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A Mobile App for Peer-led Seeking Safety

Primary Purpose

Substance Use Disorders, PTSD, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Led Seeking Safety app
Control app
Sponsored by
Treatment Innovations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Treatment Innovations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer-Led Seeking Safety app

Control app

Arm Description

This app is designed for Peer-Led Seeking Safety and includes enhanced app features.

This is a basic app that controls for time and attention. The basic app serves as the intervention in this trial.

Outcomes

Primary Outcome Measures

Change in substance use on the Brief Addiction Monitor
Past 30 days substance use and related problems
Change in trauma symptoms
Trauma Symptom Checklist 40

Secondary Outcome Measures

Amount of time spent on the app
App usage data
Change in coping self-efficacy on the Coping Self-Efficacy Scale
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.

Full Information

First Posted
February 17, 2019
Last Updated
December 29, 2022
Sponsor
Treatment Innovations
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03846115
Brief Title
A Mobile App for Peer-led Seeking Safety
Official Title
A Technology Solution for Peer-led Seeking Safety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Innovations
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, PTSD, Trauma, Emotional Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-Led Seeking Safety app
Arm Type
Experimental
Arm Description
This app is designed for Peer-Led Seeking Safety and includes enhanced app features.
Arm Title
Control app
Arm Type
Active Comparator
Arm Description
This is a basic app that controls for time and attention. The basic app serves as the intervention in this trial.
Intervention Type
Behavioral
Intervention Name(s)
Peer-Led Seeking Safety app
Intervention Description
This app offers participants sessions of Seeking Safety plus enhanced app features designed to engage and sustain participants in their recovery work.
Intervention Type
Behavioral
Intervention Name(s)
Control app
Intervention Description
This app offers the Seeking Safety content but without the enhanced features
Primary Outcome Measure Information:
Title
Change in substance use on the Brief Addiction Monitor
Description
Past 30 days substance use and related problems
Time Frame
Baseline, end of intervention (12 weeks), 3 months after end of intervention
Title
Change in trauma symptoms
Description
Trauma Symptom Checklist 40
Time Frame
Baseline, end of intervention (12 weeks), 3 months after end of intervention
Secondary Outcome Measure Information:
Title
Amount of time spent on the app
Description
App usage data
Time Frame
Baseline, end of intervention (12 weeks)
Title
Change in coping self-efficacy on the Coping Self-Efficacy Scale
Description
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.
Time Frame
Baseline, end of intervention (12 weeks), 3 months after end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Najavits, PhD
Organizational Affiliation
Treatment Innovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treatment Innovations
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Mobile App for Peer-led Seeking Safety

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