Post-Traumatic Stress Disorder in AdolescenceEMPWRNCT06771817
Empowering Perinatal Adolescents Through Writing
A study testing Written Exposure Therapy in people with Post-Traumatic Stress Disorder in Adolescence and PTSD - Post Traumatic Stress Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder in Adolescence, PTSD - Post Traumatic Stress Disorder, PTSD and Trauma-related Symptoms
- What is being tested?
- Written Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Have been referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up
- Aged 15-24 at time of screening
- Either have Gestational age >12 weeks or be <1 year postpartum at time of screening
- Able and willing to provide informed consent if 18 years of age or above or the legal guardian must be able and willing to provide informed consent if participant is less than 18 years of age and participant willing and able to provide assent if less than 18 years of age
- Able to read, write and speak in English and Spanish; if the participant is under age 18, parents must be able to understand spoken or written English or Spanish.
- Have the ability to complete clinical evaluations and self-report measures.
- Meet diagnostic or subthreshold criteria for PTSD.
Who cannot join
- Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
- Have current mania, hypomania, or psychosis
- Be at serious suicidal risk that cannot be managed in the outpatient setting
- Pervasive or intellectual developmental disorder requiring substantial or very substantial support.
- Currently receiving or having received course of exposure-based therapy (e.g. WET, PE, CPT, or TF-CBT) in the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Center for Depression Research and Clinical Care
Dallas, Texas, 75247
About this study
Official title: Feasibility and Preliminary Effectiveness of Written Exposure Therapy (WET) for Pregnant or Postpartum Adolescents and Youth With Post-Traumatic Stress Disorder (PTSD) in an Open Pilot Trial
This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.
Read the detailed description
The main goal of this research study is to investigate whether a short trauma-focused therapy involving writing is something teens and young adults who are pregnant or recently had a baby and have symptoms related to post-traumatic stress disorder (PTSD) are able to complete. This study is specifically examining the feasibility and acceptability of Written Exposure Therapy (WET) as a treatment in this population. WET is a type of therapy where people write about a traumatic experience they have gone through, and their feelings about the event. Doing this over several sessions may help some people reduce how distressing the memory is to them over time.
In addition, this study aims to investigate if WET can reduce symptoms related to PTSD in teens and young adults who are pregnant or have had a baby in the last year. The study will also explore if it is possible to gather enough information on measurements like heart rate and sleep patterns with smart watches in the same population, to look at brain patterns before and after the therapy, and to see if WET can improve emotions, functioning, and relationships in pregnant and post-partum individuals.
Prior to initiating the course of WET, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete 5 sessions of written exposure therapy, one session per week and biomarker data will be collected via a wearable device. Participants will also undergo optional electroencephalography (EEG) as well as self-report and clinician-rated assessments. Follow-up visits will be conducted at 4, 8 and 12 weeks post-baseline (post-treatment for WET), with weekly assessments.
The baseline visit must be done in-person in order to set up the smart watch. If participants choose to undergo electroencephalography, they will be required to come in-person for the procedure.
- Conditions
- Post-Traumatic Stress Disorder in Adolescence, PTSD - Post Traumatic Stress Disorder, PTSD and Trauma-related Symptoms, Pregnancy and PTSD
- Being tested
- Written Exposure Therapy
- Keywords
- PTSD, post-traumatic stress disorder, post-partum, pregnant, adolescent, adolescent PTSD, trauma, written exposure therapy, therapy, adolescent pregnancy, written exposure
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
WET may be an optimal treatment for pregnant or postpartum adolescents and youth with PTSD in a low resource setting. WET addresses many of the barriers above. It is delivered in just 5 sessions, with no homework, and may promote a sense of self-efficacy in adolescents and youth due to the nature of writing assignments and brief therapist involvement. It is attractive in resource-poor settings because just 10-15 min of direct therapist time per follow-up session is needed.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | All participants will receive written exposure therapy Receives: Behavioral: Written Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Written Exposure Therapy
Feasibility will be assessed based on recruitment, retention and treatment adherence rates. Acceptability will be evaluated through participant feedback, including satisfaction with the intervention and willingness to engage in treatment. The primary outcome will be the percentage of participants who complete treatment within 4 weeks, for a 12-week study period. We expect at least 70% of participants will be able to complete treatment within 4 weeks.
Measured: From enrollment to study exit visit at week 12
Secondary outcomes (5)
Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5) is a 30-item clinician-administered PTSD scale based upon DSM-5 criteria for children and adolescents ages 7 and above. It is a modified version of the CAPS-5 that includes age-appropriate items and picture response options. It will be used to diagnose PTSD or subthreshold PTSD and obtain data on the frequency and severity of PTSD symptoms. The worst traumatic event identified in the LSC-R from baseline will be used for all CAPS-CA-5 administrations. Preliminary effectiveness will be measured by assessing changes in the CAPS-5 score at 4,8, and 12 weeks after baseline visit.
Measured: From enrollment to study exit visit at week 12
Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80 and a score above 21 is indicative of probable PTSD. A 10-20 point change represents clinically significant change.
Measured: From enrollment to study exit visit at week 12
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure to evaluate sleep quality, duration, and functioning.
Measured: From enrollment to study exit visit at week 12
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a 16-item assessment of emotion regulation difficulties, rated on a 5-point Likert scale.
Measured: From enrollment to study exit visit at week 12
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
The Perinatal Anxiety Screening Scale (PASS) is a 31-item self-rated questionnaire investigating anxiety symptoms during the last month in child-bearing women. Scores may range 0-93 and cutoff for clinical anxiety is ≥26.
Measured: From enrollment to study exit visit at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start26 Mar 2025
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder in AdolescenceStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Child Mental Healthcare Consortium (TCMHCC)
- Responsible party
- Principal investigator, Nabila Haque, University of Texas Southwestern Medical Center
- Investigators
- Nabila Haque, MD., PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771817
- Sponsor's protocol ID
- STU-2024-1115
- Other IDs
- NECMHR01-FY24 -060
- Acronym
- EMPWR
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadi SJ, Musavi Z, Samim N, Sadeqi M, Jobson L. Investigating the Feasibility, Acceptability and Efficacy of Using Modified-Written Exposure Therapy in the Aftermath of a Terrorist Attack on Symptoms of Posttraumatic Stress Disorder Among Afghan Adolescent Girls. Front Psychiatry. 2022 Apr 8;13:826633. doi: 10.3389/fpsyt.2022.826633. eCollection 2022.
PubMed 35463492Nillni YI, Baul TD, Paul E, Godfrey LB, Sloan DM, Valentine SE. Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Gen Hosp Psychiatry. 2023 Jul-Aug;83:66-74. doi: 10.1016/j.genhosppsych.2023.04.013. Epub 2023 Apr 24.
PubMed 37119780
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of Written Exposure Therapy (WET) for Pregnant or Postpartum Adolescents and Youth With Post-Traumatic Stress Disorder (PTSD) in an Open Pilot Trial
- ClinicalTrials.gov ID
- NCT06771817
- Acronym / sponsor ID
- EMPWR / STU-2024-1115
- Conditions
- Post-Traumatic Stress Disorder in Adolescence, PTSD - Post Traumatic Stress Disorder, PTSD and Trauma-related Symptoms, Pregnancy and PTSD
- Keywords
- PTSD, post-traumatic stress disorder, post-partum, pregnant, adolescent, adolescent PTSD, trauma, written exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Child Mental Healthcare Consortium (TCMHCC)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 13 Jan 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.
This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.
Detailed description
The main goal of this research study is to investigate whether a short trauma-focused therapy involving writing is something teens and young adults who are pregnant or recently had a baby and have symptoms related to post-traumatic stress disorder (PTSD) are able to complete. This study is specifically examining the feasibility and acceptability of Written Exposure Therapy (WET) as a treatment in this population. WET is a type of therapy where people write about a traumatic experience they have gone through, and their feelings about the event. Doing this over several sessions may help some people reduce how distressing the memory is to them over time.
In addition, this study aims to investigate if WET can reduce symptoms related to PTSD in teens and young adults who are pregnant or have had a baby in the last year. The study will also explore if it is possible to gather enough information on measurements like heart rate and sleep patterns with smart watches in the same population, to look at brain patterns before and after the therapy, and to see if WET can improve emotions, functioning, and relationships in pregnant and post-partum individuals.
Prior to initiating the course of WET, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete 5 sessions of written exposure therapy, one session per week and biomarker data will be collected via a wearable device. Participants will also undergo optional electroencephalography (EEG) as well as self-report and clinician-rated assessments. Follow-up visits will be conducted at 4, 8 and 12 weeks post-baseline (post-treatment for WET), with weekly assessments.
The baseline visit must be done in-person in order to set up the smart watch. If participants choose to undergo electroencephalography, they will be required to come in-person for the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: Written Exposure TherapyAll participants will receive written exposure therapy |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Have been referred by a clinician to the study or receiving standard of care treatment for pregnancy or post-partum follow-up
- Aged 15-24 at time of screening
- Either have Gestational age >12 weeks or be <1 year postpartum at time of screening
- Able and willing to provide informed consent if 18 years of age or above or the legal guardian must be able and willing to provide informed consent if participant is less than 18 years of age and participant willing and able to provide assent if less than 18 years of age
Key exclusion criteria (5 listed)
- Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
- Have current mania, hypomania, or psychosis
- Be at serious suicidal risk that cannot be managed in the outpatient setting
- Pervasive or intellectual developmental disorder requiring substantial or very substantial support.
- Currently receiving or having received course of exposure-based therapy (e.g. WET, PE, CPT, or TF-CBT) in the past six months
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 |
|---|---|---|
| Written Exposure TherapyWET may be an optimal treatment for pregnant or postpartum adolescents and youth with PTSD in a low resource setting. WET addresses many of the barriers above. It is delivered in just 5 sessions, with no homework, and may promote a sense of self-efficacy in adolescents and youth due to the nature of writing assignments and brief therapist involvement. It is attractive in resource-poor settings because just 10-15 min of direct therapist time per follow-up session is needed. | Behavioural | Written Exposure Therapy |
Primary outcome
Feasibility of Written Exposure Therapy
Time frame: From enrollment to study exit visit at week 12
Feasibility will be assessed based on recruitment, retention and treatment adherence rates. Acceptability will be evaluated through participant feedback, including satisfaction with the intervention and willingness to engage in treatment. The primary outcome will be the percentage of participants who complete treatment within 4 weeks, for a 12-week study period. We expect at least 70% of participants will be able to complete treatment within 4 weeks.
5 secondary outcomes
Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)
Time frame: From enrollment to study exit visit at week 12
Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
Time frame: From enrollment to study exit visit at week 12
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to study exit visit at week 12
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: From enrollment to study exit visit at week 12
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
Time frame: From enrollment to study exit visit at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 35463492Ahmadi SJ, Musavi Z, Samim N, Sadeqi M, Jobson L. Investigating the Feasibility, Acceptability and Efficacy of Using Modified-Written Exposure Therapy in the Aftermath of a Terrorist Attack on Symptoms of Posttraumatic Stress Disorder Among Afghan Adolescent Girls. Front Psychiatry. 2022 Apr 8;13:826633. doi: 10.3389/fpsyt.2022.826633. eCollection 2022.
- Background: PubMed 37119780Nillni YI, Baul TD, Paul E, Godfrey LB, Sloan DM, Valentine SE. Written exposure therapy for treatment of perinatal PTSD among women with comorbid PTSD and SUD: A pilot study examining feasibility, acceptability, and preliminary effectiveness. Gen Hosp Psychiatry. 2023 Jul-Aug;83:66-74. doi: 10.1016/j.genhosppsych.2023.04.013. Epub 2023 Apr 24.
- 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. This study is not recruiting at the moment.
Nabila Haque, MD., PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy in people with Post-Traumatic Stress Disorder in Adolescence and PTSD - Post Traumatic Stress Disorder, run by University of Texas Southwestern 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 8 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: finished, as of the sponsor's last update on 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Written Exposure Therapy (time frame: From enrollment to study exit visit at week 12). 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 NCT06771817, which also lists 2 linked publications.
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 15 Sep 2026.