Posttraumatic Stress DisorderADAPT-PTSDNCT07176273
Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)
A study testing Modular Cognitive Processing Therapy, Modular Prolonged Exposure Therapy and Step Down Treatment in people with Posttraumatic Stress Disorder and PTSD, run by The University of Texas Health Science Center at San Antonio at 4 sites in United States.
Trial summary
By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, PTSD
- What is being tested?
- Modular Cognitive Processing Therapy, Modular Prolonged Exposure Therapy and Step Down Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Dec 2025to 14 Aug 2028
- 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
- Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
- At least 18 years or older
- Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
- Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).
Who cannot join
- Acute suicide risk requiring clinical intervention
- Need for detoxification
- Unmanaged psychosis or bipolar disorder
- Severe cognitive impairment that makes it unlikely that participants can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- Current or past 12-month engagement in PE or CPT.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Ann Arbor VA
Ann Arbor, Michigan, 48105
Rebecca Sripada, PhD, 734-222-7432, vhaannadapt@va.gov
- Recruiting
Augusta VA
Augusta, Georgia, 30904
J. Richard Monroe, 734-222-7432, vhaannadapt@va.gov
- Not yet recruiting
Battle Creek VA
Battle Creek, Michigan, 49037
Rebecca Sripada, PhD, 734-222-7432, vhaannadapt@va.gov
- Recruiting
Salt Lake City VA
Salt Lake City, Utah, 84148
Erika Roberge, 734-222-7432, vhaannadapt@va.gov
About this study
Official title: Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD
By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:
- See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
- See if sending text message prompts between sessions encourages more completion of between-session homework
Read the detailed description
This study is designed to assist the investigators in answering the clinical question of how to address non-response to first line PTSD treatments. Utilizing an innovative Hybrid Experimental Design (HED), the proposed study involves multiple, sequential randomizations to both therapist-delivered and digital interventions operating on short and long timescales to determine the optimal combination and sequencing of evidence-based interventions to maximize response. This will result in actionable data and, consistent with a personalized medicine approach, an implementable, adaptive treatment regimen that optimizes clinical resource allocation. By recruiting and providing treatment in routine care settings serving veterans with PTSD, the study design maximizes generalizability, relevance to the VA mission, and implementation potential.
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Being tested
- Modular Cognitive Processing Therapy, Modular Prolonged Exposure Therapy, Step Down Treatment, Digital Interventions, Cognitive Processing Therapy (CPT)
- Keywords
- Veterans
- 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.
Modular Cognitive Processing TherapyBehavioural
Also called Modular CPT
CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of Contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need. Modular CPT contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need.
Modular Prolonged Exposure TherapyBehavioural
Also called Modular PE
PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. Modular PE is comprised of the same elements of standard PE, but clinicians select and dose modules (i.e., imaginal exposure, in vivo exposure) based on individual patient need.
Step Down TreatmentBehavioural
Also called Step Down
Self-managed treatment will involve receiving a self-help version of the remaining treatment materials and ongoing use of the intervention companion app (CPT Coach or PE Coach).
Digital InterventionsBehavioural
Also called Daily Digital Prompts
The prompt will be a text message delivered through VA-approved technology (e.g., PETALS).
Cognitive Processing Therapy (CPT)Behavioural
Also called CPT
CPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of progressive worksheets to examine stuck points, develop balanced beliefs, and facilitate the experience of natural emotions.
Prolonged Exposure (PE)Behavioural
Also called PE
PE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. In imaginal exposure, participants repeatedly, systematically approach their trauma memory and related thoughts and feelings. In in vivo exposure, participants repeatedly, systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma.
| Study group | Role | What they receive |
|---|---|---|
| Early CPT Non-Responders Switch (Group A) | Active comparator | Early NON-RESPONDERS to CPT will SWITCH to PE Receives: Behavioral: Digital Interventions; Behavioral: Cognitive Processing Therapy (CPT); Behavioral: Prolonged Exposure (PE) |
| Early CPT Non-Responders Modular (Group B) | Active comparator | Early NON-RESPONDERS to CPT will transition to MODULAR CPT Receives: Behavioral: Modular Cognitive Processing Therapy; Behavioral: Digital Interventions; Behavioral: Cognitive Processing Therapy (CPT) |
| Early CPT Responders Continue (Group C) | Active comparator | Early RESPONDERS to CPT will CONTINUE in their CPT treatment Receives: Behavioral: Digital Interventions; Behavioral: Cognitive Processing Therapy (CPT) |
| Early CPT Responders Step Down (Group D) | Active comparator | Early RESPONDERS to CPT will STEP DOWN to self-managed CPT Receives: Behavioral: Step Down Treatment; Behavioral: Digital Interventions; Behavioral: Cognitive Processing Therapy (CPT) |
| Early PE Non-Responsers Switch (Group E) | Active comparator | Early NON-RESPONDERS to PE will SWITCH to CPT Receives: Behavioral: Digital Interventions; Behavioral: Cognitive Processing Therapy (CPT); Behavioral: Prolonged Exposure (PE) |
| Early PE Non-Responders Modular (Group F) | Active comparator | Early NON-RESPONDERS to PE will transition to MODULAR PE Receives: Behavioral: Modular Prolonged Exposure Therapy; Behavioral: Digital Interventions; Behavioral: Prolonged Exposure (PE) |
| Early PE Responders Continue (Group G) | Active comparator | Early RESPONDERS will CONTINUE in their PE treatment Receives: Behavioral: Digital Interventions; Behavioral: Prolonged Exposure (PE) |
| Early PE Responders Step Down (Group H) | Active comparator | Early RESPONDERS to PE will STEP DOWN to self-managed PE Receives: Behavioral: Step Down Treatment; Behavioral: Digital Interventions; Behavioral: Prolonged Exposure (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a psychometrically valid measure and commonly used assessment of PTSD symptoms. A total score is calculated by adding up the ratings for each of the 20 items, which range from 0 to 4 (0=Not at all, 4=Extremely). Higher scores reflect more severe symptoms. A score below 31 generally suggests a sub-clinical range, while scores of 31 or above fall within the clinical range, indicating probable PTSD.
Measured: 10 weeks, 20 weeks and 9 months
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 score indicates the severity of depressive symptoms. There are 9 items with scores ranging from 0-3 for each. Total scores range from 0 to 27, with higher scores indicating more severe symptoms. A score of 5-9 is considered mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe. The PHQ-9 score is not a diagnosis, but rather a screening tool to assess depression severity and guide treatment decisions.
Measured: Baseline, 10-weeks, 20-weeks, 9-months
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a standardized measure used to assess suicide risk, primarily through the presence and severity of suicidal ideation and behavior. The screener version of the C-SSRS consists of 2-6 "Yes" or "No" questions. Responses to questions 1 and 2 determine if questions 3, 4, and 5 are asked. A 'Yes' answer to question 2 prompts questions 3, 4, 5, and 6. A 'No' answer to question 2 directs the responder to question 6. Affirmative ("Yes") responses are summed, with each 'Yes' counting as 1 point. This summation provides a score on a scale of 0-6 indicating suicide risk level.
0 = No risk reported (all "No" responses).
1 - 2 = Low risk. 3 - 6 = Moderate to high risk. A "Yes" response to question 3 or 6a indicates moderate risk (potential plan or lifetime engagement in preparatory behavior). A "Yes" response to question 4, 5, or 6b indicates high risk (active plan, possible intent, or recent preparatory behaviors).
Measured: Baseline, 10-weeks, 20-weeks, 9-months
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
The Q-LES-Q-SF contains 16 questions scored on a 5-point Likert scale with values from 1 ("Very Poor") to 5 ("Very Good"). A total score is calculated by summing the first 14 item responses and ranges from 14 to 70; higher scores are associated with greater life satisfaction and enjoyment. The total score is expressed as a percentage based on the maximum total score of the items completed (1-100). The normal range that represents community sample scores is 70-100, and thus scores below 70 are clinically significant. Note, the last two items (items 15 and 16) ask about medication and overall contentment and are stand-alone items; they are not included in the total score.
Measured: Baseline, 20-weeks, 9-months
Brief Inventory of Psychosocial Functioning (B-IPF)
The B-IPF is a 7-item self-report instrument that evaluates PTSD-related psychosocial functional impairment within the last 30 days across seven functional domains (romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care). Items on the B-IPF are scored on a Likert scale from 0 (never) to 6 (always). The B-IPF was designed so that respondents complete only temporally relevant items that reflect a domain that they have participated in over the past 30 days (e.g., participants who were not enrolled in school within the past 30 days are instructed to skip the education item). The BIPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100. Thus, the B-IPF represents an overall index of functioning, with higher scores indicating greater functional impairment
Measured: Baseline, 10-weeks, 20-weeks, 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start12 Dec 2025
- Primary completion22 May 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study is a randomized controlled effectiveness trial utilizing a Hybrid Experimental Design (HED) comprised of a Sequential Multiple Assignment Randomized Trial (SMART) and Micro-Randomized Trial (MRT)
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Stefanie LoSavio, The University of Texas Health Science Center at San Antonio
- Investigators
- Stefanie LoSavio, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioRebecca Sripada, PhD, Principal investigator, VA Ann Arbor-506
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176273
- Sponsor's protocol ID
- STUDY00001551
- Other IDs
- HT9425-24-1-1026
- Acronym
- ADAPT-PTSD
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Treatment Course: Clinical Trial of Sequenced Interventions to Optimize Treatment for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT07176273
- Acronym / sponsor ID
- ADAPT-PTSD / STUDY00001551
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 22 May 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 16 Sep 2025 (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.
By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:
- See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
- See if sending text message prompts between sessions encourages more completion of between-session homework
Detailed description
This study is designed to assist the investigators in answering the clinical question of how to address non-response to first line PTSD treatments. Utilizing an innovative Hybrid Experimental Design (HED), the proposed study involves multiple, sequential randomizations to both therapist-delivered and digital interventions operating on short and long timescales to determine the optimal combination and sequencing of evidence-based interventions to maximize response. This will result in actionable data and, consistent with a personalized medicine approach, an implementable, adaptive treatment regimen that optimizes clinical resource allocation. By recruiting and providing treatment in routine care settings serving veterans with PTSD, the study design maximizes generalizability, relevance to the VA mission, and implementation potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This study is a randomized controlled effectiveness trial utilizing a Hybrid Experimental Design (HED) comprised of a Sequential Multiple Assignment Randomized Trial (SMART) and Micro-Randomized Trial (MRT)
| Arm | Type | Receives |
|---|---|---|
| Early CPT Non-Responders Switch (Group A) | Active comparator | Behavioral: Digital Interventions, Behavioral: Cognitive Processing Therapy (CPT), Behavioral: Prolonged Exposure (PE)Early NON-RESPONDERS to CPT will SWITCH to PE |
| Early CPT Non-Responders Modular (Group B) | Active comparator | Behavioral: Modular Cognitive Processing Therapy, Behavioral: Digital Interventions, Behavioral: Cognitive Processing Therapy (CPT)Early NON-RESPONDERS to CPT will transition to MODULAR CPT |
| Early CPT Responders Continue (Group C) | Active comparator | Behavioral: Digital Interventions, Behavioral: Cognitive Processing Therapy (CPT)Early RESPONDERS to CPT will CONTINUE in their CPT treatment |
| Early CPT Responders Step Down (Group D) | Active comparator | Behavioral: Step Down Treatment, Behavioral: Digital Interventions, Behavioral: Cognitive Processing Therapy (CPT)Early RESPONDERS to CPT will STEP DOWN to self-managed CPT |
| Early PE Non-Responsers Switch (Group E) | Active comparator | Behavioral: Digital Interventions, Behavioral: Cognitive Processing Therapy (CPT), Behavioral: Prolonged Exposure (PE)Early NON-RESPONDERS to PE will SWITCH to CPT |
| Early PE Non-Responders Modular (Group F) | Active comparator | Behavioral: Modular Prolonged Exposure Therapy, Behavioral: Digital Interventions, Behavioral: Prolonged Exposure (PE)Early NON-RESPONDERS to PE will transition to MODULAR PE |
| Early PE Responders Continue (Group G) | Active comparator | Behavioral: Digital Interventions, Behavioral: Prolonged Exposure (PE)Early RESPONDERS will CONTINUE in their PE treatment |
| Early PE Responders Step Down (Group H) | Active comparator | Behavioral: Step Down Treatment, Behavioral: Digital Interventions, Behavioral: Prolonged Exposure (PE)Early RESPONDERS to PE will STEP DOWN to self-managed PE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
- At least 18 years or older
- Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
- Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).
Key exclusion criteria (5 listed)
- Acute suicide risk requiring clinical intervention
- Need for detoxification
- Unmanaged psychosis or bipolar disorder
- Severe cognitive impairment that makes it unlikely that participants can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- Current or past 12-month engagement in PE or CPT.
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 |
|---|---|---|
| Modular Cognitive Processing TherapyAlso: Modular CPTCPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of Contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need. Modular CPT contains the same core elements of CPT, but content is repackaged into modules instead of sessions so that clinicians can select and dose treatment elements according to patient need. | Behavioural | Early CPT Non-Responders Modular (Group B) |
| Modular Prolonged Exposure TherapyAlso: Modular PEPE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. Modular PE is comprised of the same elements of standard PE, but clinicians select and dose modules (i.e., imaginal exposure, in vivo exposure) based on individual patient need. | Behavioural | Early PE Non-Responders Modular (Group F) |
| Step Down TreatmentAlso: Step DownSelf-managed treatment will involve receiving a self-help version of the remaining treatment materials and ongoing use of the intervention companion app (CPT Coach or PE Coach). | Behavioural | Early CPT Responders Step Down (Group D), Early PE Responders Step Down (Group H) |
| Digital InterventionsAlso: Daily Digital PromptsThe prompt will be a text message delivered through VA-approved technology (e.g., PETALS). | Behavioural | Early CPT Non-Responders Modular (Group B), Early CPT Non-Responders Switch (Group A), Early CPT Responders Continue (Group C), Early CPT Responders Step Down (Group D), Early PE Non-Responders Modular (Group F), Early PE Non-Responsers Switch (Group E), Early PE Responders Continue (Group G), Early PE Responders Step Down (Group H) |
| Cognitive Processing Therapy (CPT)Also: CPTCPT is a first-line treatment for PTSD that includes the following core elements: (a) identification of "stuck points" in thinking that interfere with recovery and (b) using Socratic questioning and a series of progressive worksheets to examine stuck points, develop balanced beliefs, and facilitate the experience of natural emotions. | Behavioural | Early CPT Non-Responders Modular (Group B), Early CPT Non-Responders Switch (Group A), Early CPT Responders Continue (Group C), Early CPT Responders Step Down (Group D), Early PE Non-Responsers Switch (Group E) |
| Prolonged Exposure (PE)Also: PEPE is a first-line treatment for PTSD that includes the following core elements: (a) in vivo exposure and (b) imaginal exposure to the trauma memory. In imaginal exposure, participants repeatedly, systematically approach their trauma memory and related thoughts and feelings. In in vivo exposure, participants repeatedly, systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. | Behavioural | Early CPT Non-Responders Switch (Group A), Early PE Non-Responders Modular (Group F), Early PE Non-Responsers Switch (Group E), Early PE Responders Continue (Group G), Early PE Responders Step Down (Group H) |
Primary outcome
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: 10 weeks, 20 weeks and 9 months
The PCL-5 is a psychometrically valid measure and commonly used assessment of PTSD symptoms. A total score is calculated by adding up the ratings for each of the 20 items, which range from 0 to 4 (0=Not at all, 4=Extremely). Higher scores reflect more severe symptoms. A score below 31 generally suggests a sub-clinical range, while scores of 31 or above fall within the clinical range, indicating probable PTSD.
4 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 10-weeks, 20-weeks, 9-months
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, 10-weeks, 20-weeks, 9-months
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Time frame: Baseline, 20-weeks, 9-months
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Baseline, 10-weeks, 20-weeks, 9-months
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 19 Dec 2025.
- 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.
Stefanie LoSavio, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Rebecca Sripada, PhD principal investigator
VA Ann Arbor-506
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular Cognitive Processing Therapy, Modular Prolonged Exposure Therapy and Step Down Treatment in people with Posttraumatic Stress Disorder and PTSD, run by The University of Texas Health Science Center at San Antonio at 4 sites 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 5 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Stefanie LoSavio, PhD (210-562-6700, losavio@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Disorder Checklist (PCL-5) (time frame: 10 weeks, 20 weeks and 9 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 19 Dec 2025.