Stress Disorders, Post-TraumaticSTRIVENCT03933059
Suicide and Trauma Reduction Initiative Among VEterans
A study testing Psychotherapy in people with Stress Disorders, Post-Traumatic, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Cognitive Processing Therapy is a primarily cognitive form of Cognitive Behavioral Therapy, which has been shown to be effective at reducing symptoms of PTSD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Self-report assessment of severity of suicidal thoughts and behaviors. Items are summed (range: 0-63) and higher scores indicate greater suicide severity.
Measured: 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
Self-report assessment of depression symptom severity. Items are summed (range: 0-27) and higher scores indicate greater depression symptom severity.
Measured: Past two week symptoms, assessed within a month of completing treatment, and 6-months, 12-months, 18-months, and 24 months after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start21 Mar 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- The Boeing Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933059
- Sponsor's protocol ID
- 300841
- Acronym
- STRIVE
- Status last verified
- May 2023
- First submitted
- 18 Apr 2019
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29917224
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide and Trauma Reduction Initiative Among VEterans
- ClinicalTrials.gov ID
- NCT03933059
- Acronym / sponsor ID
- STRIVE / 300841
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- The Boeing Company
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R&R Park City, Utah | Active comparator | Other: PsychotherapyThis 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. |
| R&R Salt Lake City, Utah | Active comparator | Other: PsychotherapyThis 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. |
| Weekly Treatment Salt Lake City, Utah | Active comparator | Other: PsychotherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyCognitive Processing Therapy is a primarily cognitive form of Cognitive Behavioral Therapy, which has been shown to be effective at reducing symptoms of PTSD. | Other | R&R Park City, Utah, R&R Salt Lake City, Utah, Weekly Treatment Salt Lake City, Utah |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 29917224Bryan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Stress Disorders, Post-Traumatic, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.