PTSDNCT05165940
Facilitating Transition to Recommended PTSD Treatment
A study testing Treatment As Usual and New Health Services Intervention in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Treatment As Usual and New Health Services Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 3 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Veteran
- Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center
Who cannot join
- Inability to provide informed consent
- Cognitive impairment that precludes comprehension of study materials
- Active psychosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
Nicholas Holder, PhD, (415) 221-4810 ext. 23084, nicholas.holder@va.gov
Nicholas Holder, PhD
About this study
Official title: Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)
Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.
Read the detailed description
Posttraumatic stress disorder (PTSD) is one of the most common mental health diagnoses among Veterans. Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated in the Veterans Health Administration (VHA) as recommended PTSD treatments. Despite these efforts, few post-9/11 Veterans diagnosed with PTSD initiate CPT or PE. In the small percentage of Veterans who receive these therapies, CPT and PE are rarely the first treatment a Veteran receives. A common treatment sequence identified in implementation research, begins with "stabilization treatment," combinations of psychosocial and medication treatments that prepare Veterans for CPT or PE. Despite consistently identifying stabilization treatment as a common VHA practice, little research has investigated this treatment sequence. A novel approach to solving existing limitations in PTSD treatment delivery involves developing an intervention that both acknowledges the ubiquitous presence and benefits of stabilization treatment, while facilitating timely transition from stabilization treatment to CPT or PE. This CDA-2 aims to improve delivery of PTSD services in the VHA. The proposed research aims are: (1) To qualitatively understand Veterans' and clinicians' perspectives on selecting stabilization treatments and how stabilization treatment serves as a barrier or facilitator of transition to CPT or PE; (2) To develop and conduct a randomized, pragmatic pilot trial of a brief, Veteran-centered intervention to support transition from stabilization treatment to CPT or PE; and (3) To identify sociodemographic disparities in treatment sequences and to determine how treatment sequences influence time to CPT or PE initiation across the VHA.
- Conditions
- PTSD
- Being tested
- Treatment As Usual, New Health Services Intervention
- Keywords
- 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.
Treatment As UsualBehavioural
Care Coordination Treatment as usual with a VA mental health treatment coordinator
New Health Services InterventionBehavioural
The experimental care coordination intervention begins with a 60-minute in-person session and continues with regular, brief contacts between the Veteran and clinician. During the first session, the clinician and Veteran will (1) discuss the Veteran's beliefs about their presenting problem; (2) collaboratively identify SMART goals; (3) discuss treatment options; (4) use shared decision-making to match treatment to SMART goals; (5) develop criteria to evaluate treatment progress; and (6) manage treatment expectations. During follow-up sessions, the clinician and Veteran will reflect on treatment progress, make appropriate updates to SMART goals, and re-evaluate barriers to CPT or PE.
| Study group | Role | What they receive |
|---|---|---|
| TAU | Active comparator | Treatment As Usual with a VA mental health treatment coordinator Receives: Behavioral: Treatment As Usual |
| New Health Services Intervention | Experimental | Novel health services intervention with a VA mental health treatment coordinator Receives: Behavioral: New Health Services Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Recommended PTSD Treatment
Patient self-report or documentation in the electronic health record of initiating either cognitive processing therapy (CPT) or prolonged exposure therapy (PE).
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)
Patient self-report or documentation in the electronic health record that a patient has discontinued all mental health treatment without provider concurrence.
Measured: Through study completion, an average of 1 year
Limited Efficacy Testing (PTSD Symptom Severity)
Self-Reported PTSD Symptom Severity as assessed by the PTSD Checklist for DSM-5.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Dec 2026 (estimated)
- Primary completion3 May 2027 (estimated)
- Study completion3 May 2027 (estimated)
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.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive care coordination as usual (i.e., TAU) through the VA or an experimental care coordination intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- White River Junction Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Nicholas Holder, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165940
- Sponsor's protocol ID
- CDX 22-002
- Other IDs
- 1IK2HX003339-01A2
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)
- ClinicalTrials.gov ID
- NCT05165940
- Acronym / sponsor ID
- CDX 22-002
- Conditions
- PTSD
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- White River Junction Veterans Affairs Medical Center
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 21 Dec 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.
Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.
Detailed description
Posttraumatic stress disorder (PTSD) is one of the most common mental health diagnoses among Veterans. Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated in the Veterans Health Administration (VHA) as recommended PTSD treatments. Despite these efforts, few post-9/11 Veterans diagnosed with PTSD initiate CPT or PE. In the small percentage of Veterans who receive these therapies, CPT and PE are rarely the first treatment a Veteran receives. A common treatment sequence identified in implementation research, begins with "stabilization treatment," combinations of psychosocial and medication treatments that prepare Veterans for CPT or PE. Despite consistently identifying stabilization treatment as a common VHA practice, little research has investigated this treatment sequence. A novel approach to solving existing limitations in PTSD treatment delivery involves developing an intervention that both acknowledges the ubiquitous presence and benefits of stabilization treatment, while facilitating timely transition from stabilization treatment to CPT or PE. This CDA-2 aims to improve delivery of PTSD services in the VHA. The proposed research aims are: (1) To qualitatively understand Veterans' and clinicians' perspectives on selecting stabilization treatments and how stabilization treatment serves as a barrier or facilitator of transition to CPT or PE; (2) To develop and conduct a randomized, pragmatic pilot trial of a brief, Veteran-centered intervention to support transition from stabilization treatment to CPT or PE; and (3) To identify sociodemographic disparities in treatment sequences and to determine how treatment sequences influence time to CPT or PE initiation across the VHA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive care coordination as usual (i.e., TAU) through the VA or an experimental care coordination intervention.
| Arm | Type | Receives |
|---|---|---|
| TAU | Active comparator | Behavioral: Treatment As UsualTreatment As Usual with a VA mental health treatment coordinator |
| New Health Services Intervention | Experimental | Behavioral: New Health Services InterventionNovel health services intervention with a VA mental health treatment coordinator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran
- Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Cognitive impairment that precludes comprehension of study materials
- Active psychosis
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 |
|---|---|---|
| Treatment As UsualCare Coordination Treatment as usual with a VA mental health treatment coordinator | Behavioural | TAU |
| New Health Services InterventionThe experimental care coordination intervention begins with a 60-minute in-person session and continues with regular, brief contacts between the Veteran and clinician. During the first session, the clinician and Veteran will (1) discuss the Veteran's beliefs about their presenting problem; (2) collaboratively identify SMART goals; (3) discuss treatment options; (4) use shared decision-making to match treatment to SMART goals; (5) develop criteria to evaluate treatment progress; and (6) manage treatment expectations. During follow-up sessions, the clinician and Veteran will reflect on treatment progress, make appropriate updates to SMART goals, and re-evaluate barriers to CPT or PE. | Behavioural | New Health Services Intervention |
Primary outcome
Initiation of Recommended PTSD Treatment
Time frame: Through study completion, an average of 1 year
Patient self-report or documentation in the electronic health record of initiating either cognitive processing therapy (CPT) or prolonged exposure therapy (PE).
2 secondary outcomes
Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)
Time frame: Through study completion, an average of 1 year
Limited Efficacy Testing (PTSD Symptom Severity)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Nicholas Holder, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual and New Health Services Intervention in people with PTSD, run by VA Office of Research and Development 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Holder, PhD ((415) 221-4810 ext. 23084, nicholas.holder@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of Recommended PTSD Treatment (time frame: Through study completion, an average of 1 year). 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 18 Aug 2026.