Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2022-10-31

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.

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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.

Conditions

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Traumatic Brain Injury Partner Caregiver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Wellness Group 1

Administered by wellness facilitator and co-facilitator.

Group Type EXPERIMENTAL

EnHAncing BehavIors through wellness TreatmentS (HABITS)

Intervention Type 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.

Wellness Group 2

Administered by wellness facilitator and co-facilitator.

Group Type ACTIVE_COMPARATOR

EnHAncing BehavIors through wellness TreatmentS (HABITS)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No