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

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ClinicalTrials.gov Identifier: NCT04515784
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 3, 2020
First Posted Date  ICMJE August 17, 2020
Last Update Posted Date August 17, 2020
Estimated Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • 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 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Aid Reduction Treatment for PTSD Among Veterans
Official Title  ICMJE Examination of a Safety Aid Reduction Protocol for Treatment Resistant PTSD Among Veterans
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 allocation ratio
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessments will be conducted by a member of the study team who is blind to veteran treatment condition.
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Active
    Active arm- START-PTSD
    Intervention: Behavioral: Safety Aid Reduction Treatment for PTSD
  • No Intervention: Control
    Control arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2020)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 29, 2024
Estimated Primary Completion Date February 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amanda M Raines, PhD (504) 507-2000 ext 67372 amanda.raines@va.gov
Contact: Jessica L Chambliss, MS (504) 507-2000 ext 65195 jessica.chambliss@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04515784
Other Study ID Numbers  ICMJE MHBP-003-19F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 request 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.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amanda Medley Raines, PhD Southeast Louisiana Veterans Health Care System, New Orleans, LA
PRS Account VA Office of Research and Development
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP