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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000400
Other study ID # 2016/1215/REK sør-øst C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date May 2020

Study information

Verified date November 2020
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
The Traumatic Brain Injury Family System Intervention.
Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
Psycho-educational session at OUH
2.5 hour psycho-educational session for the patient's family members.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (4)

Lead Sponsor Collaborator
Oslo University Hospital Baerum municipality, Department of Rehablitation, Norway, Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Resilience Scale for Adults (RSA) Resilience for all study participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other The Generalized Self-Efficacy Scale Self-efficacy for all participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other The TBI Self-Efficacy Scale Self-efficacy for the patients Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other Patient Health Questionnaire 9 (PHQ-9) Mental health for all participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other The Generalized Anxiety Disorder 7 (GAD-7) Mental health for all participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Primary Change in Short Form 36 Health Survey (SF-36) Mental Component Summary Mental health for all study participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Primary Change in Caregiver Burden Scale (CBS) Caregiver Burden for the family members Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary Quality of Life after Traumatic Brain Injury (QOLIBRI) Quality of Life for the patients Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary Faces IV Family dynamics for all study participants Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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