Traumatic Brain Injury
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).
Interventions
BEHAVIORALThe Traumatic Brain Injury Family System Intervention.
Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
BEHAVIORALPsycho-educational session at OUH
2.5 hour psycho-educational session for the patient's family members.
Sponsors
Norwegian Extra Foundation for Health and Rehabilitation
The National Association for the Traumatically Injured, Norway
Baerum municipality, Department of Rehablitation, Norway
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should: 1. Be out of post traumatic amnesia for at least one month 2. Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months 3. Have a Ranchos Los Amigos Scale score of at least 8 4. Mini Mental Status Examination score \>23 * Family members: individuals related by blood or marriage/cohabitating with the TBI patient. 1. Belongs to the same household as the individual with TBI and/or in close relation with the patient 2. are between 18-65 years of age.
Exclusion criteria
* TBI survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. Inability to speak and read Norwegian. Families in which there are other members requiring care or who have previously been caregivers for other family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Form 36 Health Survey (SF-36) Mental Component Summary | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Mental health for all study participants |
| Change in Caregiver Burden Scale (CBS) | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Caregiver Burden for the family members |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life after Traumatic Brain Injury (QOLIBRI) | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Quality of Life for the patients |
| Faces IV | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Family dynamics for all study participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resilience Scale for Adults (RSA) | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Resilience for all study participants |
| The Generalized Anxiety Disorder 7 (GAD-7) | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Mental health for all participants |
| The Generalized Self-Efficacy Scale | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Self-efficacy for all participants |
| The TBI Self-Efficacy Scale | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Self-efficacy for the patients |
| Patient Health Questionnaire 9 (PHQ-9) | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | Mental health for all participants |
Countries
Norway
Outcome results
None listed