PTSD - Post Traumatic Stress DisorderNCT06733376
Evaluating Evidenced Based Options for PTSD Treatment
A study testing Cognitive Processing Therapy, Prolonged Exposure and Skills Training for Affective and Interpersonal Regulation in people with PTSD - Post Traumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study will look at: How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment. The goal is to improve personalized care by: Identifying factors that might predict how someone will respond to a second treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy, Prolonged Exposure and Skills Training for Affective and Interpersonal Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 1 Jun 2030
- 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
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
- Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study
Who cannot join
- The index traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., current plan and imminent intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment
- They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)
- They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment
Show all 11Show fewer
- They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- They have an active substance use disorder (within the past three months) that would require immediate medical observation if substance was abruptly discontinued
- They are involved with current legal actions related to their index trauma
- They have a visual or auditory impairment that would prevent them from fully participating in study activities
- They, at the time of consent, appear to have extenuating life circumstances (i.e., unstable housing, no internet access, etc.) which, in the judgement of the study team, could affect the ability to deliver interventions with fidelity
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, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Held, 312-942-1442, philip_held@rush.edu
Pridgen, sarah_pridgen@rush.edu
About this study
Official title: Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
This study will look at:
How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.
The goal is to improve personalized care by:
Identifying factors that might predict how someone will respond to a second treatment.
Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.
The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy, Prolonged Exposure, Skills Training for Affective and Interpersonal Regulation
- Keywords
- ptsd treatment
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT
Cognitive Processing Therapy is a first-line intervention for the treatment of PTSD that focuses on changing unhelpful patterns of thinking.
Prolonged ExposureBehavioural
Also called PE
Prolonged Exposure is an evidence-based treatment for PTSD that helps to reduce the intensity of distress by gradually exposing participants to trauma-related memories, feelings, and situations in real life.
Skills Training for Affective and Interpersonal RegulationBehavioural
Also called STAIR
Skills Training for Affective and Interpersonal Regulation (STAIR) is a evidence-based treatment geared towards helping regulate emotional and interpersonal needs of those with PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Initial Course of Cognitive Processing Therapy | Other | All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy. Receives: Behavioral: Cognitive Processing Therapy |
| Subsequent Treatment | Active comparator | At one-week follow up after initial Cognitive Processing Therapy, participants whose scores are 28 or above on the PTSD Checklist for DSM-5 will be offered a subsequent course of treatment. Receives: Behavioral: Cognitive Processing Therapy; Behavioral: Prolonged Exposure; Behavioral: Skills Training for Affective and Interpersonal Regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
A self-report measure of PTSD symptom severity
Measured: Baseline to 6 month follow up
Clinician Administered PTSD Scale for DSM-5
A clinician-rated assessment of PTSD
Measured: Baseline to 6 mont follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start6 Oct 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
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 PTSD - Post Traumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Held, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733376
- Sponsor's protocol ID
- 23091403
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2024
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Held P, Hutzler I, Warren M, Streubel O, Pridgen SA, Smith DL, Cloitre M, Rothbaum BO, Kaysen DL. Evaluating evidence based options for initial PTSD treatment non-response: A randomized controlled trial protocol. Contemp Clin Trials Commun. 2026 Sep 15;54:101685. doi: 10.1016/j.conctc.2026.101685. eCollection 2026 Dec.
PubMed 42780432
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
- ClinicalTrials.gov ID
- NCT06733376
- Acronym / sponsor ID
- 23091403
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- ptsd treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 13 Dec 2024 (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.
This study will look at:
How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.
The goal is to improve personalized care by:
Identifying factors that might predict how someone will respond to a second treatment.
Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.
The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Course of Cognitive Processing Therapy | Other | Behavioral: Cognitive Processing TherapyAll participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy. |
| Subsequent Treatment | Active comparator | Behavioral: Cognitive Processing Therapy, Behavioral: Prolonged Exposure, Behavioral: Skills Training for Affective and Interpersonal RegulationAt one-week follow up after initial Cognitive Processing Therapy, participants whose scores are 28 or above on the PTSD Checklist for DSM-5 will be offered a subsequent course of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
- Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)
Key exclusion criteria (11 listed)
- The index traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., current plan and imminent intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment
- They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)
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 |
|---|---|---|
| Cognitive Processing TherapyAlso: CPTCognitive Processing Therapy is a first-line intervention for the treatment of PTSD that focuses on changing unhelpful patterns of thinking. | Behavioural | Initial Course of Cognitive Processing Therapy, Subsequent Treatment |
| Prolonged ExposureAlso: PEProlonged Exposure is an evidence-based treatment for PTSD that helps to reduce the intensity of distress by gradually exposing participants to trauma-related memories, feelings, and situations in real life. | Behavioural | Subsequent Treatment |
| Skills Training for Affective and Interpersonal RegulationAlso: STAIRSkills Training for Affective and Interpersonal Regulation (STAIR) is a evidence-based treatment geared towards helping regulate emotional and interpersonal needs of those with PTSD. | Behavioural | Subsequent Treatment |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to 6 month follow up
A self-report measure of PTSD symptom severity
Clinician Administered PTSD Scale for DSM-5
Time frame: Baseline to 6 mont follow up
A clinician-rated assessment of PTSD
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 22 Oct 2025.
- Derived from this study: PubMed 42780432Held P, Hutzler I, Warren M, Streubel O, Pridgen SA, Smith DL, Cloitre M, Rothbaum BO, Kaysen DL. Evaluating evidence based options for initial PTSD treatment non-response: A randomized controlled trial protocol. Contemp Clin Trials Commun. 2026 Sep 15;54:101685. doi: 10.1016/j.conctc.2026.101685. eCollection 2026 Dec.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy, Prolonged Exposure and Skills Training for Affective and Interpersonal Regulation in people with PTSD - Post Traumatic Stress Disorder, run by Rush University Medical Center 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Oct 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?
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 Philip Held, PhD (312-942-1423, philip_held@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline to 6 month follow up). 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 NCT06733376, 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 22 Oct 2025.