Community-based Implementation of Online EmReg

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933629
• Other study ID #: STUDY-22-01380
• Secondary ID: 90DPTB0028-01-00
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: August 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Emily Blunt, BA
• Phone: 212-241-0818
• Email: emily.blunt[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 15 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Exclusion Criteria:

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Emotion Regulation
• Traumatic Brain Injury

Intervention

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
• Consultation Sessions
3 months of bi-weekly consultation sessions

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 15 months
Primary	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.	Post-3 hour EmReg training workshop
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	Number of EmReg groups scheduled and completed	The number of EmReg groups scheduled and completed by the clinician participants	Up to 15 months
Secondary	Time between initial uptake and completion	The time between completion of training and initial uptake will be tracked.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months
Secondary	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.	Up to 15 months