Safety Aid Reduction Treatment for PTSD Among Veterans (START-PTSD)

October 4, 2023 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Southeast Louisiana Veterans Health Care System, New Orleans, LA
        • Contact:
        • Principal Investigator:
          • Amanda M Raines, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Active arm- START-PTSD
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).
No Intervention: Control
Control arm

What is the study measuring?

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)
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.
Baseline and one-month follow-up
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Baseline, post-intervention or wait-list (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 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)
Time Frame: Baseline, post-intervention or wait-list (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 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)
Time Frame: Post-intervention or wait-list (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 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)
Time Frame: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
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)
Time Frame: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
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)
Time Frame: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
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)
Time Frame: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Amanda M Raines, PhD, Southeast Louisiana Veterans Health Care System, New Orleans, LA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBP-003-19F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to disclose data outside of the VA, however, if there is a need to disclose data outside of the VA (e.g., a member of the scientific community requests a copy), IRB approval will be sought, data will be de-identified prior to disclosing, and the disclosure will be recorded on a VA disclosure log as required by VA policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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