PTSD (Childbirth-Related)CARESNCT05662423
Preventing Childbirth-Related PTSD With Expressive Writing
A study testing Expressive Writing about Childbirth and Neutral Writing in people with PTSD (Childbirth-Related), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD (Childbirth-Related)
- What is being tested?
- Expressive Writing about Childbirth and Neutral Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 29 Jul 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who recently delivered at Massachusetts General Hospital (MGH).
- Women who are at risk for developing CB-PTSD based on their scoring of >16 on the Peritraumatic Distress Inventory (PDI).
Who cannot join
- Age <18 or >50.
- Stillbirth.
- Down's Syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida).
- Admission to the neonatal intensive care unit (NICU) for more than 1 week or infant that is not medically healthy.
- Current diagnosable DSM-5 psychotic or bipolar disorder, or current substance abuse disorder.
- Active suicidality (assessed case by case).
Show all 11Show fewer
- Present substance abuse as indicated in medical records.
- Severe maternal morbidity (assessed case by case).
- General anesthesia.
- Inability to understand the study procedures, risks, and side effects, or to otherwise give informed consent for participation due to neurological or other reasons.
- Inability to understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
Official title: The Effects of Expressive Writing Following Traumatic Childbirth
The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding.
In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum (with the option of up to around Month 3 PP), participants will take part in mental health and physiological assessments, and in a brief play session with their infant.
Read the detailed description
Childbirth-related PTSD (CB-PTSD) is a debilitating maternal mental disorder that undermines the well-being of mothers and can interfere with bonding with their infants during an important time of infant development. A significant portion of delivering women, particularly those who have experienced complicated deliveries, are at-risk for developing CB-PTSD. Underrepresented minorities are also at higher risk for CB-PTSD. An estimated 240,000 American women are likely to be affected by CB-PTSD each year.
Currently, there is no recommended intervention for individuals exposed to traumatic childbirth in hospitals in the United States. Immediate postpartum interventions delivered to at-risk women that are low-cost, low-burden, and feasible are lacking. This study will attempt to fill this gap in effective treatment. Evidence shows that expressive writing (EW), or briefly disclosing in writing mainly thoughts and feelings about a highly stressful event, can have positive effects on mental and physical health. Therefore, the investigators will test the therapeutic effects of EW about recent childbirth in women at-risk for CB-PTSD.
- Conditions
- PTSD (Childbirth-Related)
- Being tested
- Expressive Writing about Childbirth, Neutral Writing
- Keywords
- Mother-Infant Bonding, Postpartum Depression, Postpartum PTSD, Expressive Writing
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive Writing about ChildbirthBehavioural
Participants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences.
Neutral WritingBehavioural
Participants will write repeatedly about neutral daily events/tasks not related to childbirth.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Writing about Childbirth | Active comparator | Subgroup of participants will write about their recent childbirth. Receives: Behavioral: Expressive Writing about Childbirth |
| Neutral Writing | Placebo comparator | Subgroup of participants will write about neutral daily events. Receives: Behavioral: Neutral Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Measured: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Measured: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
The posterior probability score will be determined for each participant from a composite of psychophysiological responses during script-driven imagery of recent traumatic childbirth (in comparison to baseline) that includes assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator frontalis facial muscle electromyogram (EMG) responses in microVolts. The responses to each childbirth script will then be compared with a large database of trauma-exposed subjects by means of a discriminant function analysis, which will yield a posterior probability (PrP) score (higher scores means worse outcome). The PrP scores of the two childbirth scripts will be averaged and will serve as a composite measure of physiological responsivity in the analysis.
Measured: Month 2 postpartum (up to around Month 3 PP)
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
The CAPS-5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of diagnosis and a severity score (scale: 0-80, higher scores means worse outcomes).
Measured: Month 2 postpartum (up to around Month 3 PP)
Secondary outcomes (9)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome). This will be assessed in relation to recent childbirth.
Measured: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
The MIBS is a simply designed short self-report measure for use from day one postpartum, offering one-word descriptors of possible emotions towards the baby to identify early difficulties in bonding (scale: 0-24, higher scores means worse outcome).This will be assessed in relation to recent childbirth.
Measured: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Maternal Attachment Inventory (MAI) total score
The MAI self-report asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Measured: Post-intervention (within 1 day of treatment)
Maternal Attachment Inventory (MAI) total score
The MAI asks about maternal feelings toward and perceptions of the infant; it is considered a robust tool to measure problems in mother-baby relationship (scale: 26-104, higher scores means better outcome).This will be assessed in relation to recent childbirth.
Measured: Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.
Measured: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
The EPDS is a brief 10-item self-report measure (scale: 0-30, higher scores means worse outcome). It recommended for assessing for maternal depression in routine obstetrics care in the US.
Measured: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the posttraumatic growth inventory (PTG) total score
The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Measured: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the posttraumatic growth inventory (PTG) total score
The PTGI is a 21-item self-report measures that in used in research to assess positive change following a specific (potentially traumatic) event in regard to new possibilities, relating to others, personal strength, spiritual change, and appreciation of Life (scale: 0-125, higher scores means better outcome). This will be assessed in relation to recent childbirth.
Measured: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)
Mother-infant bonding behavior will be observed during a 5-min free-play session and coded using the well-validated CIB. The CIB is a global rating system that looks at affective states and interactive styles. Using video-recorded material, the CIB is broken down into 33 codes (18 parent, 8 child, and 7 dyad) rated on a 1-5 scale. Meaningful theory-based constructs, for example, maternal sensitivity (higher scores better outcome), will be used in final analysis
Measured: Month 2 postpartum (up to around Month 3 PP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start8 Nov 2023
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PTSD (Childbirth-Related)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Dekel, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662423
- Sponsor's protocol ID
- 2022P003320
- Acronym
- CARES
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yildiz PD, Ayers S, Phillips L. The prevalence of posttraumatic stress disorder in pregnancy and after birth: A systematic review and meta-analysis. J Affect Disord. 2017 Jan 15;208:634-645. doi: 10.1016/j.jad.2016.10.009. Epub 2016 Oct 27.
PubMed 27865585Pennebaker JW. Expressive Writing in Psychological Science. Perspect Psychol Sci. 2018 Mar;13(2):226-229. doi: 10.1177/1745691617707315. Epub 2017 Oct 9.
PubMed 28992443Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. doi: 10.1016/0005-7967(93)90105-4.
PubMed 8347112Dekel S, Thiel F, Dishy G, Ashenfarb AL. Is childbirth-induced PTSD associated with low maternal attachment? Arch Womens Ment Health. 2019 Feb;22(1):119-122. doi: 10.1007/s00737-018-0853-y. Epub 2018 May 21.
PubMed 29786116Dekel S, Stuebe C, Dishy G. Childbirth Induced Posttraumatic Stress Syndrome: A Systematic Review of Prevalence and Risk Factors. Front Psychol. 2017 Apr 11;8:560. doi: 10.3389/fpsyg.2017.00560. eCollection 2017.
PubMed 28443054Chan SJ, Thiel F, Kaimal AJ, Pitman RK, Orr SP, Dekel S. Validation of childbirth-related posttraumatic stress disorder using psychophysiological assessment. Am J Obstet Gynecol. 2022 Oct;227(4):656-659. doi: 10.1016/j.ajog.2022.05.051. Epub 2022 May 29.
PubMed 35640702Dekel S, Ein-Dor T, Dishy GA, Mayopoulos PA. Beyond postpartum depression: posttraumatic stress-depressive response following childbirth. Arch Womens Ment Health. 2020 Aug;23(4):557-564. doi: 10.1007/s00737-019-01006-x. Epub 2019 Oct 25.
PubMed 31650283Berman Z, Thiel F, Dishy GA, Chan SJ, Dekel S. Maternal psychological growth following childbirth. Arch Womens Ment Health. 2021 Apr;24(2):313-320. doi: 10.1007/s00737-020-01053-9. Epub 2020 Jul 23.
PubMed 32705348
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Expressive Writing Following Traumatic Childbirth
- ClinicalTrials.gov ID
- NCT05662423
- Acronym / sponsor ID
- CARES / 2022P003320
- Conditions
- PTSD (Childbirth-Related)
- Keywords
- Mother-Infant Bonding, Postpartum Depression, Postpartum PTSD, Expressive Writing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 22 Dec 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 goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding.
In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum (with the option of up to around Month 3 PP), participants will take part in mental health and physiological assessments, and in a brief play session with their infant.
Detailed description
Childbirth-related PTSD (CB-PTSD) is a debilitating maternal mental disorder that undermines the well-being of mothers and can interfere with bonding with their infants during an important time of infant development. A significant portion of delivering women, particularly those who have experienced complicated deliveries, are at-risk for developing CB-PTSD. Underrepresented minorities are also at higher risk for CB-PTSD. An estimated 240,000 American women are likely to be affected by CB-PTSD each year.
Currently, there is no recommended intervention for individuals exposed to traumatic childbirth in hospitals in the United States. Immediate postpartum interventions delivered to at-risk women that are low-cost, low-burden, and feasible are lacking. This study will attempt to fill this gap in effective treatment. Evidence shows that expressive writing (EW), or briefly disclosing in writing mainly thoughts and feelings about a highly stressful event, can have positive effects on mental and physical health. Therefore, the investigators will test the therapeutic effects of EW about recent childbirth in women at-risk for CB-PTSD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing about Childbirth | Active comparator | Behavioral: Expressive Writing about ChildbirthSubgroup of participants will write about their recent childbirth. |
| Neutral Writing | Placebo comparator | Behavioral: Neutral WritingSubgroup of participants will write about neutral daily events. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who recently delivered at Massachusetts General Hospital (MGH).
- Women who are at risk for developing CB-PTSD based on their scoring of >16 on the Peritraumatic Distress Inventory (PDI).
Key exclusion criteria (11 listed)
- Age <18 or >50.
- Stillbirth.
- Down's Syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida).
- Admission to the neonatal intensive care unit (NICU) for more than 1 week or infant that is not medically healthy.
- Current diagnosable DSM-5 psychotic or bipolar disorder, or current substance abuse disorder.
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 |
|---|---|---|
| Expressive Writing about ChildbirthParticipants will write repeatedly about their deepest emotions and thoughts related to their recent childbirth, focusing on the most stressful experiences. | Behavioural | Expressive Writing about Childbirth |
| Neutral WritingParticipants will write repeatedly about neutral daily events/tasks not related to childbirth. | Behavioural | Neutral Writing |
Primary outcome
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
The PCL-5 is the standard self-report measure to assess PTSD symptom severity. It lists the 20 DSM-5 symptoms regarding a specified event (scale: 0-80, higher scores means worse outcome). In this study the event is specified to recent personal childbirth.
Physiological reactivity as determined from psychophysiologic responses during script-driven traumatic memory recollection of recent childbirth
Time frame: Month 2 postpartum (up to around Month 3 PP)
The posterior probability score will be determined for each participant from a composite of psychophysiological responses during script-driven imagery of recent traumatic childbirth (in comparison to baseline) that includes assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator frontalis facial muscle electromyogram (EMG) responses in microVolts. The responses to each childbirth script will then be compared with a large database of trauma-exposed subjects by means of a discriminant function analysis, which will yield a posterior probability (PrP) score (higher scores means worse outcome). The PrP scores of the two childbirth scripts will be averaged and will serve as a composite measure of physiological responsivity in the analysis.
Clinician-Administered PTSD-5 Scale for DSM 5 (CAPS-5)
Time frame: Month 2 postpartum (up to around Month 3 PP)
The CAPS-5 is the gold-standard interview to diagnose PTSD. It yields a categorical measure of diagnosis and a severity score (scale: 0-80, higher scores means worse outcomes).
9 secondary outcomes
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Mother-to-Infant Bonding Scale (MIBS) total score
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Maternal Attachment Inventory (MAI) total score
Time frame: Post-intervention (within 1 day of treatment)
Maternal Attachment Inventory (MAI) total score
Time frame: Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the Edinburgh Postnatal Depression Scale (EPDS) total score
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Change from baseline in the posttraumatic growth inventory (PTG) total score
Time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)
Change from baseline in the posttraumatic growth inventory (PTG) total score
Time frame: Pre-Intervention and Month 2 postpartum (up to around Month 3 PP)
Behavioral mother-infant bonding as determined by a quantitative observational assessment of mother-infant interaction using the Coding Interactive Behavior (CIB)
Time frame: Month 2 postpartum (up to around Month 3 PP)
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 30 Jul 2026.
- Background: PubMed 27865585Yildiz PD, Ayers S, Phillips L. The prevalence of posttraumatic stress disorder in pregnancy and after birth: A systematic review and meta-analysis. J Affect Disord. 2017 Jan 15;208:634-645. doi: 10.1016/j.jad.2016.10.009. Epub 2016 Oct 27.
- Background: PubMed 28992443Pennebaker JW. Expressive Writing in Psychological Science. Perspect Psychol Sci. 2018 Mar;13(2):226-229. doi: 10.1177/1745691617707315. Epub 2017 Oct 9.
- Background: PubMed 8347112Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. doi: 10.1016/0005-7967(93)90105-4.
- Background: PubMed 29786116Dekel S, Thiel F, Dishy G, Ashenfarb AL. Is childbirth-induced PTSD associated with low maternal attachment? Arch Womens Ment Health. 2019 Feb;22(1):119-122. doi: 10.1007/s00737-018-0853-y. Epub 2018 May 21.
- Background: PubMed 28443054Dekel S, Stuebe C, Dishy G. Childbirth Induced Posttraumatic Stress Syndrome: A Systematic Review of Prevalence and Risk Factors. Front Psychol. 2017 Apr 11;8:560. doi: 10.3389/fpsyg.2017.00560. eCollection 2017.
- Background: PubMed 35640702Chan SJ, Thiel F, Kaimal AJ, Pitman RK, Orr SP, Dekel S. Validation of childbirth-related posttraumatic stress disorder using psychophysiological assessment. Am J Obstet Gynecol. 2022 Oct;227(4):656-659. doi: 10.1016/j.ajog.2022.05.051. Epub 2022 May 29.
- Background: PubMed 31650283Dekel S, Ein-Dor T, Dishy GA, Mayopoulos PA. Beyond postpartum depression: posttraumatic stress-depressive response following childbirth. Arch Womens Ment Health. 2020 Aug;23(4):557-564. doi: 10.1007/s00737-019-01006-x. Epub 2019 Oct 25.
- Background: PubMed 32705348Berman Z, Thiel F, Dishy GA, Chan SJ, Dekel S. Maternal psychological growth following childbirth. Arch Womens Ment Health. 2021 Apr;24(2):313-320. doi: 10.1007/s00737-020-01053-9. Epub 2020 Jul 23.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing about Childbirth and Neutral Writing in people with PTSD (Childbirth-Related), run by Massachusetts General Hospital 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 2 inclusion and 11 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 30 Jul 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. Some participants in this study may receive a placebo. 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?
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score (time frame: Pre-Intervention and Post-Intervention (within 1 day of treatment)). The study lists 4 primary outcomes in all. 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 NCT05662423, which also lists 8 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 30 Jul 2026.