Post Traumatic Stress DisorderNCT07714083
Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress
A study testing Standard CPT and CPT-LEAP in people with Post Traumatic Stress Disorder, run by Boston University at 1 site in United States.
Trial summary
Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Standard CPT and CPT-LEAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 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
- Current diagnosis of PTSD
- Self-identification as a sexual or gender minority (SGM) individual
- Endorsement of SGM stress experiences with moderate distress
- For patients who take psychiatric medication, stable dose one month prior to enrollment
- Reside in Massachusetts.
Who cannot join
- Current active suicidal or homicidal ideation with intent or plan
- Unstable bipolar disorder/current mania
- Unstable psychotic disorder/current psychosis
- Current severe substance use that warrants immediate medical attention
- Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures
- Past completion of CPT or current trauma-focused treatment
- Unwillingness to consent to audio or video recording of assessment and treatment sessions
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
VA Boston Healthcare System
Jamaica Plain, Massachusetts, 02130
Cara Herbitter, PhD, MPH, 857-364-6528, Cara.Herbitter@va.gov
About this study
Official title: Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.
The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.
Read the detailed description
This study will occur in two phases.
Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).
Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Standard CPT, CPT-LEAP
- Keywords
- Cognitive Processing Therapy (CPT), Lived experience stress, Lived Experience Adapted Protocol (LEAP), 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.
Standard CPTBehavioural
CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session.
CPT-LEAPBehavioural
CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP) | Experimental | Participants randomized to this arm will receive the adapted CPT-LEAP treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions). Receives: Behavioral: CPT-LEAP |
| Standard Cognitive Therapy Processing (CPT) | Active comparator | Participants randomized to this arm will receive standard CPT treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions). Receives: Behavioral: Standard CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress disorder symptoms (PTSD)
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5). The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Measured: immediately after treatment, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cara Herbitter, PhD, MPH, Principal investigator, Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714083
- Sponsor's protocol ID
- H-45022
- Other IDs
- 1K23MH133986-01A1
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07714083
- Acronym / sponsor ID
- H-45022
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Cognitive Processing Therapy (CPT), Lived experience stress, Lived Experience Adapted Protocol (LEAP), Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 20 Jul 2026 (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.
Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.
The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.
Detailed description
This study will occur in two phases.
Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).
Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP) | Experimental | Behavioral: CPT-LEAPParticipants randomized to this arm will receive the adapted CPT-LEAP treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions). |
| Standard Cognitive Therapy Processing (CPT) | Active comparator | Behavioral: Standard CPTParticipants randomized to this arm will receive standard CPT treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current diagnosis of PTSD
- Self-identification as a sexual or gender minority (SGM) individual
- Endorsement of SGM stress experiences with moderate distress
- For patients who take psychiatric medication, stable dose one month prior to enrollment
- Reside in Massachusetts.
Key exclusion criteria (7 listed)
- Current active suicidal or homicidal ideation with intent or plan
- Unstable bipolar disorder/current mania
- Unstable psychotic disorder/current psychosis
- Current severe substance use that warrants immediate medical attention
- Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures
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 |
|---|---|---|
| Standard CPTCPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session. | Behavioural | Standard Cognitive Therapy Processing (CPT) |
| CPT-LEAPCPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol. | Behavioural | Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP) |
Primary outcome
Post traumatic stress disorder symptoms (PTSD)
Time frame: immediately after treatment, 3 months
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5). The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
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 30 Sep 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.
Cara Herbitter, PhD, MPH principal investigator
Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard CPT and CPT-LEAP in people with Post Traumatic Stress Disorder, run by Boston University 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 5 inclusion and 7 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 30 Sep 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 Cara Herbitter, PhD, MPH (857-364-6528, Cara.Herbitter@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress disorder symptoms (PTSD) (time frame: immediately after treatment, 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 30 Sep 2026.