PTSDTAPSNCT05486793
Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
A study testing Written Exposure Therapy (WET) and Emotion Focused Supportive Therapy (EFST) in people with PTSD, run by Boston University at 1 site in United States.
Trial summary
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PTSD
- What is being tested?
- Written Exposure Therapy (WET) and Emotion Focused Supportive Therapy (EFST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB/GYN) Department
- Presenting for prenatal care prior to gestational age of 28 weeks
- Meet diagnostic or subthreshold criteria (i.e., endorsement of 3 out of the 4 symptom clusters) for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Who cannot join
- Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)
- Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)
- Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere
- Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility
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
Boston Medical Center and remote
Boston, Massachusetts, 02118
Hannah Brown, MS, 617-358-3324, Hannah.Brown3@bmc.org
About this study
Official title: A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.
Read the detailed description
Pregnant women with posttraumatic stress disorder (PTSD) are at increased risk for adverse pregnancy outcomes, yet the majority of pregnant women with mental health needs do not receive treatment, with disparities in treatment utilization among low-income and racial and ethnic minority women. Perinatal mental health treatment gaps are foremost a consequence of behavioral health workforce shortages and a lack of data on PTSD treatment during pregnancy. Mental health stigma and medical mistrust due to racism further impact engagement in care. Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., time burden of training and delivery). WET has demonstrated non-inferiority (and fewer dropouts) when compared to first-line PTSD treatments. As such, the empirical support and implementation advantages of WET suggest the promise of this intervention in addressing PTSD among pregnant women seen in usual care obstetrics settings. Training non-mental health specialists, such as community health workers (CHWs), to deliver WET may dually address workforce capacity challenges and patient engagement factors such as stigma. The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy against an active control condition [i.e., emotion focused supportive therapy (EFST)] and the non-inferiority of WET delivery with a community health worker (CHW-WET) vs. WET delivery with a mental health clinician. A total of 240 pregnant women with PTSD receiving obstetrical care at Boston Medical Center (BMC), a large safety net hospital that cares for a racially and ethnically diverse population, will be recruited. Following a baseline visit, women will be randomized to either CHW-WET (N=80), standard WET (N=80), or EFST (N=80). Participants in either WET condition will receive 5 individual sessions focused on the use of writing to activate the trauma memory, process emotions, and make meaning. EFST participants will receive 5 individual sessions of supportive therapy. Participants will complete well-established measures of PTSD and other psychological symptoms (e.g., depression) and proposed moderators of treatment engagement at baseline, post-treatment, and 1-, 6-, and 12-months postpartum. Patients and providers will also complete measures and interviews following treatment to assess feasibility, acceptability, and appropriateness of the WET delivery approaches in a usual care setting. Aim 1 is to determine if a) CHW-WET is non-inferior to standard WET and b) CHW-WET has better retention than standard WET. Aim 2 is to demonstrate the effectiveness of WET for treatment of PTSD (vs. EFST) in an obstetrics setting. Exploratory Aim 3 will examine moderators of treatment engagement such as mental health stigma to inform a personalized approach to WET treatment delivery. Aim 4 is to conduct a process evaluation of the WET delivery approaches. This study will inform future efforts to improve access to and quality of care for treatment of PTSD during pregnancy.
- Conditions
- PTSD
- Being tested
- Written Exposure Therapy (WET), Emotion Focused Supportive Therapy (EFST)
- Keywords
- Written Exposure Therapy (WET), Emotion Focused Supportive Therapy (EFST), Community Health Worker (CHW), Antepartum care, perinatal mental health
- 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.
Written Exposure Therapy (WET)Behavioural
5 individual sessions that cover psychoeducation about PTSD, the rationale for exposure treatment, and directing patients to write in session for 30 minutes about their traumatic experience using scripted instructions. Each session includes unique writing instructions. Earlier sessions focus on describing the details of a traumatic stressor linked to their symptoms, with particular attention to felt emotions and thoughts. Later writing sessions focus on writing about the meaning of the traumatic event and how the event has changed their life and how they relate to other people. After writing, therapists spend ~10 minutes processing the patient's experience with the writing. WET does not include between session assignments.
Emotion Focused Supportive Therapy (EFST)Behavioural
5 individual sessions where patients choose what problems to discuss in each session. Therapists validate and clarify patients' emotions and engage in problem solving during sessions.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy (WET) | Experimental | Participants randomized into this arm will receive the WET intervention administered by mental health clinicians. Receives: Behavioral: Written Exposure Therapy (WET) |
| Community Health Workers- Written Exposure Therapy (CHW-WET) | Experimental | Participants randomized into this arm will receive the WET intervention administered by community health workers. Receives: Behavioral: Written Exposure Therapy (WET) |
| Emotion Focused Supportive Therapy (EFST) | Active comparator | Participants randomized into this arm will receive the EFST intervention. Receives: Behavioral: Emotion Focused Supportive Therapy (EFST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5 CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Measured: baseline
Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Measured: 8 weeks
Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Measured: 1 month postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Measured: 6 months postpartum
Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Measured: 12 months postpartum
Secondary outcomes (8)
PTSD Checklist for DSM-5 (PCL-5)
Self-reported PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). Scores range from 0-80, with higher scores indicating greater severity.
Measured: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Patient Health Questionnaire (PHQ-9)
Self-reported depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating greater depressive symptom severity.
Measured: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
Self-reported anxiety symptoms will be assessed using the anxiety scale of the Depression, Anxiety, and Stress scale (DASS-21). Items are summed and then multiplied by 2. Scores range from 0 - 42, with higher scores indicating greater severity.
Measured: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Number of study sessions attended
The number of sessions the participant attended will be documents from 0 to 5.
Measured: 1 month postpartum
Number of participants that completed all 5 study visits
The number of participants that completed all 5 visits will be documented (yes or no)
Measured: 1 month postpartum
Inventory of Psychosocial Functioning (IPF)
Self-reported PTSD-related functional impairment across seven domains (i.e., romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care) will be assessed via the Inventory of Psychosocial Functioning (IPF). Each domain scale is scored independently by summing all completed items and dividing the total by the maximum possible domain scale score for the items included, and then multiplying by 100. Each domain scale yield a score ranging from 0-100, with higher scores indicating greater impairment.
Measured: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Postpartum Bonding Questionnaire (PBQ)
Self-reported maternal-infant bonding will be assessed with the Postpartum Bonding Questionnaire (PBQ). Scores range from 0-125, with higher scores indicating more impaired bonding.
Measured: 1 month postpartum, 6 months postpartum, 12 months postpartum
Client Satisfaction Questionnaire (CSQ-8)
Treatment satisfaction will be assessed with the Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher score indicating greater satisfaction.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Mar 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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.
- 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
- Model description
- Participants will be randomized in a 1:1:1 ratio using a permuted block strategy (random block sizes of 2 and 4) and stratified by PTSD severity (met full PTSD criteria/not) and major depressive diagnosis (MDD).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Yael I Nillni, PhD, Principal investigator, BUSM Department of Psychiatry and VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486793
- Sponsor's protocol ID
- H-42619
- Other IDs
- 1R01HD107282-01A1
- Acronym
- TAPS
- Status last verified
- May 2026
- First submitted
- 2 Aug 2022
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy
- ClinicalTrials.gov ID
- NCT05486793
- Acronym / sponsor ID
- TAPS / H-42619
- Conditions
- PTSD
- Keywords
- Written Exposure Therapy (WET), Emotion Focused Supportive Therapy (EFST), Community Health Worker (CHW), Antepartum care, perinatal mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Aug 2022 (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 majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.
Detailed description
Pregnant women with posttraumatic stress disorder (PTSD) are at increased risk for adverse pregnancy outcomes, yet the majority of pregnant women with mental health needs do not receive treatment, with disparities in treatment utilization among low-income and racial and ethnic minority women. Perinatal mental health treatment gaps are foremost a consequence of behavioral health workforce shortages and a lack of data on PTSD treatment during pregnancy. Mental health stigma and medical mistrust due to racism further impact engagement in care. Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., time burden of training and delivery). WET has demonstrated non-inferiority (and fewer dropouts) when compared to first-line PTSD treatments. As such, the empirical support and implementation advantages of WET suggest the promise of this intervention in addressing PTSD among pregnant women seen in usual care obstetrics settings. Training non-mental health specialists, such as community health workers (CHWs), to deliver WET may dually address workforce capacity challenges and patient engagement factors such as stigma. The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy against an active control condition [i.e., emotion focused supportive therapy (EFST)] and the non-inferiority of WET delivery with a community health worker (CHW-WET) vs. WET delivery with a mental health clinician. A total of 240 pregnant women with PTSD receiving obstetrical care at Boston Medical Center (BMC), a large safety net hospital that cares for a racially and ethnically diverse population, will be recruited. Following a baseline visit, women will be randomized to either CHW-WET (N=80), standard WET (N=80), or EFST (N=80). Participants in either WET condition will receive 5 individual sessions focused on the use of writing to activate the trauma memory, process emotions, and make meaning. EFST participants will receive 5 individual sessions of supportive therapy. Participants will complete well-established measures of PTSD and other psychological symptoms (e.g., depression) and proposed moderators of treatment engagement at baseline, post-treatment, and 1-, 6-, and 12-months postpartum. Patients and providers will also complete measures and interviews following treatment to assess feasibility, acceptability, and appropriateness of the WET delivery approaches in a usual care setting. Aim 1 is to determine if a) CHW-WET is non-inferior to standard WET and b) CHW-WET has better retention than standard WET. Aim 2 is to demonstrate the effectiveness of WET for treatment of PTSD (vs. EFST) in an obstetrics setting. Exploratory Aim 3 will examine moderators of treatment engagement such as mental health stigma to inform a personalized approach to WET treatment delivery. Aim 4 is to conduct a process evaluation of the WET delivery approaches. This study will inform future efforts to improve access to and quality of care for treatment of PTSD during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio using a permuted block strategy (random block sizes of 2 and 4) and stratified by PTSD severity (met full PTSD criteria/not) and major depressive diagnosis (MDD).
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy (WET) | Experimental | Behavioral: Written Exposure Therapy (WET)Participants randomized into this arm will receive the WET intervention administered by mental health clinicians. |
| Community Health Workers- Written Exposure Therapy (CHW-WET) | Experimental | Behavioral: Written Exposure Therapy (WET)Participants randomized into this arm will receive the WET intervention administered by community health workers. |
| Emotion Focused Supportive Therapy (EFST) | Active comparator | Behavioral: Emotion Focused Supportive Therapy (EFST)Participants randomized into this arm will receive the EFST intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB/GYN) Department
- Presenting for prenatal care prior to gestational age of 28 weeks
- Meet diagnostic or subthreshold criteria (i.e., endorsement of 3 out of the 4 symptom clusters) for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Key exclusion criteria (4 listed)
- Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)
- Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)
- Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere
- Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility
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 Therapy (WET)5 individual sessions that cover psychoeducation about PTSD, the rationale for exposure treatment, and directing patients to write in session for 30 minutes about their traumatic experience using scripted instructions. Each session includes unique writing instructions. Earlier sessions focus on describing the details of a traumatic stressor linked to their symptoms, with particular attention to felt emotions and thoughts. Later writing sessions focus on writing about the meaning of the traumatic event and how the event has changed their life and how they relate to other people. After writing, therapists spend ~10 minutes processing the patient's experience with the writing. WET does not include between session assignments. | Behavioural | Community Health Workers- Written Exposure Therapy (CHW-WET), Written Exposure Therapy (WET) |
| Emotion Focused Supportive Therapy (EFST)5 individual sessions where patients choose what problems to discuss in each session. Therapists validate and clarify patients' emotions and engage in problem solving during sessions. | Behavioural | Emotion Focused Supportive Therapy (EFST) |
Primary outcome
Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline
Time frame: baseline
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5 CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks
Time frame: 8 weeks
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum
Time frame: 1 month postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum
Time frame: 6 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum
Time frame: 12 months postpartum
PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.
8 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5)
Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Number of study sessions attended
Time frame: 1 month postpartum
Number of participants that completed all 5 study visits
Time frame: 1 month postpartum
Inventory of Psychosocial Functioning (IPF)
Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
Postpartum Bonding Questionnaire (PBQ)
Time frame: 1 month postpartum, 6 months postpartum, 12 months postpartum
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 8 weeks
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 28 May 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.
Yael I Nillni, PhD principal investigator
BUSM Department of Psychiatry and 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 Written Exposure Therapy (WET) and Emotion Focused Supportive Therapy (EFST) in people with PTSD, 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 3 inclusion and 4 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 28 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 Yael I Nillni, PhD (781-413-6319, yael.nillni@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline (time frame: baseline). The study lists 5 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 28 May 2026.