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A Mobile App for Peer-led Seeking Safety

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ClinicalTrials.gov Identifier: NCT03846115
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Treatment Innovations

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders PTSD Trauma Emotional Dysfunction Behavioral: Peer-Led Seeking Safety app Behavioral: Control app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Technology Solution for Peer-led Seeking Safety
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Peer-Led Seeking Safety app
This app is designed for Peer-Led Seeking Safety and includes enhanced app features.
Behavioral: Peer-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.

Active Comparator: Control app
This is a basic app that controls for time and attention. The basic app serves as the intervention in this trial.
Behavioral: Control app
This app offers the Seeking Safety content but without the enhanced features




Primary Outcome Measures :
  1. Change in substance use on the Brief Addiction Monitor [ Time Frame: Baseline, end of intervention (12 weeks), 3 months after end of intervention ]
    Past 30 days substance use and related problems

  2. Change in trauma symptoms [ Time Frame: Baseline, end of intervention (12 weeks), 3 months after end of intervention ]
    Trauma Symptom Checklist 40


Secondary Outcome Measures :
  1. Amount of time spent on the app [ Time Frame: Baseline, end of intervention (12 weeks) ]
    App usage data

  2. Change in coping self-efficacy on the Coping Self-Efficacy Scale [ Time Frame: Baseline, end of intervention (12 weeks), 3 months after end of intervention ]
    Higher 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846115


Contacts
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Contact: Lisa Najavits, PhD 617-299-1620 director@treatment-innovations.org
Contact: Jamie Miller 617-299-1610 coordinator@treatment-innovations.org

Locations
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United States, Massachusetts
Treatment Innovations
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Treatment Innovations
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lisa Najavits, PhD Treatment Innovations

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Responsible Party: Treatment Innovations
ClinicalTrials.gov Identifier: NCT03846115     History of Changes
Other Study ID Numbers: 2R44DA041949-02 ( U.S. NIH Grant/Contract )
2R44DA041949-02 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders