Suicide and Trauma Reduction Initiative Among VEterans

NCT ID: NCT03933059

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R&R Park City, Utah

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.

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type 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.

R&R Salt Lake City, Utah

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.

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type 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.

Weekly Treatment 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.

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type 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.

Interventions

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Psychotherapy

Cognitive Processing Therapy is a primarily cognitive form of Cognitive Behavioral Therapy, which has been shown to be effective at reducing symptoms of PTSD.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Boeing Company

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29917224 (View on PubMed)

Other Identifiers

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300841

Identifier Type: -

Identifier Source: org_study_id

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