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Suicide and Trauma Reduction Initiative Among VEterans (STRIVE)

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older;
  2. Current or prior service in the U.S. military;
  3. Currently meet criteria for a diagnosis of posttraumatic stress disorder (as determined by the CAPS-5);
  4. Be able to complete the informed consent process.

Exclusion Criteria:

  1. Current substance dependence disorder;
  2. Severe suicide ideation during the past two weeks (as determined by the BSSI and clinical interview) warranting hospitalization;
  3. Suicide attempt during the previous three months;
  4. Impaired mental status that precludes ability to provide informed consent (e.g., intoxication, psychosis, mania).

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

R&R Park City, Utah

R&R Salt Lake City, Utah

Weekly Treatment Salt Lake City, Utah

Arm Description

This group will receive 12 daily individual sessions of CPT at the National Ability Center in Park City, Utah. They will also participate in daily recreational activities.

This group will receive 12 daily individual sessions of CPT at the National Center for Veterans Studies located on the University of Utah campus in Salt Lake City, Utah.

This group will receive 12 individual sessions of CPT on a weekly basis at the National Center for Veterans Studies located on the University of Utah campus in Salt Lake City, Utah.

Outcomes

Primary Outcome Measures

Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
Interviewer administered measure to determine the severity of PTSD. Items are summed to create a total score (Range: 0-80) where higher scores indicate greater symptom severity.
Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
Interviewer administered measure to determine the severity of PTSD. Items are summed to create a total score (Range: 0-80) where higher scores indicate greater symptom severity.

Secondary Outcome Measures

Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
Self-report assessment of severity of suicidal thoughts and behaviors. Items are summed (range: 0-63) and higher scores indicate greater suicide severity.
Change in depression symptom severity since baseline measured by the Patient Health Questionnaire
Self-report assessment of depression symptom severity. Items are summed (range: 0-27) and higher scores indicate greater depression symptom severity.

Full Information

First Posted
April 18, 2019
Last Updated
May 15, 2023
Sponsor
University of Utah
Collaborators
The Boeing Company
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1. Study Identification

Unique Protocol Identification Number
NCT03933059
Brief Title
Suicide and Trauma Reduction Initiative Among VEterans
Acronym
STRIVE
Official Title
Suicide and Trauma Reduction Initiative Among VEterans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
The Boeing Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study is a pragmatic clinical trial that will examine the effectiveness of Cognitive Processing Therapy (CPT) in reducing PTSD symptom severity, depression symptoms, and suicidal thoughts among military personnel and veterans with PTSD when delivered in three different formats: (1)12 sessions delivered once per week in an office/clinic setting; (2) 12 sessions delivered once per day in an office/clinic setting; and (3) 12 sessions delivered once per day in a recreational setting.
Detailed Description
Cognitive behavioral treatments tend to be the most highly efficacious treatments for posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was among the most effective treatments for PTSD (Watts et al., 2013). Despite its efficacy, many military personnel and veterans with PTSD will not receive CPT (or other recommended treatments) for a variety of reasons. It is possible that adapting CPT from its traditional weekly or biweekly format might both enhance the provision of CPT and reduce barriers to treatment. Specifically, treatment that is compressed into a relatively shorter window may be easier for service members and veterans to complete. In light of these possibilities, the National Center for Veterans Studies (NCVS) at The University of Utah created the R&R program, an intensive, two-week treatment program for service members and veterans diagnosed with PTSD in partnership with the National Ability Center (NAC), a nonprofit recreational and adaptive sports center located in Park City, Utah. The R&R Program provides CPT in a format designed to circumvent logistical barriers to care and to maximize treatment completion. Preliminary results from 20 service members or veterans who have completed the program show that approximately 70% no longer met criteria for PTSD after completing the program, and suicide ideation decreased significantly (Bryan et al., 2018). Treatment gains during R&R were superior to those found in CPT randomized trials. The present study seeks to build and broaden current research on CPT. First, it will directly compare the effectiveness of traditional 12-session weekly outpatient CPT against intensive, daily delivery of CPT over 12 days. Second, it will test whether the use of recreational activities improves intensive care by comparing intensive treatment at the NAC with recreational activities against intensive treatment in Salt Lake City without recreational activities. Finally, it will provide important data on the long-term effects of treatment, by assessing PTSD, depression, and suicidal thoughts and behaviors at posttreatment, and 6, 12, and 24 months posttreatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R&R Park City, Utah
Arm Type
Active Comparator
Arm Description
This group will receive 12 daily individual sessions of CPT at the National Ability Center in Park City, Utah. They will also participate in daily recreational activities.
Arm Title
R&R Salt Lake City, Utah
Arm Type
Active Comparator
Arm Description
This group will receive 12 daily individual sessions of CPT at the National Center for Veterans Studies located on the University of Utah campus in Salt Lake City, Utah.
Arm Title
Weekly Treatment Salt Lake City, Utah
Arm Type
Active Comparator
Arm Description
This group will receive 12 individual sessions of CPT on a weekly basis at the National Center for Veterans Studies located on the University of Utah campus in Salt Lake City, Utah.
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
Cognitive Processing Therapy is a primarily cognitive form of Cognitive Behavioral Therapy, which has been shown to be effective at reducing symptoms of PTSD.
Primary Outcome Measure Information:
Title
Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
Description
Interviewer administered measure to determine the severity of PTSD. Items are summed to create a total score (Range: 0-80) where higher scores indicate greater symptom severity.
Time Frame
Past month symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
Title
Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
Description
Interviewer administered measure to determine the severity of PTSD. Items are summed to create a total score (Range: 0-80) where higher scores indicate greater symptom severity.
Time Frame
Past week symptoms, assessed the last day of treatment for those completing the two week treatment retreats
Secondary Outcome Measure Information:
Title
Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
Description
Self-report assessment of severity of suicidal thoughts and behaviors. Items are summed (range: 0-63) and higher scores indicate greater suicide severity.
Time Frame
Past week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
Title
Change in depression symptom severity since baseline measured by the Patient Health Questionnaire
Description
Self-report assessment of depression symptom severity. Items are summed (range: 0-27) and higher scores indicate greater depression symptom severity.
Time Frame
Past two week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older; Current or prior service in the U.S. military; Currently meet criteria for a diagnosis of posttraumatic stress disorder (as determined by the CAPS-5); Be able to complete the informed consent process. Exclusion Criteria: Current substance dependence disorder; Severe suicide ideation during the past two weeks (as determined by the BSSI and clinical interview) warranting hospitalization; Suicide attempt during the previous three months; Impaired mental status that precludes ability to provide informed consent (e.g., intoxication, psychosis, mania).
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29917224
Citation
Bryan CJ, Leifker FR, Rozek DC, Bryan AO, Reynolds ML, Oakey DN, Roberge E. Examining the effectiveness of an intensive, 2-week treatment program for military personnel and veterans with PTSD: Results of a pilot, open-label, prospective cohort trial. J Clin Psychol. 2018 Dec;74(12):2070-2081. doi: 10.1002/jclp.22651. Epub 2018 Jun 19.
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Suicide and Trauma Reduction Initiative Among VEterans

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