Military Sexual TraumaMIRRORNCT06988787
Multifaceted Intervention to Restore Resilience and Overcome Risk
A study testing webSTAIR, ExpoTx and PsychoEd in people with Military Sexual Trauma and Intimate Partner Violence, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Military Sexual Trauma, Intimate Partner Violence, Brain Injury
- What is being tested?
- webSTAIR, ExpoTx and PsychoEd
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to consent as determined by UBACC, are English-speaking FVets who are 18+ years old
- Screen positive for exposure to IPV and/or MST using the VA Intimate Partner Violence Assistance Program (VA IPVAP) and MST Screening Protocol,
- Have a history of at least one BI assessed using the BISQ+IPV,
- Sub-threshold PTSD (operationalized as a total score of >33 on the PTSD Checklist Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5),
- Report deficits in Emotion Regulation (operationalized as a score of 0.5 SD above published means on the DERS).
Who cannot join
- FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale [C-SSRS]), will be initially excluded until a secondary risk and safety assessment is completed by one of the Texas licensed study psychologists, who will use the VA Comprehensive Suicide Risk Evaluation (CSRE) to determine planning and intentions. Veterans who endorse chronic thoughts of death found among those with PTSD and depression, but who have no suicidal behaviors with intent to act, based on secondary risk assessment, will be included in the study.
- Observable active psychosis (e.g., auditory hallucinations, grandiose delusions),
- Those determined to have problematic substance use (score > 27 on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be referred to substance use dependence programs for concurrent treatment. The PI and Co-Is will collaborate with the substance use dependence program to determine continued participation.
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
Baylor College of Medicine
Houston, Texas, 77030
Kameron Simmons, M.S., 281-410-1792, kameron.simmons@bcm.edu
Deleene Menefee, PhD
About this study
The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.
Read the detailed description
Female Veterans (FVets) face disproportionately high rates of exposure to intimate partner violence (IPV) and military sexual trauma (MST). Studies suggest that a substantial proportion of women with MST and IPV exposure also experience co-occurring brain injury (BI) due to IPV/MST and from non-violent etiologies. Exposure to MST, IPV, and co-occurring BI, coupled with their effects on psychological outcomes, represents a significant health concern to both the military and public, yet there is a lack of effective interventions to treat the cumulative effects of MST, IPV and BI in FVets. The Multifaceted Intervention to Restore Resilience and Overcome Risk (MIRROR) study seeks to overcome this challenge by examining the effectiveness of a multifaceted intervention that combines a web-based emotion regulation (EmReg) intervention (Skills Training in Affective Regulation and Interpersonal Relationships program [webSTAIR]) and a Veteran's Affairs (VA) supported evidence-based practice (EBP), exposure therapy (ExpoTx), for treating post-traumatic stress disorder (PTSD) associated with MST, IPV, and BI in FVets. FVets who screen positive for exposure to MST and/or IPV, have a history of at least one BI, sub-threshold PTSD, and documented emotional dysregulation will be included and randomly assigned to either one of two intervention arms: 1) webSTAIR+ ExpoTx or 2) PsychEd+ ExpoTx. Aim 1 will examine the effectiveness of webSTAIR relative to psychoeducation (PsychEd) on EmReg in FVets with MST and/or IPV and BI. Aim 2 will examine whether improvements in EmReg lead to improved treatment outcomes in FVets. Aim 3 will examine the effectiveness of the interventions in maintaining treatment gains at the 3-month follow-up. The study will include lived experience consultants as research partners and involve a community advisory board (CAB) that includes FVets and key stakeholders.
- Conditions
- Military Sexual Trauma, Intimate Partner Violence, Brain Injury, Post Traumatic Stress Disorder
- Being tested
- webSTAIR, ExpoTx, PsychoEd
- Keywords
- Military Sexual Trauma, Intimate Partner Violence, Female Veterans, Emotion Regulation, Brain Injury, Exposure Therapy
- Medical subject headings
- Military Sexual Trauma, Brain Injuries, Stress Disorders, Post-Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
webSTAIRBehavioural
Also called Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program
Ten web-based modules that are completed independently by participants (~2 modules per week) and receive therapist support via video-telehealth after the completion of every 2 skill modules (1x per week for a total of 5 meetings).
The first five modules review emotional awareness, emotion management, and distress tolerance while the final five modules raise awareness about relationship patterns and provide interpersonal skills training regarding effective assertiveness, interpersonal flexibility, and compassion for self and others.
ExpoTxBehavioural
Also called Exposure therapy
A real-time, present-focused, intervention that does not require participants to relive or focus on past trauma(s), but rather on current social functioning; ie, how they are doing in day-to-day life, and current cognitive and psychological functioning. Therapist will meet individually with the participant for 5 sessions, 60 minutes each conducted virtually. During the 5 sessions, participants will be guided to use in vivo or in the moment ExpoTx to identified fear-based triggers. In each consecutive session, the therapist will engage the Veteran to explore cognitions that interfered with, reinforced, or diminished fear responses. Participants will be asked about their use of coping skills during exposure practice. Intentional participation in exposure for one target at least 30 minutes per day, or until SUDs lower by half. At the end of ExpoTx, the therapist will engage the Veteran in self-determining future goals and offer referrals in the community or at VA for additional support.
PsychoEdOther
Also called Psycho-education
Psycho-education (PsychEd) orientation that provides an overview of PsychEd as a process for learning about mental health symptoms and disease management related to trauma. During PsychEd sessions, therapists will focus on the following 5 areas: 1) Defining trauma and PTSD. 2) Brain Basics and Brain Injury. 3) Understanding the Role of Stress and Its impact on trauma symptoms. 4) The Role of Nutrition and Exercise in Disease Management. 5) Information on other Programs.
| Study group | Role | What they receive |
|---|---|---|
| webSTAIR+ExpoTx | Experimental | Web-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist. Receives: Behavioral: webSTAIR; Behavioral: ExpoTx |
| PsychoEd+ExpoTx | Active comparator | 5 online sessions of psycho-education followed by 5 online sessions of exposure therapy Receives: Behavioral: ExpoTx; Other: PsychoEd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS)
The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses (subscale score 6-30), difficulties engaging in goal directed behavior (subscale score 5-25), impulse control difficulties (subscale score 6-30), lack of emotional awareness (subscale score 6-30), limited access to emotion regulation strategies (subscale score 8-40), and lack of emotional clarity (subscale score 5-25). Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Total Score range from 36-180, with higher scores indicating more difficulty in emotion regulation.
Measured: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
Secondary outcomes (5)
Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), and summed to compute the total scale that ranges from 0 to 80. Higher scores are indicative of greater symptom severity.
Measured: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
Depression and Anxiety Stress Scale (DASS)
Depression Anxiety Stress Scales (DASS-42): A 42-item self-report measure assessing depression, anxiety, and stress. Each scale (14 items) is scored 0-3 per item, with total scores ranging 0-42 per domain. (Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+; Anxiety: Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+; Stress: Normal 0-14, Mild 15-18, Moderate 19-25, Severe 26-33, Extremely Severe 34+). Full scale from 0-126. Higher scores indicate greater severity.
Measured: At week 0, week 5, week 10, and month 3
Inventory of Interpersonal Problems (IIP-32)
A 32-item measure used to screen for difficulties individuals experience in their interactions and relationships with others. The measure yields eight subscales of interpersonal problems including domineering/controlling, vindictive/self-centered, cold/distant, socially inhibited, nonassertive, overly accommodating, self-sacrificing, and intrusive/needy. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely). Subscales ranges are 0-16, with full scale range 0-128, where higher score indicates greater intensity or frequency of interpersonal problems.
Measured: At week 0, week 5, week 10, and month 3
Dysexecutive Questionnaire (DEX)
A 20-item self-report tool used to measure everyday problems associated with executive functioning difficulties. The DEX focuses on four domains: emotional, motivational, behavioral, and cognitive. Items are scored on a five-point scale from 0 (not at all) to 4 (extremely). Higher scores indicating greater reports of dysexecutive problems
Measured: At week 0, week 5, week 10, and month 3
Quality of Life after Brain Injury Overall Scale (QoLABRIOS)
Six item self-report measure of global health related aspects of QoL after BI including physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Full scale from 0-100, higher score indicates better quality of life.
Measured: At week 0, week 5, week 10, and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start12 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Military Sexual TraumaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- The proposed treatment study will employ a phase II RCT to evaluate whether the inclusion of an intervention that specifically targets EmReg (i.e., webSTAIR) prior to engaging in ExpoTx (webSTAIR+ ExpoTx) is more effective in improving outcomes/treatment effectiveness (PTSD symptomology and engagement) in FVets with MST and/or IPV and BI exposure. This treatment combination, (webSTAIR+ ExpoTx), will be compared to the standard EBP combination (PsychEd+ExpoTx). Participants will be randomized to one of the two intervention arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Maria Kajankova, Icahn School of Medicine at Mount Sinai
- Investigators
- Maria Kajankova, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988787
- Sponsor's protocol ID
- GCO 23-1671
- Other IDs
- HT94252410478
- Acronym
- MIRROR
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared, however, as required in study grant agreement, study team will upload a limited dataset to FITBIR.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Intervention to Restore Resilience and Overcome Risk
- ClinicalTrials.gov ID
- NCT06988787
- Acronym / sponsor ID
- MIRROR / GCO 23-1671
- Conditions
- Military Sexual Trauma, Intimate Partner Violence, Brain Injury, Post Traumatic Stress Disorder
- Keywords
- Military Sexual Trauma, Intimate Partner Violence, Female Veterans, Emotion Regulation, Brain Injury, Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 May 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.
The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.
Detailed description
Female Veterans (FVets) face disproportionately high rates of exposure to intimate partner violence (IPV) and military sexual trauma (MST). Studies suggest that a substantial proportion of women with MST and IPV exposure also experience co-occurring brain injury (BI) due to IPV/MST and from non-violent etiologies. Exposure to MST, IPV, and co-occurring BI, coupled with their effects on psychological outcomes, represents a significant health concern to both the military and public, yet there is a lack of effective interventions to treat the cumulative effects of MST, IPV and BI in FVets. The Multifaceted Intervention to Restore Resilience and Overcome Risk (MIRROR) study seeks to overcome this challenge by examining the effectiveness of a multifaceted intervention that combines a web-based emotion regulation (EmReg) intervention (Skills Training in Affective Regulation and Interpersonal Relationships program [webSTAIR]) and a Veteran's Affairs (VA) supported evidence-based practice (EBP), exposure therapy (ExpoTx), for treating post-traumatic stress disorder (PTSD) associated with MST, IPV, and BI in FVets. FVets who screen positive for exposure to MST and/or IPV, have a history of at least one BI, sub-threshold PTSD, and documented emotional dysregulation will be included and randomly assigned to either one of two intervention arms: 1) webSTAIR+ ExpoTx or 2) PsychEd+ ExpoTx. Aim 1 will examine the effectiveness of webSTAIR relative to psychoeducation (PsychEd) on EmReg in FVets with MST and/or IPV and BI. Aim 2 will examine whether improvements in EmReg lead to improved treatment outcomes in FVets. Aim 3 will examine the effectiveness of the interventions in maintaining treatment gains at the 3-month follow-up. The study will include lived experience consultants as research partners and involve a community advisory board (CAB) that includes FVets and key stakeholders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed treatment study will employ a phase II RCT to evaluate whether the inclusion of an intervention that specifically targets EmReg (i.e., webSTAIR) prior to engaging in ExpoTx (webSTAIR+ ExpoTx) is more effective in improving outcomes/treatment effectiveness (PTSD symptomology and engagement) in FVets with MST and/or IPV and BI exposure. This treatment combination, (webSTAIR+ ExpoTx), will be compared to the standard EBP combination (PsychEd+ExpoTx). Participants will be randomized to one of the two intervention arms.
| Arm | Type | Receives |
|---|---|---|
| webSTAIR+ExpoTx | Experimental | Behavioral: webSTAIR, Behavioral: ExpoTxWeb-based technology "webSTAIR" (Web-Based Skills Training in Affective Regulation and Interpersonal Relationships Program) will be used to guide Female Veterans (FVets) through each of the 10 webSTAIR skill modules for 5-weeks followed by 5 weeks of standard, patient-centered, exposure therapy (ExpoTx) delivered by a therapist. |
| PsychoEd+ExpoTx | Active comparator | Behavioral: ExpoTx, Other: PsychoEd5 online sessions of psycho-education followed by 5 online sessions of exposure therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to consent as determined by UBACC, are English-speaking FVets who are 18+ years old
- Screen positive for exposure to IPV and/or MST using the VA Intimate Partner Violence Assistance Program (VA IPVAP) and MST Screening Protocol,
- Have a history of at least one BI assessed using the BISQ+IPV,
- Sub-threshold PTSD (operationalized as a total score of >33 on the PTSD Checklist Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5),
- Report deficits in Emotion Regulation (operationalized as a score of 0.5 SD above published means on the DERS).
Key exclusion criteria (3 listed)
- FVets at high risk for suicide (respond yes to items 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale [C-SSRS]), will be initially excluded until a secondary risk and safety assessment is completed by one of the Texas licensed study psychologists, who will use the VA Comprehensive Suicide Risk Evaluation (CSRE) to determine planning and intentions. Veterans who endorse chronic thoughts of death found among those with PTSD and depression, but who have no suicidal behaviors with intent to act, based on secondary risk assessment, will be included in the study.
- Observable active psychosis (e.g., auditory hallucinations, grandiose delusions),
- Those determined to have problematic substance use (score > 27 on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be referred to substance use dependence programs for concurrent treatment. The PI and Co-Is will collaborate with the substance use dependence program to determine continued participation.
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 |
|---|---|---|
| webSTAIRAlso: Web-Based Skills Training in Affective Regulation and Interpersonal Relationships ProgramTen web-based modules that are completed independently by participants (~2 modules per week) and receive therapist support via video-telehealth after the completion of every 2 skill modules (1x per week for a total of 5 meetings). The first five modules review emotional awareness, emotion management, and distress tolerance while the final five modules raise awareness about relationship patterns and provide interpersonal skills training regarding effective assertiveness, interpersonal flexibility, and compassion for self and others. | Behavioural | webSTAIR+ExpoTx |
| ExpoTxAlso: Exposure therapyA real-time, present-focused, intervention that does not require participants to relive or focus on past trauma(s), but rather on current social functioning; ie, how they are doing in day-to-day life, and current cognitive and psychological functioning. Therapist will meet individually with the participant for 5 sessions, 60 minutes each conducted virtually. During the 5 sessions, participants will be guided to use in vivo or in the moment ExpoTx to identified fear-based triggers. In each consecutive session, the therapist will engage the Veteran to explore cognitions that interfered with, reinforced, or diminished fear responses. Participants will be asked about their use of coping skills during exposure practice. Intentional participation in exposure for one target at least 30 minutes per day, or until SUDs lower by half. At the end of ExpoTx, the therapist will engage the Veteran in self-determining future goals and offer referrals in the community or at VA for additional support. | Behavioural | PsychoEd+ExpoTx, webSTAIR+ExpoTx |
| PsychoEdAlso: Psycho-educationPsycho-education (PsychEd) orientation that provides an overview of PsychEd as a process for learning about mental health symptoms and disease management related to trauma. During PsychEd sessions, therapists will focus on the following 5 areas: 1) Defining trauma and PTSD. 2) Brain Basics and Brain Injury. 3) Understanding the Role of Stress and Its impact on trauma symptoms. 4) The Role of Nutrition and Exercise in Disease Management. 5) Information on other Programs. | Other | PsychoEd+ExpoTx |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS)
Time frame: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses (subscale score 6-30), difficulties engaging in goal directed behavior (subscale score 5-25), impulse control difficulties (subscale score 6-30), lack of emotional awareness (subscale score 6-30), limited access to emotion regulation strategies (subscale score 8-40), and lack of emotional clarity (subscale score 5-25). Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Total Score range from 36-180, with higher scores indicating more difficulty in emotion regulation.
5 secondary outcomes
Post-Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
Time frame: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3
Depression and Anxiety Stress Scale (DASS)
Time frame: At week 0, week 5, week 10, and month 3
Inventory of Interpersonal Problems (IIP-32)
Time frame: At week 0, week 5, week 10, and month 3
Dysexecutive Questionnaire (DEX)
Time frame: At week 0, week 5, week 10, and month 3
Quality of Life after Brain Injury Overall Scale (QoLABRIOS)
Time frame: At week 0, week 5, week 10, and month 3
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 21 Sep 2026.
- Individual participant dataSharing planned: No. Data will not be shared, however, as required in study grant agreement, study team will upload a limited dataset to FITBIR.
Related trials for Military Sexual Trauma
RecruitingPhase 4
Adaptions and Resiliency to Multi-Stressor OpeRations
Musculoskeletal Injury, Hypogonadism
Not yet recruiting
Recovery-oriented Group Therapy for Veteran Men With Military Sexual Trauma
Sexual Trauma
Recruiting
A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
PTSD
Active, not recruiting
Efficacy of Virtual Warrior Renew Therapy for Veterans Who Experienced Military Sexual Trauma
Military Sexual Trauma (MST), Post Traumatic Stress Disorder
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.
Maria Kajankova, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing webSTAIR, ExpoTx and PsychoEd in people with Military Sexual Trauma and Intimate Partner Violence, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 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 21 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?
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 Maria Kajankova, PhD (212-241-3379, maria.kajankova@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS) (time frame: At week 0, week 2.5, week 5, week 7.5, week 10, and month 3). 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 21 Sep 2026.