Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Kessler Foundation
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Change on Behavioral Inhibition Scale (BIS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
A multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). 92 participants will be recruited. Participants are randomly assigned to one of two wellness groups. Each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. Participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. Intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.
Investigators
Denise Krch
Senior Research Scientist
Kessler Foundation
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change on Behavioral Inhibition Scale (BIS)
Time Frame: 6 weeks (between pre- and post testing)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Change on Behavioral Activation Scale (BAS)
Time Frame: 6 weeks (between pre- and post testing)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.