Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Disorders, Post-Traumatic
- Sponsor
- VA Office of Research and Development
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Baseline and one-month follow-up
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.
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Baseline, post-intervention (10-weeks), and one-month follow-up
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.
Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)
Time Frame: Baseline, post-intervention (10-weeks), and one-month follow-up
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.
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: Post-intervention (10-weeks)
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.
Secondary Outcomes
- 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)