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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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
3 months of bi-weekly consultation sessions
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGProvider 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.
Time frame: 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.
Time frame: Post-3 hour EmReg training workshop
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 18 months
Number of EmReg groups scheduled and completed
The number of EmReg groups scheduled and completed by the clinician participants
Time frame: Up to 18 months
Time between initial uptake and completion
The time between completion of training and initial uptake will be tracked.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 18 months
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