Safety Aid Reduction Treatment for PTSD Among Veterans

Stress Disorders, Post-Traumatic Clinical Trial

— START-PTSD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04515784
• Other study ID #: MHBP-003-19F
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Amanda M Raines, PhD
• Phone: (504) 507-2000
• Email: amanda.raines[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to examine the efficacy of a safety aid reduction treatment (START), compared to a wait-list control, among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that participation in START, compared to a wait-list control, will be associated with decreased PTSD symptom severity immediately and over time.

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 efficacy of a safety aid reduction treatment (START), compared to a wait-list control. 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 participation in START, compared to a wait-list control, will be associated with decreased PTSD symptom severity immediately and over time.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: September 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
United States	Southeast Louisiana Veterans Health Care System, New Orleans, LA	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 or wait-list period, and at a one-month follow-up to assess changes in PTSD symptom severity.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Primary	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 or wait-list period, and at a one-month follow-up to assess changes in safety behavior usage.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Primary	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 or wait-list period to assess treatment acceptability.	Post-intervention or wait-list (10-weeks)
Secondary	Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)	The BAI is a 21-item self-report questionnaire designed to assess the experience of anxiety symptoms. Veterans will be asked to rate how often they experience each symptom using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Severely) with higher scores reflecting increased symptom severity. The BAI will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in anxiety symptoms.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Secondary	Changes in depression as measured by the Beck Depression Inventory-II (BDI-II)	The BDI-II is a 21-item self-report questionnaire designed to assess symptoms associated with depression. Using a 4-point Likert-type scale ranging from 0 to 3, Veterans will be asked to select the statement from a group of statements that best represents how they have felt over the last two weeks with higher scores reflecting increased symptom severity. The BDI-II will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in depression symptoms.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Secondary	Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)	The PTCI is a 33-item self-report questionnaire designed to assess trauma-related thoughts and beliefs including negative cognitions regarding the self, others, and the world. Veterans will be asked to read a list of statements and indicate the degree to which they agree or disagree with each statement using a 7-point Likert-type scale ranging from 1(totally disagree) to 7 (totally agree) with higher scores reflecting increased symptom severity. The PTCI will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in PTSD cognitions.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Secondary	Changes in funtional impairment as measured by the Sheehan Disability Scale (SDS)	The SDS is a 3-item self-report questionnaire designed to assess functional impairment functional impairment in work/school, social, and family life. For each domain, Veterans will be asked to provide an impairment rating ranging from 0 (Not at all) to 10 (Extremely) with higher scores reflecting increased impairment. The SDS will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in functional impairment.	Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up