NCT03846115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

February 17, 2019

Last Update Submit

December 29, 2022

Conditions

Substance Use DisordersPTSDTraumaEmotional Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Change in substance use on the Brief Addiction Monitor

    Past 30 days substance use and related problems

    Baseline, end of intervention (12 weeks), 3 months after end of intervention

  • Change in trauma symptoms

    Trauma Symptom Checklist 40

    Baseline, end of intervention (12 weeks), 3 months after end of intervention

Secondary Outcomes (2)

  • Amount of time spent on the app

    Baseline, end of intervention (12 weeks)

  • Change in coping self-efficacy on the Coping Self-Efficacy Scale

    Baseline, end of intervention (12 weeks), 3 months after end of intervention

Study Arms (2)

Peer-Led Seeking Safety app

EXPERIMENTAL

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

Behavioral: Peer-Led Seeking Safety app

Control app

ACTIVE COMPARATOR

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

Behavioral: Control app

Interventions

Peer-Led Seeking Safety appBEHAVIORAL

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

Peer-Led Seeking Safety app
Control appBEHAVIORAL

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

Control app

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • current uncontrolled psychotic or bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Innovations

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Lisa Najavits, PhD

    Treatment Innovations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 19, 2019

Study Start

October 1, 2020

Primary Completion

July 8, 2022

Study Completion

July 8, 2022

Last Updated

January 3, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)