PTSDNCT04765319
Delivery Considerations of Cognitive Processing Therapy for PTSD
An observational study of PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial summary
Review treatment outcomes of modifications to standard delivery of CPT for PTSD that are delivered as routine care at in VA outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- CPT for PTSD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 24 Mar 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans seeking treatment for PTSD at VA outpatient specialty clinic.
Who may be able to join
- PTSD diagnosis
- Veterans eligible for VA care
- Treatment seeking Veterans
Who cannot join
- PTSD not priority of treatment due to comorbidity, safety, etc. All patients that would be treated for PTSD in outpatient clinic are included.
Trial locations and contacts
1 site in 1 country.
About this study
Review treatment outcomes of modifications to standard delivery of CPT for PTSD that are delivered as routine care at in VA outpatient clinic.
Read the detailed description
Background and Introduction Cognitive Processing Therapy (CPT) is an evidenced based psychotherapy for PTSD. It is considered a first line treatment and has ample evidence supporting it's effectiveness (ISTSS and VA/DOD clinical practice guidelines). This therapy is manualized and a framework is provided to ensure consistent delivery. Additionally, the VA Office of Mental Health Operations sponsors training and dissemination of CPT throughout the VA system and the PI of this study is a trainer and consultant of this therapy. Flexibility exists in the protocol and CPT can be delivered in unorthodox modalities such as telehealth (Moreland et al, 2015) and on compressed time schedules (Held et al, 2020; Bryan et al, 2018). While the literature supports the effectiveness of these interventions in unique settings, no known studies have looked at outcome data of real-world outpatient clinics. The PTSD Clinical Team provides CPT as part of it's standard care with a variety of adaptations. The team practices measurement based care and routinely collects self-report symptom inventories to track patient progress. This study aims to use data collected as part of standard care in this clinic to evaluate the effectiveness of these treatment adaptations in this setting.
Purpose and Objectives The purpose of this study is to explore the impact of how CPT for PTSD is delivered. Initial areas of review will include in person vs. telehealth delivery and timing (daily vs. weekly).
- Conditions
- PTSD
- Being tested
- CPT for PTSD
- 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.
CPT for PTSDBehavioural
Evidence based psychotherapy for PTSD
| Study group | Role | What they receive |
|---|---|---|
| Vets | Veterans receiving care from the PTSD Clinical Team at the Salt Lake City VAMC. All participants are adults with a diagnosis of PTSD. This study plans on reviewing data collected as part of standard clinical practices. The study will have no impact on the treatment provided to the patient. Receives: Behavioral: CPT for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist 5
Self report PTSD symptom inventory
Measured: Through study completion, an average of 12 sessions (3 months)
Secondary outcomes (1)
PHQ-9
Self report depression symptom inventory
Measured: Through study completion, an average of 12 sessions (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2016
- Primary completion1 Aug 2020
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Harrison R Weinstein, VA Salt Lake City Health Care System
- Investigators
- Harrison R Weinstein, PhD, Principal investigator, VA Salt Lake City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765319
- Sponsor's protocol ID
- IRB_00133139
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not included in current IRB.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Considerations of Cognitive Processing Therapy for PTSD
- ClinicalTrials.gov ID
- NCT04765319
- Acronym / sponsor ID
- IRB_00133139
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 21 Feb 2021 (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.
Review treatment outcomes of modifications to standard delivery of CPT for PTSD that are delivered as routine care at in VA outpatient clinic.
Detailed description
Background and Introduction Cognitive Processing Therapy (CPT) is an evidenced based psychotherapy for PTSD. It is considered a first line treatment and has ample evidence supporting it's effectiveness (ISTSS and VA/DOD clinical practice guidelines). This therapy is manualized and a framework is provided to ensure consistent delivery. Additionally, the VA Office of Mental Health Operations sponsors training and dissemination of CPT throughout the VA system and the PI of this study is a trainer and consultant of this therapy. Flexibility exists in the protocol and CPT can be delivered in unorthodox modalities such as telehealth (Moreland et al, 2015) and on compressed time schedules (Held et al, 2020; Bryan et al, 2018). While the literature supports the effectiveness of these interventions in unique settings, no known studies have looked at outcome data of real-world outpatient clinics. The PTSD Clinical Team provides CPT as part of it's standard care with a variety of adaptations. The team practices measurement based care and routinely collects self-report symptom inventories to track patient progress. This study aims to use data collected as part of standard care in this clinic to evaluate the effectiveness of these treatment adaptations in this setting.
Purpose and Objectives The purpose of this study is to explore the impact of how CPT for PTSD is delivered. Initial areas of review will include in person vs. telehealth delivery and timing (daily vs. weekly).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vets | – | Behavioral: CPT for PTSDVeterans receiving care from the PTSD Clinical Team at the Salt Lake City VAMC. All participants are adults with a diagnosis of PTSD. This study plans on reviewing data collected as part of standard clinical practices. The study will have no impact on the treatment provided to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans seeking treatment for PTSD at VA outpatient specialty clinic.
Key inclusion criteria (3 listed)
- PTSD diagnosis
- Veterans eligible for VA care
- Treatment seeking Veterans
Key exclusion criteria (1 listed)
- PTSD not priority of treatment due to comorbidity, safety, etc. All patients that would be treated for PTSD in outpatient clinic are included.
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 |
|---|---|---|
| CPT for PTSDEvidence based psychotherapy for PTSD | Behavioural | Vets |
Primary outcome
PTSD Checklist 5
Time frame: Through study completion, an average of 12 sessions (3 months)
Self report PTSD symptom inventory
1 secondary outcome
PHQ-9
Time frame: Through study completion, an average of 12 sessions (3 months)
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 28 Mar 2025.
- Individual participant dataSharing planned: No. Not included in current IRB.
Related trials for PTSD
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
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.
Harrison R Weinstein, PhD principal investigator
VA Salt Lake City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by VA Salt Lake City Health Care System 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 3 inclusion and 1 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 28 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?
PTSD Checklist 5 (time frame: Through study completion, an average of 12 sessions (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.