Family Intervention Following Traumatic Injury (FITS)

Rigshospitalet

Status: Completed

Conditions: Spinal Cord Injuries; Acquired Brain Injury

Treatments: Behavioral: FITS; Behavioral: Group session psycho-education

Study type: Interventional

Funder types: Other

Identifiers

NCT03814876

2018_0004

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.

Enrollment: 157 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acquired brain injury or spinal cord injury
• Talk and read Danish
• Minimum 6 months to 2 years since discharge
• Family members must be actively involved in the patient's rehabilitation

Exclusion criteria

• Severe aphasia
• Families, where other family members require a substantial amount of care
• Prior psychiatric or neurological disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 4 patient groups

SCI intervention

Experimental group

Description:

Spinal cord injury intervention group

Treatment:

Behavioral: FITS

SCI control

Active Comparator group

Description:

Spinal cord injury control

Treatment:

Behavioral: Group session psycho-education

TBI intervention

Experimental group

Description:

Traumatic brain injury intervention group

Treatment:

Behavioral: FITS

TBI control

Active Comparator group

Description:

Traumatic brain injury control group

Treatment:

Behavioral: Group session psycho-education