Comparison of Two Group Wellness Interventions in TBI Partner Caregivers
1 other identifier
interventional
90
1 country
2
Brief Summary
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
December 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJune 12, 2023
June 1, 2023
2.9 years
December 5, 2019
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change on Behavioral Inhibition Scale (BIS)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
6 weeks (between pre- and post testing)
Change on Behavioral Activation Scale (BAS)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.
6 weeks (between pre- and post testing)
Study Arms (2)
Wellness Group 1
EXPERIMENTALAdministered by wellness facilitator and co-facilitator.
Wellness Group 2
ACTIVE COMPARATORAdministered by wellness facilitator and co-facilitator.
Interventions
Six 75-minute sessions via live video conference wherein participants will receive training in areas of health, wellness and quality of life. Classes will be supplemented with independent homework assignments and discussion on a closed social media forum with peers and facilitators.
Eligibility Criteria
You may qualify if:
- at least 18 years of age.
- read and speak English fluently.
- have been in an intimate relationship with a person with TBI for at least one year prior to their injury.
- partner was discharged from inpatient rehabilitation at least 3 months ago.
- provide care to partner on a daily basis.
- have access to the internet in a private location.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- Rehabilitation Hospital of Indianacollaborator
Study Sites (2)
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254, United States
Kessler Foundation
East Hanover, New Jersey, 07936, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Scientist
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 10, 2019
Study Start
December 15, 2019
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share