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Completed

NCT Number: NCT04192227

Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Partner Caregiver Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital of Indiana, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EnHAncing BehavIors through wellness TreatmentS (HABITS)

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Rehabilitation Hospital of Indiana

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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