Community-based Implementation of Online EmReg

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-18

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Training

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.

Group Type ACTIVE_COMPARATOR

Online EmReg

Intervention Type BEHAVIORAL

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

Extended Training

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.

Group Type EXPERIMENTAL

Online EmReg

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

3 months of bi-weekly consultation sessions

Interventions

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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

Intervention Type BEHAVIORAL

Consultation Sessions

3 months of bi-weekly consultation sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.