Clinical trial NCT04515784: Safety Aid Reduction Treatment for PTSD Among Veterans
Official title: Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Safety aid
Treatment
Posttraumatic Stress Disorder
Veteran
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-arm trial
Primary purpose: TREATMENT

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.

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 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.

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

Primary outcomes:
measure: Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline and one-month follow-up
measure: Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
measure: Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-intervention (10-weeks)
Secondary outcomes:
measure: Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
measure: Changes in depression as measured by the Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
measure: Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
measure: Changes in funtional impairment as measured by the Sheehan Disability Scale (SDS)
timeFrame: Baseline, post-intervention (10-weeks), and one-month follow-up
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System, New Orleans, LA
state: Louisiana
Study officials:
affiliation: Southeast Louisiana Veterans Health Care System, New Orleans, LA
name: Amanda M Raines, PhD
role: PRINCIPAL_INVESTIGATOR
References: