Stress Disorders, Post-TraumaticMERANCT04793776
Manage Emotions to Reduce Aggression (MERA)
A study testing Manage Emotions to Reduce Aggression and Present Centered Psychotherapy in people with Stress Disorders, Post-Traumatic and Aggression, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with PTSD report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Aggression, Emotion Regulation
- What is being tested?
- Manage Emotions to Reduce Aggression and Present Centered Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2022to 30 Dec 2026
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female Veterans who deployed to combat zones since 9/11
- Currently meets criteria for full or subthreshold post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with PTSD report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5
- Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by the Overt Aggression Scale
- Impulsive aggression is his/her primary form of aggression, determined by the Impulsive Premeditated Aggression Scale
- Each Veteran must allow an independent aggression rater (live-in partner, family member, or roommate above 18 years of age) verify the number of aggressive acts, using the Overt Aggression Scale
- Agreement not to change psychotropic medications through the duration of the study
Who cannot join
- Currently suicidal with intent of self-harm in the last week
- Currently homicidal with plans to hurt a specific person
- Unable to complete self-report measures
- Meets diagnostic criteria for bipolar disorder or psychotic disorder
- Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Veterans receiving general mental health services or engaging in usual care will be allowed to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Manage Emotions to Reduce Aggression - MERA: A Brief Aggression Treatment for Veterans With PTSD Symptoms
Post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with PTSD report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.
Read the detailed description
Aggression can have devastating interpersonal and societal consequences, including incarceration, family violence, disruption of treatment-facilitating factors, and death. About 50% of Veterans with full and subthreshold posttraumatic stress disorder (PTSD) reported engaging in aggression after returning from deployment. This level of aggression is higher than Veterans without PTSD5 and civilians with PTSD. Current psychotherapy options to reduce aggression include present centered therapies (PCTs), anger management, and evidence based psychotherapies (EBP) for PTSD. Anger management reduces aggression in civilian samples with small to moderate effect sizes. However, few anger management treatment studies have examined Veterans with PTSD and measured acts of aggression. Consistently, VA clinicians also provide PCTs and EBP for PTSD. It is unknown how effectively PCTs reduce aggression. Unfortunately, even with gold standard EBP for PTSD Veterans only experience small to moderate reductions in aggression. While any decline is an improvement, these treatments leave room for novel methods to help Veterans reduce aggression.
Emotion regulation ability may be a key to reducing aggression. The team revealed that among Veterans with PTSD and aggression, impulsive aggression (emotionally charged, reactive, and uncontrolled) is more common than premeditated aggression (deliberate, instrumental, and planned). Emotion dysregulation, or the inability to detect emotions, accept emotions, and/or engage in content-appropriate regulation, is related to impulsive aggression and to PTSD severity. The investigators demonstrated that emotion dysregulation fully mediated the relationship between PTSD and impulsive aggression in Veterans.
Increasing emotion regulation ability of many emotions is an innovative method to reduce aggression. Full-length treatments that incorporate emotion regulation training (8-12 sessions) have augmented EBP for PTSD and improved Veterans' emotion regulation skills. However, a brief format is needed for returning Veterans. Eight weeks of treatment, particularly when offered prior to EBP, is an unfeasible commitment for many Veterans who are reintegrating into their communities. Additionally, most drop outs from EBP for PTSD occur prior to session three making the initial sessions a critical time for skill development. Finally, Veterans have experienced wait times to receive treatment due to the growing population of returning Veterans. To address these challenges, the team developed a 3-session emotion regulation treatment, called Manage Emotions to Reduce Aggression (MERA). Male combat Veterans who completed MERA in an open trial (N=20) endorsed the brief model, utilized the skills, and found the treatment helpful at the 4-week follow up. MERA had a low dropout rate of 8% from active treatment. MERA completers demonstrated a medium to large pre- to post-treatment reduction in frequency of aggression (Cohen's d = 0.73).
The goal of the proposed study is to conduct a 2-site randomized clinical trial (RCT) to test if MERA is efficacious at reducing aggression and emotion dysregulation compared to 3 sessions of PCT, which is often the standard of care for Veterans with aggression.
Aim 1: Determine if MERA results in reductions in frequency of impulsive aggression compared to PCT in Veterans (N = 204) with subthreshold or full PTSD who have deployed for combat operations since 9/11.
Hypothesis 1: MERA will demonstrate statistically significant greater reductions in frequency of aggression (measured by the Overt Aggression Scale) relative to PCT at the 2-month posttreatment assessment.
Aim 2: Examine if MERA reduces emotion dysregulation relative to PCT. Hypothesis 2: MERA will demonstrate statistically significant greater reductions in emotion dysregulation (measured by Difficulties in Emotion Regulation Scale) relative to PCT at the posttreatment assessment.
Exploratory Aim. Veterans who learn to regulate their emotions rather than avoid them may be more likely to engage in EBP for PTSD. The investigators will examine if Veterans who complete MERA have higher rates of EBP initiation compared to Veterans who complete PCT. Exploratory Hypothesis: Veterans who complete MERA will have statistically significant higher rates of EBP initiation than Veterans who complete PCT.
If the hypotheses are supported, the VA will have a brief treatment that can help Veterans manage their aggression by directly targeting emotion dysregulation. MERA may also be applicable to Veterans with emotion dysregulation and other psychological disorders.
- Being tested
- Manage Emotions to Reduce Aggression, Present Centered Psychotherapy
- Keywords
- Stress Disorders, Post-Traumatic, Aggression, Emotion Regulation, Veterans, Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Aggression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manage Emotions to Reduce AggressionBehavioural
Also called MERA
MERA begins with education about the adaptive nature of emotions, how childhood and military experiences can influence emotion regulation, and how combat requires different emotion regulation strategies than most civilian environments. MERA use modeling and practice with feedback to teach cognitive-behavioral and acceptance-based emotion regulation skills.
Present Centered PsychotherapyBehavioural
Also called PCT
PCT will serve as the comparison group. PCT assists Veterans in understanding and coping with current difficulties, such as aggression, but does not provide systematic training in emotion regulation skills.
| Study group | Role | What they receive |
|---|---|---|
| Manage Emotions to Reduce Aggression (MERA) | Experimental | MERA is 3 individual 90-minute sessions delivered over 3 weeks. Receives: Behavioral: Manage Emotions to Reduce Aggression |
| Present Centered Psychotherapy (PCT) | Active comparator | PCT delivered in 3 individual 90-minute sessions over 3 weeks. Receives: Behavioral: Present Centered Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overt Aggression Scale (OAS)
Overt Aggression Scale is a 17-item self-report measure that assesses frequency of verbal and physical aggression against self, other, and objects and while driving over the past week. Veterans' self-reported aggressive acts will be summed to create an OAA total score. Minimum score = 0; there is no maximum score as Veterans can report as many episodes of aggression as they engage in.
Measured: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Secondary outcomes (1)
Change in Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (16) is a 36-item self-report measure with 6 different emotion-dysregulation factors: nonacceptance of emotional responses, difficulties engaging in goal directed behaviors, impulse-control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Scoring is based on how well the item describes the individual in the past month, from 1 (almost never) to 5 (almost always). Minimum score = 36; Maximum score = 180. Higher scores represent more emotion dysregulation.
Measured: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start3 Jan 2022
- Primary completion1 Oct 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- This randomized clinical trial (RCT) is designed to examine if a brief emotion regulation treatment, MERA, is efficacious at reducing aggression compared to present centered therapy (PCT) in Veterans with full or subthreshold PTSD. The investigators will use a parallel group RCT design, a 1:1 allocation ratio, and a superiority (MERA \> PCT) framework. The study will follow the SPIRIT 2013 Checklist that is recommended for RCT protocols.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, University of South Florida, VA Boston Healthcare System, University of Houston, Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Shannon R. Miles, PhD, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793776
- Sponsor's protocol ID
- MHBP-007-20S
- Other IDs
- 1I01CX002135-01A1, CX002135
- Acronym
- MERA
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying publications resulting from the proposed research will be shared outside VA in electronic format through the mechanism(s) indicated below. * A De-identified, Anonymized Dataset will be created and shared. * Final de-identified data sets underlying publications resulting from the proposed research will be available outside the VA using the following mechanism, electronic format through e-mail upon request, after results are published. Data sets will also be available through collaborators and other investigators upon request prior to publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manage Emotions to Reduce Aggression - MERA: A Brief Aggression Treatment for Veterans With PTSD Symptoms
- ClinicalTrials.gov ID
- NCT04793776
- Acronym / sponsor ID
- MERA / MHBP-007-20S
- Keywords
- Stress Disorders, Post-Traumatic, Aggression, Emotion Regulation, Veterans, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, University of South Florida, VA Boston Healthcare System, University of Houston, Texas A&M University
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Mar 2021 (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.
Post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with PTSD report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.
Detailed description
Aggression can have devastating interpersonal and societal consequences, including incarceration, family violence, disruption of treatment-facilitating factors, and death. About 50% of Veterans with full and subthreshold posttraumatic stress disorder (PTSD) reported engaging in aggression after returning from deployment. This level of aggression is higher than Veterans without PTSD5 and civilians with PTSD. Current psychotherapy options to reduce aggression include present centered therapies (PCTs), anger management, and evidence based psychotherapies (EBP) for PTSD. Anger management reduces aggression in civilian samples with small to moderate effect sizes. However, few anger management treatment studies have examined Veterans with PTSD and measured acts of aggression. Consistently, VA clinicians also provide PCTs and EBP for PTSD. It is unknown how effectively PCTs reduce aggression. Unfortunately, even with gold standard EBP for PTSD Veterans only experience small to moderate reductions in aggression. While any decline is an improvement, these treatments leave room for novel methods to help Veterans reduce aggression.
Emotion regulation ability may be a key to reducing aggression. The team revealed that among Veterans with PTSD and aggression, impulsive aggression (emotionally charged, reactive, and uncontrolled) is more common than premeditated aggression (deliberate, instrumental, and planned). Emotion dysregulation, or the inability to detect emotions, accept emotions, and/or engage in content-appropriate regulation, is related to impulsive aggression and to PTSD severity. The investigators demonstrated that emotion dysregulation fully mediated the relationship between PTSD and impulsive aggression in Veterans.
Increasing emotion regulation ability of many emotions is an innovative method to reduce aggression. Full-length treatments that incorporate emotion regulation training (8-12 sessions) have augmented EBP for PTSD and improved Veterans' emotion regulation skills. However, a brief format is needed for returning Veterans. Eight weeks of treatment, particularly when offered prior to EBP, is an unfeasible commitment for many Veterans who are reintegrating into their communities. Additionally, most drop outs from EBP for PTSD occur prior to session three making the initial sessions a critical time for skill development. Finally, Veterans have experienced wait times to receive treatment due to the growing population of returning Veterans. To address these challenges, the team developed a 3-session emotion regulation treatment, called Manage Emotions to Reduce Aggression (MERA). Male combat Veterans who completed MERA in an open trial (N=20) endorsed the brief model, utilized the skills, and found the treatment helpful at the 4-week follow up. MERA had a low dropout rate of 8% from active treatment. MERA completers demonstrated a medium to large pre- to post-treatment reduction in frequency of aggression (Cohen's d = 0.73).
The goal of the proposed study is to conduct a 2-site randomized clinical trial (RCT) to test if MERA is efficacious at reducing aggression and emotion dysregulation compared to 3 sessions of PCT, which is often the standard of care for Veterans with aggression.
Aim 1: Determine if MERA results in reductions in frequency of impulsive aggression compared to PCT in Veterans (N = 204) with subthreshold or full PTSD who have deployed for combat operations since 9/11.
Hypothesis 1: MERA will demonstrate statistically significant greater reductions in frequency of aggression (measured by the Overt Aggression Scale) relative to PCT at the 2-month posttreatment assessment.
Aim 2: Examine if MERA reduces emotion dysregulation relative to PCT. Hypothesis 2: MERA will demonstrate statistically significant greater reductions in emotion dysregulation (measured by Difficulties in Emotion Regulation Scale) relative to PCT at the posttreatment assessment.
Exploratory Aim. Veterans who learn to regulate their emotions rather than avoid them may be more likely to engage in EBP for PTSD. The investigators will examine if Veterans who complete MERA have higher rates of EBP initiation compared to Veterans who complete PCT. Exploratory Hypothesis: Veterans who complete MERA will have statistically significant higher rates of EBP initiation than Veterans who complete PCT.
If the hypotheses are supported, the VA will have a brief treatment that can help Veterans manage their aggression by directly targeting emotion dysregulation. MERA may also be applicable to Veterans with emotion dysregulation and other psychological disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized clinical trial (RCT) is designed to examine if a brief emotion regulation treatment, MERA, is efficacious at reducing aggression compared to present centered therapy (PCT) in Veterans with full or subthreshold PTSD. The investigators will use a parallel group RCT design, a 1:1 allocation ratio, and a superiority (MERA > PCT) framework. The study will follow the SPIRIT 2013 Checklist that is recommended for RCT protocols.
| Arm | Type | Receives |
|---|---|---|
| Manage Emotions to Reduce Aggression (MERA) | Experimental | Behavioral: Manage Emotions to Reduce AggressionMERA is 3 individual 90-minute sessions delivered over 3 weeks. |
| Present Centered Psychotherapy (PCT) | Active comparator | Behavioral: Present Centered PsychotherapyPCT delivered in 3 individual 90-minute sessions over 3 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female Veterans who deployed to combat zones since 9/11
- Currently meets criteria for full or subthreshold post-traumatic stress disorder (PTSD) is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with PTSD report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD, determined by the Clinician-Administered PTSD Scale for DSM-5
- Engaged in at least 3 self-reported aggressive acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by the Overt Aggression Scale
- Impulsive aggression is his/her primary form of aggression, determined by the Impulsive Premeditated Aggression Scale
- Each Veteran must allow an independent aggression rater (live-in partner, family member, or roommate above 18 years of age) verify the number of aggressive acts, using the Overt Aggression Scale
Key exclusion criteria (5 listed)
- Currently suicidal with intent of self-harm in the last week
- Currently homicidal with plans to hurt a specific person
- Unable to complete self-report measures
- Meets diagnostic criteria for bipolar disorder or psychotic disorder
- Had a psychotropic medication change within 4 weeks prior to the baseline assessment. Veterans receiving general mental health services or engaging in usual care will be allowed to participate
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 |
|---|---|---|
| Manage Emotions to Reduce AggressionAlso: MERAMERA begins with education about the adaptive nature of emotions, how childhood and military experiences can influence emotion regulation, and how combat requires different emotion regulation strategies than most civilian environments. MERA use modeling and practice with feedback to teach cognitive-behavioral and acceptance-based emotion regulation skills. | Behavioural | Manage Emotions to Reduce Aggression (MERA) |
| Present Centered PsychotherapyAlso: PCTPCT will serve as the comparison group. PCT assists Veterans in understanding and coping with current difficulties, such as aggression, but does not provide systematic training in emotion regulation skills. | Behavioural | Present Centered Psychotherapy (PCT) |
Primary outcome
Change in Overt Aggression Scale (OAS)
Time frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).
Overt Aggression Scale is a 17-item self-report measure that assesses frequency of verbal and physical aggression against self, other, and objects and while driving over the past week. Veterans' self-reported aggressive acts will be summed to create an OAA total score. Minimum score = 0; there is no maximum score as Veterans can report as many episodes of aggression as they engage in.
1 secondary outcome
Change in Difficulties in Emotion Regulation Scale (DERS)
Time frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Final data sets underlying publications resulting from the proposed research will be shared outside VA in electronic format through the mechanism(s) indicated below. * A De-identified, Anonymized Dataset will be created and shared. * Final de-identified data sets underlying publications resulting from the proposed research will be available outside the VA using the following mechanism, electronic format through e-mail upon request, after results are published. Data sets will also be available through collaborators and other investigators upon request prior to publication.
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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.
Shannon R. Miles, PhD principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manage Emotions to Reduce Aggression and Present Centered Psychotherapy in people with Stress Disorders, Post-Traumatic and Aggression, run by VA Office of Research and Development at 2 sites 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 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 in Overt Aggression Scale (OAS) (time frame: Treatment group differences in change from Session 1 to posttreatment assessment (duration of 11 weeks).). 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 Oct 2026.