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Community-based Implementation of Online EmReg

Primary Purpose

Traumatic Brain Injury, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online EmReg
Consultation Sessions
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Training

Extended Training

Arm Description

Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice.

Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Number of EmReg groups scheduled and completed
The number of EmReg groups scheduled and completed by the clinician participants
Time between initial uptake and completion
The time between completion of training and initial uptake will be tracked.
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.
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.
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.

Full Information

First Posted
June 27, 2023
Last Updated
August 2, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05933629
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 15 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Emotion Regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Training
Arm Type
Active Comparator
Arm Description
Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice.
Arm Title
Extended Training
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.
Intervention Type
Behavioral
Intervention Name(s)
Online EmReg
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Consultation Sessions
Intervention Description
3 months of bi-weekly consultation sessions
Primary Outcome Measure Information:
Title
Provider Self-Efficacy Scale Score
Description
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 15 months
Title
Performance Evaluation (via Role Plays)
Description
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
Secondary Outcome Measure Information:
Title
Training Satisfaction Rating Scale
Description
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 15 months
Title
Acceptability of Intervention Measure (AIM)
Description
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 15 months
Title
Feasibility of Intervention Measure (FIM) Scale
Description
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 15 months
Title
Intervention Appropriateness Measure (IAM) Scale
Description
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 15 months
Title
Number of EmReg groups scheduled and completed
Description
The number of EmReg groups scheduled and completed by the clinician participants
Time Frame
Up to 15 months
Title
Time between initial uptake and completion
Description
The time between completion of training and initial uptake will be tracked.
Time Frame
Up to 15 months
Title
Skills Acquisition Quiz for Providers (SAQ-P)
Description
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 15 months
Title
Number of participants who receive treatment
Description
Clinician participants will be asked to track the number of patients who receive treatment out of those who appear eligible.
Time Frame
Up to 15 months
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Blunt, BA
Phone
212-241-0818
Email
emily.blunt@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Annell Ovalles, MPH
Phone
212-241-4706
Email
annell.ovalles@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Kajankova, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kajankova, PhD
Phone
212-241-3379
Email
maria.kajankova@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Maria Kajankova

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no plan to share individual participant data. Results will be published by the investigators in academic journals.

Learn more about this trial

Community-based Implementation of Online EmReg

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