Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury, Partner Caregiver

Intervention / Treatment
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* Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wellness Group 1<br>Administered by wellness facilitator and co-facilitator. | Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)<br>* 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.<br>|
| Active Comparator: Wellness Group 2<br>Administered by wellness facilitator and co-facilitator. | Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spouse, Partner, Caregivers, Brain Injuries