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Completed

NCT Number: NCT03933059

Suicide and Trauma Reduction Initiative Among VEterans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psychotherapy

Other

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 outcomes

  1. Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale

    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

    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.

  2. Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale

    Time frame: Past week symptoms, assessed the last day of treatment for those completing the two week treatment retreats

    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 outcomes

  1. Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation

    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

    Self-report assessment of severity of suicidal thoughts and behaviors. Items are summed (range: 0-63) and higher scores indicate greater suicide severity.

  2. Change in depression symptom severity since baseline measured by the Patient Health Questionnaire

    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

    Self-report assessment of depression symptom severity. Items are summed (range: 0-27) and higher scores indicate greater depression symptom severity.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • The Boeing Company

Registry information

Acronym: STRIVE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 1, 2019
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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