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A Mobile App for Peer-led Seeking Safety

A Technology Solution for Peer-led Seeking Safety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03846115
Enrollment
130
Registered
2019-02-19
Start date
2020-10-01
Completion date
2022-07-08
Last updated
2023-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Dysfunction, PTSD, Substance Use Disorders, Trauma

Brief summary

Peer support is historically prominent for substance use disorder (SUD), such as the world-wide model of Alcoholics Anonymous and other 12-step groups. Yet for trauma and posttraumatic stress disorder (PTSD) there have been few attempts at peer help. A major challenge of trauma peer groups is that they usually focus on telling the story of members' trauma histories, which can be overly triggering and distressing. Seeking Safety offers an excellent choice for peer-led care. It is an evidence-based and is the most widely adopted model for SUD/PTD. It is present-focused, cognitive-behavioral, and provides psychoeducation and coping skills to help clients attain greater safety in their lives. It has been successfully implemented in peer-led format for many years and has been studied in various trials, including a recent randomized controlled trial (RCT) comparing peer versus professional delivery, with positive results. In Phase 1 we developed a beta version of a mobile app for peer-led Seeking Safety (PLSS). In Phase 2 we will enhance the app features and content and also conduct an RCT in a sample of adults with current SUD/PTSD to compare the Peer Safety app condition to a control app.

Detailed description

Peers are increasingly recognized as an important asset in healthcare. Peer support is historically most prominent for substance use disorder (SUD), such as the world-wide model of Alcoholics Anonymous and other 12-step groups. Yet for trauma and posttraumatic stress disorder (PTSD) there have been few attempts at peer help. A major challenge of trauma peer groups is that they usually focus on telling the story of members' trauma histories, which can be overly triggering and distressing. Seeking Safety offers an excellent choice for peer-led care. It is an evidence-based and is the most widely adopted model for SUD/PTD. It is present-focused, cognitive-behavioral, and provides psychoeducation and coping skills to help clients attain greater safety in their lives-- safety from unsafe behavior toward themselves and others, substance use, and trauma symptoms. It has been successfully implemented in peer-led format for many years and has been studied in various trials, including a recent randomized controlled trial (RCT) comparing peer versus professional delivery, with positive results. In Phase 1 we developed a beta version of a mobile app for peer-led Seeking Safety (PLSS). The Peer Safety (PS) app was based on extensive input from end users and was evaluated in a feasibility study. We found strong positive results in Phase 1 and are now conducting a Phase 2 project to continue this work. In Phase 2 we are enhancing the app features and content and will also conduct an RCT in a sample of adults with current SUD/PTSD to compare the PS app condition to a control app. They will have 12 weeks to use the app and participate in weekly online PLSS, and will be assessed pre, post and at 3-month followup using validated instruments. We will also measure app usage and satisfaction. The primary outcomes are substance use and trauma symptoms. Our public health goal is to leverage technology to create PLSS in an online environment that would support recovery, powered by highly engaging content and delivery. The PS app could address the need for access in remote locations, for anonymous help, and for convenient, low-cost help, delivered by people who share their experiences as peers. Even for those who do attend in-person modalities, the app can provide additional support and unique features. This project proposes a novel technology solution to provide care for an important population-- people with SUD/PTSD.

Interventions

BEHAVIORALPeer-Led Seeking Safety app

This app offers participants sessions of Seeking Safety plus enhanced app features designed to engage and sustain participants in their recovery work.

BEHAVIORALControl app

This app offers the Seeking Safety content but without the enhanced features

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Treatment Innovations
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* meets DSM-5 criteria for current SUD and current PTSD (the latter either full or subthreshold) * has a mobile device, either Android or iOS.

Exclusion criteria

* current uncontrolled psychotic or bipolar disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in substance use on the Brief Addiction MonitorBaseline, end of intervention (12 weeks), 3 months after end of interventionPast 30 days substance use and related problems
Change in trauma symptomsBaseline, end of intervention (12 weeks), 3 months after end of interventionTrauma Symptom Checklist 40

Secondary

MeasureTime frameDescription
Amount of time spent on the appBaseline, end of intervention (12 weeks)App usage data
Change in coping self-efficacy on the Coping Self-Efficacy ScaleBaseline, end of intervention (12 weeks), 3 months after end of interventionHigher scores indicate stronger perceived ability to cope with challenges; scaling is 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). An overall score is computed by summing all items.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026