Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-01-01
2027-08-31
Brief Summary
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The main questions it aims to answer are:
• Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention?
Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation.
Participants will:
* Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms.
* Receive check-ins with a Peer Guide (in the Peer Guide condition only)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Services as Usual
Services as usual received by referral or identified by the participant
No interventions assigned to this group
Along With Me Web-Based Intervention
Web-based tool that offers therapeutic support modules with information that leverages cognitive behavioral therapy and mindfulness strategies. The web-based tool includes 10 modules and also includes a list of resources and journaling feature.
Along With Me
Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.
Along With Me Web-Based Intervention Plus Peer Guide Support
Web-based tool plus support from a Peer Guide.
Along With Me
Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.
Peer Guide
The peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers.
Interventions
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Along With Me
Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.
Peer Guide
The peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers.
Eligibility Criteria
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Inclusion Criteria
* Reside in the United State
* Speak and read either English or Spanish at a 6th grade reading level
* 15 or older
Exclusion Criteria
* Does not reside in the United State
* Does not speak and read either English or Spanish at a 6th grade reading level
* 14 or younger
15 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Oregon Research Behavioral Intervention Strategies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David R Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Research Behavioral Intervention Strategies, Inc.
Locations
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Oregon Research Behavioral Strategies, Inc.
Springfield, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MH126788-02
Identifier Type: -
Identifier Source: org_study_id