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Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Primary Purpose

Traumatic Brain Injury, Partner Caregiver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EnHAncing BehavIors through wellness TreatmentS (HABITS)
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Spouse, Partner, Caregivers, Brain Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation Hospital of Indiana
  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wellness Group 1

Wellness Group 2

Arm Description

Administered by wellness facilitator and co-facilitator.

Administered by wellness facilitator and co-facilitator.

Outcomes

Primary Outcome Measures

Change on Behavioral Inhibition Scale (BIS)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Change on Behavioral Activation Scale (BAS)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
June 9, 2023
Sponsor
Kessler Foundation
Collaborators
Rehabilitation Hospital of Indiana
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1. Study Identification

Unique Protocol Identification Number
NCT04192227
Brief Title
Comparison of Two Group Wellness Interventions in TBI Partner Caregivers
Official Title
Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
Rehabilitation Hospital of Indiana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Partner Caregiver
Keywords
Spouse, Partner, Caregivers, Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wellness Group 1
Arm Type
Experimental
Arm Description
Administered by wellness facilitator and co-facilitator.
Arm Title
Wellness Group 2
Arm Type
Active Comparator
Arm Description
Administered by wellness facilitator and co-facilitator.
Intervention Type
Behavioral
Intervention Name(s)
EnHAncing BehavIors through wellness TreatmentS (HABITS)
Intervention Description
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 Outcome Measure Information:
Title
Change on Behavioral Inhibition Scale (BIS)
Description
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Time Frame
6 weeks (between pre- and post testing)
Title
Change on Behavioral Activation Scale (BAS)
Description
The BAS measures responsiveness to goals, fun, and rewarding stimuli.
Time Frame
6 weeks (between pre- and post testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

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