Comparison of Two Group Wellness Interventions in TBI Partner Caregivers

Kessler Foundation

Status: Completed

Conditions: Traumatic Brain Injury; Partner Caregiver

Treatments: Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04192227

E-1076-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Wellness Group 1

Experimental group

Description:

Administered by wellness facilitator and co-facilitator.

Treatment:

Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)

Wellness Group 2

Active Comparator group

Description:

Administered by wellness facilitator and co-facilitator.

Treatment:

Behavioral: EnHAncing BehavIors through wellness TreatmentS (HABITS)