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OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury

U

University of Bern

Status and phase

Terminated
Phase 2

Conditions

Brain Injury
Caregivers

Treatments

Other: Waiting-list control group (TAU)
Behavioral: Internet-based supportive coaching OSCAR

Study type

Interventional

Funder types

Other

Identifiers

NCT01112969
1784 -Bern University Hospital
SNF-100014-124574, 2009-2012
OSCAR

Details and patient eligibility

About

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.

Full description

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Family caregiver of an adult with a stroke, cerebral haemorrhage or traumatic brain injury
  • sufficient German language skills
  • at least 3 months after the brain injury
  • access to a computer with internet access
  • minimum age of 18 years
  • informed consent to participate voluntarily in the study

Exclusion Criteria

  • acute suicidal tendency

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Internet-based supportive coaching OSCAR
Experimental group
Description:
Arm 1: Internet-based supportive coaching OSCAR
Treatment:
Behavioral: Internet-based supportive coaching OSCAR
Waiting list control group (treatment as usual, TAU)
Other group
Treatment:
Other: Waiting-list control group (TAU)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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