Posttraumatic Stress DisorderNCT06670079
Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
A study testing Prolonged exposure therapy + incentives for therapy session attendance in people with Posttraumatic Stress Disorder and Pregnancy, run by University of Vermont at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is: Does PE+ decrease PTSD symptoms? All participants will receive PE+ to see if their PTSD symptoms at the end of the trial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, Pregnancy
- What is being tested?
- Prolonged exposure therapy + incentives for therapy session attendance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 22 Jul 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- >18 years old
- Gestational age ≤ 25 weeks
- Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- Participants receiving psychotropic medications must be maintained on a stable dose for >14 days prior to enrollment.
Who cannot join
- Male
- Under 18 years old
- Gestational age > 25 weeks
- No current diagnosis of PTSD
- Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
- Enrolled in another ongoing evidence-based treatment for PTSD.
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
University of Vermont
Burlington, Vermont, 05401
Kelly Peck, 8026569610, kelly.peck@uvm.edu
About this study
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:
Does PE+ decrease PTSD symptoms?
All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.
Participants will:
- Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
- Receive financial incentives for attending each PE+ session.
- Attend assessment visits every 4 weeks for the 12 weeks of the trial.
- Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.
- Conditions
- Posttraumatic Stress Disorder, Pregnancy
- Being tested
- Prolonged exposure therapy + incentives for therapy session attendance
- 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.
Prolonged exposure therapy + incentives for therapy session attendanceBehavioural
Prolonged exposure therapy plus incentives for therapy session attendance
| Study group | Role | What they receive |
|---|---|---|
| Prolonged exposure therapy + incentives for therapy session attendance | Experimental | Not described Receives: Behavioral: Prolonged exposure therapy + incentives for therapy session attendance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Measured: From baseline to the 12-week assessment
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
Change in treatment acceptability as measured by the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item scale, each with a range of 1-7 and some of which are reverse-scored. The total TAAS score is calculated by summing the score for the 10 TAAS items and the overall TAAS score ranges from 10-70, with higher scores representing better outcomes (greater treatment acceptability).
Measured: From baseline to the 12-week assessment
Secondary outcomes (8)
Change in posttraumatic stress disorder symptom severity - self-reported
Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).
Measured: From baseline to the 12-week assessment
Mean change in subjective units of distress
The mean change in subjective units of distress scale (SUDS) ratings from before each imaginal exposure exercise to the peak (highest) level of distress reported during the exercise measured with a single item (range: 0-100).
Measured: Within 1-hour
Mean percent change in heart rate
The mean percent change in heart rate from before each imaginal exposure exercise to peak (highest) heart rate during the exercise
Measured: Within 1-hour
Change in self-reported posttraumatic stress disorder symptom severity between PE sessions
The percentage of participants who have a reliable exacerbation in PTSD symptoms between sessions
Measured: In the 1 week
Prolonged exposure therapy discontinuation
The percentage of participants who complete <8 prolonged exposure therapy sessions
Measured: From baseline to the 12-week assessment
Neonatal birth weight
Neonatal birth weight in grams
Measured: Delivery
Gestational age at delivery
Gestational age at delivery in weeks
Measured: Delivery
Maternal delivery complications
The percentage of participants who experience delivery complications (i.e., abruption/bleeding, hypertensive disorders, and preterm premature rupture of membranes or preterm labor)
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 Feb 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion22 Jul 2027 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Peck, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670079
- Sponsor's protocol ID
- UVM CHRMS STUDY00002930
- Status last verified
- May 2026
- First submitted
- 28 Oct 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients
- ClinicalTrials.gov ID
- NCT06670079
- Acronym / sponsor ID
- UVM CHRMS STUDY00002930
- Conditions
- Posttraumatic Stress Disorder, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 1 Nov 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.
The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:
Does PE+ decrease PTSD symptoms?
All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.
Participants will:
- Receive individual PE+ therapy for 1 hour weekly for 12 weeks.
- Receive financial incentives for attending each PE+ session.
- Attend assessment visits every 4 weeks for the 12 weeks of the trial.
- Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged exposure therapy + incentives for therapy session attendance | Experimental | Behavioral: Prolonged exposure therapy + incentives for therapy session attendance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- >18 years old
- Gestational age ≤ 25 weeks
- Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- Participants receiving psychotropic medications must be maintained on a stable dose for >14 days prior to enrollment.
Key exclusion criteria (6 listed)
- Male
- Under 18 years old
- Gestational age > 25 weeks
- No current diagnosis of PTSD
- Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
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 |
|---|---|---|
| Prolonged exposure therapy + incentives for therapy session attendanceProlonged exposure therapy plus incentives for therapy session attendance | Behavioural | Prolonged exposure therapy + incentives for therapy session attendance |
Primary outcome
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated
Time frame: From baseline to the 12-week assessment
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Acceptability of prolonged exposure therapy + incentives for therapy session attendance
Time frame: From baseline to the 12-week assessment
Change in treatment acceptability as measured by the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item scale, each with a range of 1-7 and some of which are reverse-scored. The total TAAS score is calculated by summing the score for the 10 TAAS items and the overall TAAS score ranges from 10-70, with higher scores representing better outcomes (greater treatment acceptability).
8 secondary outcomes
Change in posttraumatic stress disorder symptom severity - self-reported
Time frame: From baseline to the 12-week assessment
Mean change in subjective units of distress
Time frame: Within 1-hour
Mean percent change in heart rate
Time frame: Within 1-hour
Change in self-reported posttraumatic stress disorder symptom severity between PE sessions
Time frame: In the 1 week
Prolonged exposure therapy discontinuation
Time frame: From baseline to the 12-week assessment
Neonatal birth weight
Time frame: Delivery
Gestational age at delivery
Time frame: Delivery
Maternal delivery complications
Time frame: Delivery
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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 Prolonged exposure therapy + incentives for therapy session attendance in people with Posttraumatic Stress Disorder and Pregnancy, run by University of Vermont 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 6 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 13 May 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 Kelly Peck, PhD (802-656-9610, kelly.peck@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Stress Disorder Symptom Severity - Clinician Rated (time frame: From baseline to the 12-week assessment). 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?
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 13 May 2026.