PTSDNCT03803332
A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
A study testing Exposure Therapy and Interpersonal Psychotherapy in people with PTSD, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PTSD
- What is being tested?
- Exposure Therapy and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to Sep 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn
- Diagnosed with PTSD consequent to MST, with a minimum CAPS score > 40
- Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)
- Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
- Stable on psychotropic medication for the prior 60 days
Who cannot join
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder
- Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months
- Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments
- Patients who in the investigator's judgment pose a current homicidal or suicidal risk
- Current or history of substance dependence in the past 90 days.
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
Weill Cornell Medicine
New York, New York, 10065
Olivia Baryluk, BS, 212-821-0783, olb4002@med.cornell.edu
About this study
Official title: A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.
- Conditions
- PTSD
- Being tested
- Exposure Therapy, Interpersonal Psychotherapy
- Keywords
- PTSD, Military Sexual Trauma, exposure therapy, interpersonal psychotherapy, treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Military Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure TherapyBehavioural
Also called Prolonged Exposure
Psychotherapy including imaginal and in vivo exposure for PTSD.
Interpersonal PsychotherapyBehavioural
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Therapy | Active comparator | Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual. Receives: Behavioral: Exposure Therapy |
| Interpersonal Psychotherapy | Active comparator | Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life. Receives: Behavioral: Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Measured: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Measured: Baseline, 11 weeks
Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Measured: Baseline, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start9 Mar 2020
- Primary completionMar 2027 (estimated)
- Study completionSep 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803332
- Sponsor's protocol ID
- 1409015511
- Other IDs
- W81XWH-16-R-BAA1
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2019
- Last updated
- 16 Apr 2026
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
- ClinicalTrials.gov ID
- NCT03803332
- Acronym / sponsor ID
- 1409015511
- Conditions
- PTSD
- Keywords
- PTSD, Military Sexual Trauma, exposure therapy, interpersonal psychotherapy, treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Jan 2019 (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.
The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Therapy | Active comparator | Behavioral: Exposure TherapyParticipants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual. |
| Interpersonal Psychotherapy | Active comparator | Behavioral: Interpersonal PsychotherapyParticipants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn
- Diagnosed with PTSD consequent to MST, with a minimum CAPS score > 40
- Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)
- Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
Key exclusion criteria (5 listed)
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder
- Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months
- Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments
- Patients who in the investigator's judgment pose a current homicidal or suicidal risk
- Current or history of substance dependence in the past 90 days.
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 |
|---|---|---|
| Exposure TherapyAlso: Prolonged ExposurePsychotherapy including imaginal and in vivo exposure for PTSD. | Behavioural | Exposure Therapy |
| Interpersonal PsychotherapyPsychotherapy that focuses on the effects of PTSD on current interpersonal functioning. | Behavioural | Interpersonal Psychotherapy |
Primary outcome
Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment
Time frame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group
Time frame: Baseline, 11 weeks
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
Time frame: Baseline, 15 weeks
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
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 16 Apr 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.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy and Interpersonal Psychotherapy in people with PTSD, run by Weill Medical College of Cornell 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 6 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 16 Apr 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 Olivia Baryluk, BS (212-821-0783, olb4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment (time frame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition). The study lists 3 primary outcomes in all. 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 16 Apr 2026.