Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05933629

Community-based Implementation of Online EmReg

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Traumatic Brain Injury Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Emotion Regulation Emotional Regulation Nervous System Diseases Self-Control Social Behavior Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Maria Kajankova

PRINCIPAL_INVESTIGATOR

Maria Kajankova, PhD

CONTACT

[email protected]

212-241-3379

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
  • Not previously trained in EmReg.
  • Proficient in English.

Exclusion criteria

  • Not willing to conduct group treatment via telehealth.
  • Non-English speaking.

Treatment and study plan

Online EmReg

Behavioral

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 Sessions

Behavioral

3 months of bi-weekly consultation sessions

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Training Satisfaction Rating Scale

    Time frame: Up to 18 months

    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.

  2. Acceptability of Intervention Measure (AIM)

    Time frame: Up to 18 months

    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.

  3. Feasibility of Intervention Measure (FIM) Scale

    Time frame: Up to 18 months

    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.

  4. Intervention Appropriateness Measure (IAM) Scale

    Time frame: Up to 18 months

    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.

  5. Number of EmReg groups scheduled and completed

    Time frame: Up to 18 months

    The number of EmReg groups scheduled and completed by the clinician participants

  6. Time between initial uptake and completion

    Time frame: Up to 18 months

    The time between completion of training and initial uptake will be tracked.

  7. Skills Acquisition Quiz for Providers (SAQ-P)

    Time frame: Up to 18 months

    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.

  8. Number of participants who receive treatment

    Time frame: Up to 18 months

    Clinician participants will be asked to track the number of patients who receive treatment out of those who appear eligible.

  9. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Up to 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annell Ovalles, MPH

CONTACT

[email protected]

212-241-4706

Emily Blunt, BA

CONTACT

[email protected]

212-241-0818

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.