Safety Aid Reduction Treatment for PTSD Among Veterans

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Safety Aid Reduction Treatment for PTSD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 allocation ratio
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Active arm- START-PTSD | Behavioral: Safety Aid Reduction Treatment for PTSD<br>* 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).<br>|
| No Intervention: Control<br>Control arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety aid, Treatment, Posttraumatic Stress Disorder, Veteran