NCT04515784

Safety Aid Reduction Treatment for PTSD Among Veterans

Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.

Detailed description

Rates of posttraumatic stress disorder (PTSD) among military personnel have surged in recent years. In response, the Department of Veterans Affairs (VA) has launched nationwide training initiatives to disseminate two PTSD treatments with strong empirical support: prolonged exposure (PE) therapy and cognitive processing therapy (CPT). Despite the well-documented effectiveness of PE and CPT, only a minority of Veterans with PTSD initiate these trauma-focused treatments. One approach to addressing PTSD in a non-trauma-focused fashion is to utilize empirically supported treatments focused on safety aid reduction. Safety aids are maladaptive cognitive and/or behavioral strategies designed to prevent, avoid, or alleviate anxiety. Initially introduced as a way to explain how pathological anxiety can persist despite repeated exposure to feared stimuli, safety aids have been found to play a critical role in the etiology and maintenance of various anxiety and related conditions including PTSD. Importantly, a separate line of research suggests that safety aids are amenable to change through cognitive behavioral interventions. Although promising, these trials did not include patients with PTSD. In this context, the purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) for PTSD. Participants will include veterans with a diagnosis of PTSD who decline to participate in evidence-based psychotherapies (EBPs) for PTSD, namely PE or CPT. It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
BEHAVIORAL	Safety Aid Reduction Treatment for PTSD	START-PTSD includes many of the key elements found in empirically supported treatments for PTSD including: a) psychoeducation regarding the development and maintenance of PTSD; and b) exposure to internal sensations and external situations that are connected to one's fear/distress response via identification and elimination of safety aids. Known safety aids to be covered include: cognitive avoidance (e.g., using mental distractions to avoid trauma-related images); situational avoidance (e.g., avoiding crowded market places); checking behaviors (e.g., checking doors, windows, locks, and perimeters more often than necessary); reassurance seeking (e.g., excessively watching the news); other compulsive behaviors (e.g., checking the location of exits); use of companions (e.g., relying on someone to attend a social gathering); and use of alcohol and certain substances (e.g., consuming alcohol to reduce anxiety).

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-09-29
• Completion: 2025-09-30
• First posted: 2020-08-17
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States