Brain Injury Clinical Trial
Official title:
OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury.
This is an intervention study for informal caregivers of adult patients with an acquired brain injury (stroke, traumatic brain injury or cerebral haemorrhage). It will determine whether an internet-based supportive coaching offers benefits to the caregivers in their own process of coping in the aftermath of a brain injury of a close relative. We expect the internet-based supportive coaching to be more effective in the treatment of emotional distress reactions and caregiver burden than the treatment as usual.
Background
A brain injury (e.g. stroke, traumatic brain injury) occurs all of a sudden and is often
followed by complex neurological and psychological consequences. These consequences do not
only affect the patients with the brain injury as Muriel Lezak already stated in 1988:
"Brain damage is a family affair". Symptoms of depression and anxiety as well as an
increased caregiver burden are common, but there is still a lack in randomized controlled
trials that investigate the efficacy of multicomponent interventions for informal
caregivers. The main aim of the current study is to close this scientific gap with an
innovative method for this special population. OSCAR (the Internet-based supportive
coaching) uses the Internet as a communication- and information brokering medium and is
designed as a "guided-self-help tool" where a qualified therapist individually supports
every participant. The key objective is to investigate the feasibility, acceptance and
efficacy of an Internet-based supportive coaching (OSCAR) for informal caregivers of adult
individuals with an acquired brain injury. It is expected that the Internet-based supportive
coaching (OSCAR) leads to a better coping of emotional distress reactions and caregiver
burden.
Objective
A key objective is to investigate the feasibility, acceptance and efficacy of an
Internet-based supportive coaching (OSCAR) for informal caregivers of adult individuals with
an acquired brain injury.
Methods
To one part, OSCAR is part of a randomized controlled intervention study where a standard
neuropsychological therapy is compared with an integrative neuro-psychotherapy. The
Internet-based supportive coaching (OSCAR) for the caregivers is part of the integrative
neuro-psychotherapy arm.
Additionally a randomized controlled intervention study with a waiting list-control-group
design is realised.
Assessments will be made at baseline, after 4 months (progress), after ending with the
training (termination) and at 6 months post treatment (follow-up).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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