RECRUITING

Community-based Implementation of Online EmReg

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-18
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05933629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Licensed psychologist, social worker, or mental health counselor.
  2. * Training and experience in CBT, the framework for EmReg.
  3. * Experience working with people with TBI.
  4. * Experience providing group treatment.
  5. * A computer and internet to conduct group treatment via telehealth.
  6. * Actively treating ≥3 patients with TBI who are appropriate for EmReg (have emotion regulation difficulties based on clinician assessment).
  7. * Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
  8. * Not previously trained in EmReg.
  9. * Proficient in English.
  1. * Not willing to conduct group treatment via telehealth.
  2. * Non-English speaking.

Contacts and Locations

Study Contact

Emily Blunt, BA
CONTACT
212-241-0818
emily.blunt@mountsinai.org
Annell Ovalles, MPH
CONTACT
212-241-4706
annell.ovalles@mountsinai.org

Principal Investigator

Maria Kajankova, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Maria Kajankova, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Emotion Regulation