Clinical trial NCT05933629: Community-based Implementation of Online EmReg
Official title: Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Emotion Regulation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


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.

Primary outcomes:
measure: Provider Self-Efficacy Scale Score
timeFrame: Up to 18 months
measure: Performance Evaluation (via Role Plays)
timeFrame: Post-3 hour EmReg training workshop
Secondary outcomes:
measure: Training Satisfaction Rating Scale
timeFrame: Up to 18 months
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Up to 18 months
measure: Feasibility of Intervention Measure (FIM) Scale
timeFrame: Up to 18 months
measure: Intervention Appropriateness Measure (IAM) Scale
timeFrame: Up to 18 months
measure: Number of EmReg groups scheduled and completed
timeFrame: Up to 18 months
measure: Time between initial uptake and completion
timeFrame: Up to 18 months
measure: Skills Acquisition Quiz for Providers (SAQ-P)
timeFrame: Up to 18 months
measure: Number of participants who receive treatment
timeFrame: Up to 18 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Maria Kajankova, PhD
role: PRINCIPAL_INVESTIGATOR
References: