Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Not Applicable

Completed

• Conditions: Partner Caregiver; Traumatic Brain Injury
• Interventions: Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)

• Registration Number: NCT04192227
• Lead Sponsor: Kessler Foundation

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Study Start: 2019-12-15
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wellness Group 2	EnHAncing BehavIors through wellness TreatmentS (HABITS)	Administered by wellness facilitator and co-facilitator.
Wellness Group 1	EnHAncing BehavIors through wellness TreatmentS (HABITS)	Administered by wellness facilitator and co-facilitator.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Rehabilitation Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States