Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192227
• Other study ID #: E-1076-19
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: June 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Partner Caregiver
• Traumatic Brain Injury

Intervention

Behavioral:
• EnHAncing 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Rehabilitation Hospital of Indiana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change on Behavioral Activation Scale (BAS)	The BAS measures responsiveness to goals, fun, and rewarding stimuli.	6 weeks (between pre- and post testing)