Safety Aid Reduction Treatment for PTSD Among Veterans

NCT04515784 | Completed DMC

• 1 other identifier: MHBP-003-19F
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Safety aid; Treatment; Posttraumatic Stress Disorder; Veteran

Outcome Measures

Primary Outcomes (4)

• Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a 30-item clinician-administered interview designed to assess current (i.e., past month) and lifetime PTSD diagnostic status. In addition to assessing the 20 DSM-5 PTSD symptoms, the CAPS-5 contains questions regarding the onset and duration of symptoms, associated impairment in various life domains, and specifications for the dissociative subtype. The past month CAPS-5 will be administered at baseline and one-month follow-up to assess changes in PTSD diagnostic status.

  Baseline and one-month follow-up

• Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item self-report questionnaire designed to assess each of the 20 DSM-5 PTSD symptoms. Veterans will be asked to read a list of symptoms and indicate their level of distress as it relates to each within the past month using a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores reflecting increased symptom severity. The PCL-5 will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in PTSD symptom severity.

  Baseline, post-intervention (10-weeks), and one-month follow-up

• Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)

  The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Veterans will be asked to read a list of behaviors and rate how often they engage in each behavior using a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always) with higher scores reflecting increased symptom severity. The SBAF will be administered at baseline, immediately following the 10-week group, and at a one-month follow-up to assess changes in safety behavior usage.

  Baseline, post-intervention (10-weeks), and one-month follow-up

• Client Satisfaction Questionnaire-8 (CSQ-8)

  The CSQ-8 is an 8-item self-report questionnaire designed to assess overall satisfaction with treatment services. Although response options differ from item-to-item, all questions are rated on a 4-point Likert-type scale ranging from 1 to 4 with higher scores indicating higher treatment satisfaction. The CSQ-8 will be administered immediately following the 10-week group to assess treatment acceptability.

  Post-intervention (10-weeks)

Secondary Outcomes (4)

• Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)

  Baseline, post-intervention (10-weeks), and one-month follow-up

• Changes in depression as measured by the Beck Depression Inventory-II (BDI-II)

  Baseline, post-intervention (10-weeks), and one-month follow-up

• Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)

  Baseline, post-intervention (10-weeks), and one-month follow-up

• Changes in funtional impairment as measured by the Sheehan Disability Scale (SDS)

  Baseline, post-intervention (10-weeks), and one-month follow-up

Study Arms (1)

Active

EXPERIMENTAL

Active arm- START-PTSD

Behavioral: Safety Aid Reduction Treatment for PTSD

Interventions

Safety Aid Reduction Treatment for PTSD BEHAVIORAL

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).

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

Location

Related Publications (7)

• Rosen CS, Bernardy NC, Chard KM, Clothier B, Cook JM, Crowley J, Eftekhari A, Kehle-Forbes SM, Mohr DC, Noorbaloochi S, Orazem RJ, Ruzek JI, Schnurr PP, Smith BN, Sayer NA. Which patients initiate cognitive processing therapy and prolonged exposure in department of veterans affairs PTSD clinics? J Anxiety Disord. 2019 Mar;62:53-60. doi: 10.1016/j.janxdis.2018.11.003. Epub 2018 Nov 20.

  PMID: 30550959 BACKGROUND

• Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2.

  PMID: 20546985 BACKGROUND

• Dunmore E, Clark DM, Ehlers A. Cognitive factors involved in the onset and maintenance of posttraumatic stress disorder (PTSD) after physical or sexual assault. Behav Res Ther. 1999 Sep;37(9):809-29. doi: 10.1016/s0005-7967(98)00181-8.

  PMID: 10458046 BACKGROUND

• Riccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.

  PMID: 27397584 BACKGROUND

• Schmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.

  PMID: 22697441 BACKGROUND

• Monson CM, Schnurr PP, Resick PA, Friedman MJ, Young-Xu Y, Stevens SP. Cognitive processing therapy for veterans with military-related posttraumatic stress disorder. J Consult Clin Psychol. 2006 Oct;74(5):898-907. doi: 10.1037/0022-006X.74.5.898.

  PMID: 17032094 BACKGROUND

• Fulton JJ, Calhoun PS, Wagner HR, Schry AR, Hair LP, Feeling N, Elbogen E, Beckham JC. The prevalence of posttraumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans: a meta-analysis. J Anxiety Disord. 2015 Apr;31:98-107. doi: 10.1016/j.janxdis.2015.02.003. Epub 2015 Feb 19.

  PMID: 25768399 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Amanda M Raines, PhD

  Southeast Louisiana Veterans Health Care System, New Orleans, LA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: One-arm trial

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 17, 2020
• Study Start: September 23, 2024
• Primary Completion: September 29, 2025
• Study Completion: September 30, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)