Posttraumatic Stress DisorderNCT07656545
Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
A study testing Promotion of Emotional Disclosure for Burns (PoED-B) in people with Posttraumatic Stress Disorder and Burns, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Burns, Traumatic Injury
- What is being tested?
- Promotion of Emotional Disclosure for Burns (PoED-B)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 28 Feb 2029
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alert, oriented, \& not withdrawing from substance at time of screening
- Can read and write in English
- Hospitalized within 10 days of burn injury
- Anticipated discharge <=4 weeks
- Have an email, mailing address, and at least 1 smart device for telehealth sessions
- PTSD risk score of 2 or greater (patient-only)
- Willing to attend therapy sessions with a loved one
Who cannot join
- Currently incarcerated or in police custody
- > 10 days post-burn
- Lifetime diagnosis of primary psychosis or intellectual disability
- Ongoing reported domestic violence in the dyad
- Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury
- Inflammation Confounds (patient-only) of BMI > 40, metabolic syndrome, admission A1C of >= 6.5%
- Currently receiving couples therapy
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
University of Southern California, Keck School of Medicine & Los Angeles General Medical Center
Los Angeles, California, 90033
Sarah Stoycos, PhD, 323-409-7621, sarah.stoycos@med.usc.edu
About this study
The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.
- Conditions
- Posttraumatic Stress Disorder, Burns, Traumatic Injury, Acute Stress Disorder, Trauma and Stressor Related Disorders, Trauma and Stress Related Disorders
- Being tested
- Promotion of Emotional Disclosure for Burns (PoED-B), minimally Enhanced Usual Care control (mEUC)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Burns, Wounds and Injuries, Stress Disorders, Traumatic, Acute, Trauma and Stressor Related Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of Emotional Disclosure for Burns (PoED-B)Behavioural
PoED-B is a dyadic treatment where both patient and identified informal caregiver participate. PoED-B targets reducing disclosure-constraining behaviors (e.g., invalidating, negative statements) using psychoeducation, motivational interviewing, and skills training. The goal is to encourage the patient-caregiver dyad to engage in natural disclosures, supportive responses, and approach coping after the burn trauma to facilitate emotional processing. It is four sessions long. Delivery format takes into account stakeholder feedback, considering overall burden during acute hospitalization and the transition to outpatient care. Sessions one and two are 30 minutes and one week apart. Sessions three and four are 50 minutes long and two weeks apart. Session one must occur during hospitalization. Sessions 2-4 can be completed via video/telehealth if the patient is discharged during the treatment course.
minimally Enhanced Usual Care control (mEUC)Behavioural
mEUC is an individually-administered psychoeducation control for burn patients modeled after minimally enhanced care in acute care surgery units. In one 30-minute session, the therapist reviews with the participant a standardized psychoeducation handout on common psychological reactions after burn injury, giving them time to ask questions or express concerns within a supportive therapy framework. Then, the participant is given the handout, which also includes self-help skills. After study completion, participants will be given referrals for outpatient mental health services.
| Study group | Role | What they receive |
|---|---|---|
| Promotion of Emotional Disclosure for Burns (PoED-B) | Experimental | Participants randomized into this arm will receive Promotion of Emotional Disclosure for Burns (PoED-B), a cognitive behavioral therapy intervention designed for burn survivors and a loved one of their choosing to complete together. The standard treatment length will be 4 sessions, however participants and providers may agree to additional sessions as warranted. Receives: Behavioral: Promotion of Emotional Disclosure for Burns (PoED-B) |
| minimally Enhanced Usual Care control (mEUC) | Active comparator | Participants randomized into this arm will receive a minimally enhanced version of usual burn care. This will include one, 30-minute supportive therapy session focused on psychoeducation about the potential psychological impact of burn injury and hospitalization and referral to outpatient resources, if wanted. Receives: Behavioral: minimally Enhanced Usual Care control (mEUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Constraints Scale
The Social Constraints Scale is a self-report scale administered to both the patient and caregiver. It is designed to assess perceptions of negative reactions to trauma-disclosures. The scale contains 15 items, and each item is scored on a four-point scale ranging from 1 (never) to 4 (often) with total scores ranging from 15 to 60. A higher score indicates a higher frequency of experiencing social constraints.
Measured: Before treatment, immediately after ending treatment, 6-week follow-up
Feasibility of Recruitment
Proportion of participants who agree to participate from the total number of those that are eligible and approached.
Measured: baseline
Feasibility of Data Collection
Proportion of participants who completed each and all assessment timepoints
Measured: From enrollment to the end of study assessments at 6-weeks posttreament
Acceptability: Satisfaction with Treatment
Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability. This measure will be completed by both patients and their loved ones.
Measured: Immediately after ending treatment
Acceptabilitly: Retention
Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.
Measured: Immediately after ending treatment
Acceptability: Global Improvement Rating
Proportion of participants who report overall improvement on the Global Rating of Change Scale
Measured: Immediately after ending treatment
Secondary outcomes (6)
PTSD Checklist for DSM-5 (PCL-5)
The PTSD Checklist for DSM-5 is a 20 item self-report measure assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Measured: Pretreatment, Immediately after ending treatment, 6-week follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 is a structured interview measure of PTSD symptom severity (frequency and intensity) in the past month. Scores can range from 0-80, with higher scores indicating worse symptom severity. Only burn patients will complete this measure, not caregivers.
Measured: Immediately after ending treatment, 6-week follow-up
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale is a 14-item self-report measure of anxiety and depression symptoms that was designed for the hospital environment. Each subscale has 7-items answered on a 4-point scale ranging from 0 to 3, yielding a maximum possible score of 21 for each subscale. Higher scores indicate worse symptoms.
Measured: Pretreatment, immediately after ending treatment, 6-week follow-up
MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)
The MINI is a brief (~15 minutes) structured psychodiagnostic interview for assessing DSM-5 disorders.
Measured: Pretreatment, immediately after ending treatment, 6-week follow-up
Dyadic Relationship Scale (DRS)
The Dyadic Relationship Scale is a self-report survey measuring dyadic strain and positive dyadic interaction specific to patient's health. There is a 10-item patient-version and 11-item caregiver version. Dyadic strain subscale scores range from 0-12 (patient version) and 0-15 (caregiver version). Positive dyadic interaction subscale scores range from 0-18. Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.
Measured: Pretreatment, immediately after ending treatment, 6-week follow-up
Significant Other's Responses to Trauma Scale (SORTS)
The Significant Other's Responses to Trauma Scale is a 14-item self-report measure assessing frequency \& intensity of caregiver PTSD accommodation behaviors. Total scores can range from 0-112 with higher scores indicating greater accommodation.
Measured: Pretreatment, immediately after ending treatment, 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (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.
- More trials run by University of Southern CaliforniaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles General Medical Center, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Stoycos, PhD, Principal investigator, University of Southern California, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656545
- Sponsor's protocol ID
- HS-25-00383
- Other IDs
- 1K23MH141296-01
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA). All data will be de-identified prior to receipt by the repository. Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b). A brief study protocol will also be submitted to NDA and will be made freely available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT07656545
- Acronym / sponsor ID
- HS-25-00383
- Conditions
- Posttraumatic Stress Disorder, Burns, Traumatic Injury, Acute Stress Disorder, Trauma and Stressor Related Disorders, Trauma and Stress Related Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Los Angeles General Medical Center, National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promotion of Emotional Disclosure for Burns (PoED-B) | Experimental | Behavioral: Promotion of Emotional Disclosure for Burns (PoED-B)Participants randomized into this arm will receive Promotion of Emotional Disclosure for Burns (PoED-B), a cognitive behavioral therapy intervention designed for burn survivors and a loved one of their choosing to complete together. The standard treatment length will be 4 sessions, however participants and providers may agree to additional sessions as warranted. |
| minimally Enhanced Usual Care control (mEUC) | Active comparator | Behavioral: minimally Enhanced Usual Care control (mEUC)Participants randomized into this arm will receive a minimally enhanced version of usual burn care. This will include one, 30-minute supportive therapy session focused on psychoeducation about the potential psychological impact of burn injury and hospitalization and referral to outpatient resources, if wanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Alert, oriented, \& not withdrawing from substance at time of screening
- Can read and write in English
- Hospitalized within 10 days of burn injury
- Anticipated discharge <=4 weeks
- Have an email, mailing address, and at least 1 smart device for telehealth sessions
Key exclusion criteria (7 listed)
- Currently incarcerated or in police custody
- > 10 days post-burn
- Lifetime diagnosis of primary psychosis or intellectual disability
- Ongoing reported domestic violence in the dyad
- Unstable bipolar disorder, severe substance use disorder, or acute suicidality with imminent intent that does not remit within 10 days of burn-injury
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 |
|---|---|---|
| Promotion of Emotional Disclosure for Burns (PoED-B)PoED-B is a dyadic treatment where both patient and identified informal caregiver participate. PoED-B targets reducing disclosure-constraining behaviors (e.g., invalidating, negative statements) using psychoeducation, motivational interviewing, and skills training. The goal is to encourage the patient-caregiver dyad to engage in natural disclosures, supportive responses, and approach coping after the burn trauma to facilitate emotional processing. It is four sessions long. Delivery format takes into account stakeholder feedback, considering overall burden during acute hospitalization and the transition to outpatient care. Sessions one and two are 30 minutes and one week apart. Sessions three and four are 50 minutes long and two weeks apart. Session one must occur during hospitalization. Sessions 2-4 can be completed via video/telehealth if the patient is discharged during the treatment course. | Behavioural | Promotion of Emotional Disclosure for Burns (PoED-B) |
| minimally Enhanced Usual Care control (mEUC)mEUC is an individually-administered psychoeducation control for burn patients modeled after minimally enhanced care in acute care surgery units. In one 30-minute session, the therapist reviews with the participant a standardized psychoeducation handout on common psychological reactions after burn injury, giving them time to ask questions or express concerns within a supportive therapy framework. Then, the participant is given the handout, which also includes self-help skills. After study completion, participants will be given referrals for outpatient mental health services. | Behavioural | minimally Enhanced Usual Care control (mEUC) |
Primary outcome
Social Constraints Scale
Time frame: Before treatment, immediately after ending treatment, 6-week follow-up
The Social Constraints Scale is a self-report scale administered to both the patient and caregiver. It is designed to assess perceptions of negative reactions to trauma-disclosures. The scale contains 15 items, and each item is scored on a four-point scale ranging from 1 (never) to 4 (often) with total scores ranging from 15 to 60. A higher score indicates a higher frequency of experiencing social constraints.
Feasibility of Recruitment
Time frame: baseline
Proportion of participants who agree to participate from the total number of those that are eligible and approached.
Feasibility of Data Collection
Time frame: From enrollment to the end of study assessments at 6-weeks posttreament
Proportion of participants who completed each and all assessment timepoints
Acceptability: Satisfaction with Treatment
Time frame: Immediately after ending treatment
Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability. This measure will be completed by both patients and their loved ones.
Acceptabilitly: Retention
Time frame: Immediately after ending treatment
Proportion of enrolled dyads who completed at least 3 out of 4 PoED sessions.
Acceptability: Global Improvement Rating
Time frame: Immediately after ending treatment
Proportion of participants who report overall improvement on the Global Rating of Change Scale
6 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Pretreatment, Immediately after ending treatment, 6-week follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Immediately after ending treatment, 6-week follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up
MINI Montreal International Neuropsychiatric Interview v. 7.0.2 (MINI)
Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up
Dyadic Relationship Scale (DRS)
Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up
Significant Other's Responses to Trauma Scale (SORTS)
Time frame: Pretreatment, immediately after ending treatment, 6-week follow-up
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 18 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA). All data will be de-identified prior to receipt by the repository. Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b). A brief study protocol will also be submitted to NDA and will be made freely available.
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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.
Sarah Stoycos, PhD principal investigator
University of Southern California, Keck School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of Emotional Disclosure for Burns (PoED-B) in people with Posttraumatic Stress Disorder and Burns, run by University of Southern California 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 18 Jun 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 Sarah Stoycos, PhD (323-409-7621, sarah.stoycos@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Constraints Scale (time frame: Before treatment, immediately after ending treatment, 6-week follow-up). The study lists 6 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 18 Jun 2026.