Suicide and Trauma Reduction Initiative Among VEterans

NCT03933059 | Completed

• 1 other identifier: 300841
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• 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.

  Past month symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment

• 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.

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

Secondary Outcomes (2)

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

  Past week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment

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

  Past two week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment

Study Arms (3)

R&R Park City, Utah

ACTIVE COMPARATOR

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.

Other: Psychotherapy

R&R Salt Lake City, Utah

ACTIVE COMPARATOR

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.

Other: Psychotherapy

Weekly Treatment Salt Lake City, Utah

ACTIVE COMPARATOR

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.

Other: Psychotherapy

Interventions

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.

R&R Park City, Utah; R&R Salt Lake City, Utah; Weekly Treatment Salt Lake City, Utah

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Utah: lead
• The Boeing Company: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 29917224 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 1, 2019
• Study Start: March 21, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 4, 2025

Record last verified: 2023-05

Locations

US (1)