Safety Aid Reduction Treatment for PTSD Among Veterans (START-PTSD)

VA Office of Research and Development

Status: Completed

Conditions: Stress Disorders, Post-Traumatic

Treatments: Behavioral: Safety Aid Reduction Treatment for PTSD

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04515784

MHBP-003-19F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veterans receiving care at New Orleans VA
• Veterans with diagnosis of PTSD who decline trauma focused treatment

Exclusion criteria

• Substance dependence requiring detoxification
• Active psychosis
• Uncontrolled Bipolar Disorder
• Severe suicidal intent requiring hospitalization
• Current engagement in psychotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Active

Experimental group

Description:

Active arm- START-PTSD

Treatment:

Behavioral: Safety Aid Reduction Treatment for PTSD