Menu
Recruiting NCT05933629

Community-based Implementation of Online EmReg

No phase Interventional Traumatic Brain Injury Emotion Regulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Online EmReg, Consultation Sessions.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Emotion Regulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Online EmReg
    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
  • Behavioral Consultation Sessions
    3 months of bi-weekly consultation sessions

Primary outcome measures

  • Provider Self-Efficacy Scale Score [Time frame: Up to 18 months]
  • Performance Evaluation (via Role Plays) [Time frame: Post-3 hour EmReg training workshop]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT05933629 · STUDY-22-01380 · 90DPTB0028-01-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗