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Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04192227
Enrollment
90
Registered
2019-12-10
Start date
2019-12-15
Completion date
2022-10-31
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partner Caregiver, Traumatic Brain Injury

Keywords

Spouse, Partner, Caregivers, Brain Injuries

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.

Interventions

BEHAVIORALEnHAncing BehavIors through wellness TreatmentS (HABITS)

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.

Sponsors

Rehabilitation Hospital of Indiana
CollaboratorOTHER
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change on Behavioral Inhibition Scale (BIS)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)6 weeks (between pre- and post testing)The BAS measures responsiveness to goals, fun, and rewarding stimuli.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026