Community-based Implementation of Online EmReg
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Not willing to conduct group treatment via telehealth.
Non-English speaking.
Trial design
Design model
Parallel
Treatments tested in this trial
Online EmReg
BehavioralA 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
Behavioral3 months of bi-weekly consultation sessions
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard TrainingActive comparator 1 intervention
Group B: Extended TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 18 months2
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 workshopSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov