Clinical trial NCT03846115: A Mobile App for Peer-led Seeking Safety
Official title: A Technology Solution for Peer-led Seeking Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
PTSD
Trauma
Emotional Dysfunction
Lead sponsor: Treatment Innovations
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in substance use on the Brief Addiction Monitor
timeFrame: Baseline, end of intervention (12 weeks), 3 months after end of intervention
measure: Change in trauma symptoms
timeFrame: Baseline, end of intervention (12 weeks), 3 months after end of intervention
Secondary outcomes:
measure: Amount of time spent on the app
timeFrame: Baseline, end of intervention (12 weeks)
measure: Change in coping self-efficacy on the Coping Self-Efficacy Scale
timeFrame: Baseline, end of intervention (12 weeks), 3 months after end of intervention
Other outcomes:
Locations:
city: Newton
country: United States
facility: Treatment Innovations
state: Massachusetts
Study officials:
affiliation: Treatment Innovations
name: Lisa Najavits, PhD
role: PRINCIPAL_INVESTIGATOR
References: