Traumatic Brain InjuryNCT05933629
Community-based Implementation of Online EmReg
A study testing Online EmReg and Consultation Sessions in people with Traumatic Brain Injury and Emotion Regulation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Emotion Regulation
- What is being tested?
- Online EmReg and Consultation Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed psychologist, social worker, or mental health counselor.
- Training and experience in CBT, the framework for EmReg.
- Experience working with people with TBI.
- Experience providing group treatment.
- A computer and internet to conduct group treatment via telehealth.
- Actively treating ≥3 patients with TBI who are appropriate for EmReg (have emotion regulation difficulties based on clinician assessment).
Show all 9Show fewer
- Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
- Not previously trained in EmReg.
- Proficient in English.
Who cannot join
- Not willing to conduct group treatment via telehealth.
- Non-English speaking.
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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Maria Kajankova, PhD, 212-241-3379, maria.kajankova@mountsinai.org
Maria Kajankova
About this study
Official title: Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury
This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 18 months.
- Conditions
- Traumatic Brain Injury, Emotion Regulation
- Being tested
- Online EmReg, Consultation Sessions
- Medical subject headings
- Brain Injuries, Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online EmRegBehavioural
A Web-based group intervention to improve emotion regulation in individuals with traumatic brain injury (TBI). Online EmReg is a 3-hour on-demand training workshop
Consultation SessionsBehavioural
3 months of bi-weekly consultation sessions
| Study group | Role | What they receive |
|---|---|---|
| Standard Training | Active comparator | Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice. Receives: Behavioral: Online EmReg |
| Extended Training | Experimental | Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training. Receives: Behavioral: Online EmReg; Behavioral: Consultation Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Self-Efficacy Scale Score
A 7-item Likert Scale (not at all confident (1) to fully confident (7)) adapted for use with EmReg to assess provider confidence in delivering core components of the Online EmReg intervention. Total scores range from 26 to 182. Higher values indicate a higher level of self-efficacy. Used in the literature to reliably predict implementation of evidence-based interventions.
Measured: Up to 18 months
Performance Evaluation (via Role Plays)
Assessed using a structured role play of EmReg groups in a simulated clinical setting. These role plays will be recorded and rated by a blinded evaluator. The evaluator will indicate the degrees to which the session goals were accomplished using a 15-item checklist. Each item will be rated a 0 (not introduced or covered), 1 (attempted/partially achieved), 2 (fully covered/achieved), or N/A (not applicable/relevant to session #). Participants can receive a total score of 0 to 30 on their performance-based role play. Higher values indicate higher achievement.
Measured: Post-3 hour EmReg training workshop
Secondary outcomes (9)
Training Satisfaction Rating Scale
Satisfaction with training will be assessed using the Training Satisfaction Rating Scale, a 12-item, 5-point Likert scale (higher scores = higher satisfaction). Total scores range from 12 to 60. Training engagement and consultation engagement (extended group only) will be tracked by study team.
Measured: Up to 18 months
Acceptability of Intervention Measure (AIM)
Provider's satisfaction with the intervention will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater acceptability.
Measured: Up to 18 months
Feasibility of Intervention Measure (FIM) Scale
Feasibility of the intervention will be assessed using the Feasibility of Intervention Measure (FIM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater feasibility.
Measured: Up to 18 months
Intervention Appropriateness Measure (IAM) Scale
Appropriateness of the intervention will be assessed using the Intervention Appropriateness Measure (IAM), a 4-item, 5-point Likert scale. Total scores can range from 4 to 20 with higher scores indicating greater intervention appropriateness.
Measured: Up to 18 months
Number of EmReg groups scheduled and completed
The number of EmReg groups scheduled and completed by the clinician participants
Measured: Up to 18 months
Time between initial uptake and completion
The time between completion of training and initial uptake will be tracked.
Measured: Up to 18 months
Skills Acquisition Quiz for Providers (SAQ-P)
Clinician participants will be given a 25-item multiple-choice test of knowledge of Online EmReg training content. Correct answers are coded as 1 and incorrect answers are coded as 0. Scores range from 0-25 with higher scores indicating greater knowledge of the intervention.
Measured: Up to 18 months
Number of participants who receive treatment
Clinician participants will be asked to track the number of patients who receive treatment out of those who appear eligible.
Measured: Up to 18 months
Difficulties in Emotion Regulation Scale (DERS)
A 36-item questionnaire assessing capacity for emotion regulation. Each item is scored on a 5-point scale. Total scores range from 80 to 136. Out of the 36 items, 11 are reverse scored. Higher scores suggest greater problems with emotion regulation.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start18 Jul 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- 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
- NCT05933629
- Sponsor's protocol ID
- STUDY-22-01380
- Other IDs
- 90DPTB0028-01-00
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to share individual participant data. Results will be published by the investigators in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05933629
- Acronym / sponsor ID
- STUDY-22-01380
- Conditions
- Traumatic Brain Injury, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Jul 2023 (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.
This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Training | Active comparator | Behavioral: Online EmRegParticipants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice. |
| Extended Training | Experimental | Behavioral: Online EmReg, Behavioral: Consultation SessionsParticipants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Licensed psychologist, social worker, or mental health counselor.
- Training and experience in CBT, the framework for EmReg.
- Experience working with people with TBI.
- Experience providing group treatment.
- A computer and internet to conduct group treatment via telehealth.
Key exclusion criteria (2 listed)
- Not willing to conduct group treatment via telehealth.
- Non-English speaking.
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 |
|---|---|---|
| Online EmRegA Web-based group intervention to improve emotion regulation in individuals with traumatic brain injury (TBI). Online EmReg is a 3-hour on-demand training workshop | Behavioural | Extended Training, Standard Training |
| Consultation Sessions3 months of bi-weekly consultation sessions | Behavioural | Extended Training |
Primary outcome
Provider Self-Efficacy Scale Score
Time frame: Up to 18 months
A 7-item Likert Scale (not at all confident (1) to fully confident (7)) adapted for use with EmReg to assess provider confidence in delivering core components of the Online EmReg intervention. Total scores range from 26 to 182. Higher values indicate a higher level of self-efficacy. Used in the literature to reliably predict implementation of evidence-based interventions.
Performance Evaluation (via Role Plays)
Time frame: Post-3 hour EmReg training workshop
Assessed using a structured role play of EmReg groups in a simulated clinical setting. These role plays will be recorded and rated by a blinded evaluator. The evaluator will indicate the degrees to which the session goals were accomplished using a 15-item checklist. Each item will be rated a 0 (not introduced or covered), 1 (attempted/partially achieved), 2 (fully covered/achieved), or N/A (not applicable/relevant to session #). Participants can receive a total score of 0 to 30 on their performance-based role play. Higher values indicate higher achievement.
9 secondary outcomes
Training Satisfaction Rating Scale
Time frame: Up to 18 months
Acceptability of Intervention Measure (AIM)
Time frame: Up to 18 months
Feasibility of Intervention Measure (FIM) Scale
Time frame: Up to 18 months
Intervention Appropriateness Measure (IAM) Scale
Time frame: Up to 18 months
Number of EmReg groups scheduled and completed
Time frame: Up to 18 months
Time between initial uptake and completion
Time frame: Up to 18 months
Skills Acquisition Quiz for Providers (SAQ-P)
Time frame: Up to 18 months
Number of participants who receive treatment
Time frame: Up to 18 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 18 months
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 16 Jul 2026.
- Individual participant dataSharing planned: No. Currently, there is no plan to share individual participant data. Results will be published by the investigators in academic journals.
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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.
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 Online EmReg and Consultation Sessions in people with Traumatic Brain Injury and Emotion Regulation, 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 9 inclusion and 2 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 16 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. 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 Emily Blunt, BA (212-241-0818, emily.blunt@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Self-Efficacy Scale Score (time frame: Up to 18 months). The study lists 2 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 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.