Clinical trial NCT03933059: Suicide and Trauma Reduction Initiative Among VEterans
Official title: Suicide and Trauma Reduction Initiative Among VEterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: The Boeing Company
First posted: 2019-05-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
timeFrame: Past month symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
measure: Change in PTSD symptom severity since baseline measured by the Clinician Administered PTSD Scale
timeFrame: Past week symptoms, assessed the last day of treatment for those completing the two week treatment retreats
Secondary outcomes:
measure: Change in suicidal thoughts and behaviors since baseline measured by the Scale for Suicidal Ideation
timeFrame: Past week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
measure: Change in depression symptom severity since baseline measured by the Patient Health Questionnaire
timeFrame: Past two week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
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.