support delivery by our implementation partner.\n\nHypothesis: Combined synchronous and asynchronous content and delivery compliant with billable health services will be preferred.\n\nAim 2. Determine IMAGINE's preliminary effectiveness engaging CBT targets and preventing depression.\n\nA 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\u002Fethnicity, pregnancy status, and language.\n\nHypothesis: IMAGINE will lead to moderate reduction in depression symptoms, with effect size similar to MB.\n\nAim 3. Determine IMAGINE's preliminary implementation outcomes (acceptability, appropriateness, usability, and feasibility) among client, provider, administrator, and payer stakeholders.\n\nAcceptability, 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.",[18,19],"Depression During Pregnancy","Depression, Postpartum",[21,22,23],"digital","perinatal","depression","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},100,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","IMAGINE","IMAGINE is a digital group cognitive behavioral therapy intervention",[34],[38],{"measure":39,"description":40,"timeFrame":41},"Depression symptoms","Ascertained by Beck Depression Inventory (score 0-63, higher score means worse outcome)","24 weeks",[43,45],{"measure":39,"description":44,"timeFrame":41},"Ascertained by Patient Health Questionnaire 9 (score 0-27, higher score means worse outcome)",{"measure":46,"description":47,"timeFrame":41},"Anxiety symptoms","Ascertained by Generalized Anxiety Disorder 7 (score 0-21, higher score means worse outcome)","FEMALE","16 Years",null,true,{"inclusion":53,"exclusion":61,"raw_text":62},[54,55,56,57,58,59,60],"Pregnant or up to 6 months postpartum","Age 16 or over","At elevated risk of perinatal depression (per USPSTF)","Speaks English or Spanish","PHQ9\\\u003C15 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",[],"Inclusion Criteria:\n\n* Pregnant or up to 6 months postpartum\n* Age 16 or over\n* At elevated risk of perinatal depression (per USPSTF)\n* Speaks English or Spanish\n* PHQ9\\\u003C15 and no current major depression\n* Access to a smartphone with cellular data at least 3 days per week\n* If receiving other mental healthcare services, has been established in care at least 6 months and on stable treatment regimen\n\nExclusion Criteria: none",[64,65,66],"CHILD","ADULT","OLDER_ADULT",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Perinatal Support Washington","Seattle","Washington","98103","United States",{"lat":75,"lon":76},47.60621,-122.33207,[],[79],{"name":80,"affiliation":12,"role":81},"Keshet Ronen, PhD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Depression",[],{"nct_id":4,"found":51,"summary":89,"prompt_version":99},{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an interventional study where participants will be randomly assigned to either the IMAGINE group or standard care. It plans to enroll 100 women.","completed","IMAGINE: Digital Group Intervention to Prevent Perinatal Depression","This study is testing a digital group program called IMAGINE to see if it can help prevent depression during pregnancy and after childbirth (perinatal depression). IMAGINE uses cognitive behavioral therapy (a type of talk therapy) delivered online. Researchers want to know if IMAGINE helps reduce depression symptoms, if people find it acceptable and easy to use, and if it works as intended. You could join if you are pregnant or up to 6 months postpartum, are at least 16 years old, speak English or Spanish, and are at higher risk for perinatal depression but don't currently have severe depression. Participants will either join an IMAGINE group for 12 weeks or receive standard care. The study is currently unclear on its recruitment status and aims to enroll 100 participants.","Participants will be followed for 24 weeks after enrollment to measure depression symptoms.",128,"You would respond to questionnaires when you join and at follow-up visits 12 and 24 weeks after enrollment. If in the IMAGINE group, you would participate for 12 weeks.","Not stated in the trial record.",[34],"v2"]