Clinical trial NCT01112969: OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury
Official title: OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Caregivers
Brain Injury
Keywords: Internet-based supportive coaching
guided self-help
Caregivers
Brain Injury
Caregiver Burden
Coping
Stress
Depression
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Insel Gruppe AG, University Hospital Bern
First posted: 2010-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: German Zarit Burden Interview (G-ZBI)
timeFrame: Baseline
measure: German Zarit Burden Interview (G-ZBI)
timeFrame: 4 months after baseline
measure: German Zarit Burden Interview (G-ZBI)
timeFrame: 8 months after baseline
measure: German Zarit Burden Interview (G-ZBI)
timeFrame: 14 months after baseline (follow-up)
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
measure: Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: Baseline
measure: Perceived Stress Questionnaire (PSQ20)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 4 months after baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 8 months after baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: 14 months after baseline (follow-up)
measure: Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 4 months after baseline
measure: Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 8 months after baseline
measure: Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 14 months after baseline (follow-up)
measure: Perceived Stress Questionnaire (PSQ20)
timeFrame: 4 months after baseline
measure: Perceived Stress Questionnaire (PSQ20)
timeFrame: 8 months after baseline
measure: Perceived Stress Questionnaire (PSQ20)
timeFrame: 14 months after baseline (follow-up)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of clinical psychology and psychotherapy, University of Berne
Study officials:
affiliation: Dep. of Clinical Psychology and Psychotherapy, University of Berne
name: Hansjoerg Znoj, Prof. Dr. phil.
role: STUDY_CHAIR
affiliation: Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
name: Helene Hofer, Dr. phil.
role: STUDY_DIRECTOR
affiliation: University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
name: Martin Grosse Holtforth, Prof. Dr. phil.
role: STUDY_DIRECTOR
affiliation: Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
name: Rene M Mueri, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Dep. of Clinical Psychology and Psychotherapy, University of Berne
name: Eveline Frischknecht, lic. phil.
role: PRINCIPAL_INVESTIGATOR
References: