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

This study has suspended participant recruitment.
(Project end after 3 years; prolongation was rejected)
Sponsor:
Collaborators:
Swiss National Science Foundation
University Hospital Inselspital, Berne
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT01112969
First received: April 5, 2010
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Caregivers
Brain Injury
Behavioral: Internet-based supportive coaching OSCAR
Other: Waiting-list control group (TAU)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury.

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • German Zarit Burden Interview (G-ZBI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The German Zarit Burden Interview (G-ZBI) is based on the Zarit Burden Interview (ZBI), the most widely used measure to assess caregiver burden. The 22 Items ask for the strain caregivers perceive (e.g., "Do you feel that your social life has suffered because you are caring for your relative?"). Responses range from 0 (never) to 4 (nearly always), the maximum score being 88. The higher the total score, the heavier the perceived burden.

  • German Zarit Burden Interview (G-ZBI) [ Time Frame: 4 months after baseline ] [ Designated as safety issue: No ]
    The German Zarit Burden Interview (G-ZBI) is based on the Zarit Burden Interview (ZBI), the most widely used measure to assess caregiver burden. The 22 Items ask for the strain caregivers perceive (e.g., "Do you feel that your social life has suffered because you are caring for your relative?"). Responses range from 0 (never) to 4 (nearly always), the maximum score being 88. The higher the total score, the heavier the perceived burden.

  • German Zarit Burden Interview (G-ZBI) [ Time Frame: 8 months after baseline ] [ Designated as safety issue: No ]
    The German Zarit Burden Interview (G-ZBI) is based on the Zarit Burden Interview (ZBI), the most widely used measure to assess caregiver burden. The 22 Items ask for the strain caregivers perceive (e.g., "Do you feel that your social life has suffered because you are caring for your relative?"). Responses range from 0 (never) to 4 (nearly always), the maximum score being 88. The higher the total score, the heavier the perceived burden.

  • German Zarit Burden Interview (G-ZBI) [ Time Frame: 14 months after baseline (follow-up) ] [ Designated as safety issue: No ]
    The German Zarit Burden Interview (G-ZBI) is based on the Zarit Burden Interview (ZBI), the most widely used measure to assess caregiver burden. The 22 Items ask for the strain caregivers perceive (e.g., "Do you feel that your social life has suffered because you are caring for your relative?"). Responses range from 0 (never) to 4 (nearly always), the maximum score being 88. The higher the total score, the heavier the perceived burden.


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI-II) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI-II) is the 1996 revision of the BDI created by Dr. Aaron T. Beck, which is one of the most widely used self-report questionnaires measuring the severity of depression. The 21 multiple-choice items address the severity of 21 typical symptoms of depression over the past two weeks. The higher the total score, the more severe the depression.

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The WHOQOL-BREF self-report questionnaire is the abbreviated 26-item version of the WHOQOL-100. It assesses the perceived quality of life (e.g. "To what extent do you feel your life to be meaningful?"). Quality of life is defined by the WHO as "…individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."

  • Perceived Stress Questionnaire (PSQ20) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.

  • Beck Depression Inventory (BDI-II) [ Time Frame: 4 months after baseline ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI-II) is the 1996 revision of the BDI created by Dr. Aaron T. Beck, which is one of the most widely used self-report questionnaires measuring the severity of depression. The 21 multiple-choice items address the severity of 21 typical symptoms of depression over the past two weeks. The higher the total score, the more severe the depression.

  • Beck Depression Inventory (BDI-II) [ Time Frame: 8 months after baseline ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI-II) is the 1996 revision of the BDI created by Dr. Aaron T. Beck, which is one of the most widely used self-report questionnaires measuring the severity of depression. The 21 multiple-choice items address the severity of 21 typical symptoms of depression over the past two weeks. The higher the total score, the more severe the depression.

  • Beck Depression Inventory (BDI-II) [ Time Frame: 14 months after baseline (follow-up) ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI-II) is the 1996 revision of the BDI created by Dr. Aaron T. Beck, which is one of the most widely used self-report questionnaires measuring the severity of depression. The 21 multiple-choice items address the severity of 21 typical symptoms of depression over the past two weeks. The higher the total score, the more severe the depression.

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 4 months after baseline ] [ Designated as safety issue: No ]
    The WHOQOL-BREF self-report questionnaire is the abbreviated 26-item version of the WHOQOL-100. It assesses the perceived quality of life (e.g. "To what extent do you feel your life to be meaningful?"). Quality of life is defined by the WHO as "…individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 8 months after baseline ] [ Designated as safety issue: No ]
    The WHOQOL-BREF self-report questionnaire is the abbreviated 26-item version of the WHOQOL-100. It assesses the perceived quality of life (e.g. "To what extent do you feel your life to be meaningful?"). Quality of life is defined by the WHO as "…individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 14 months after baseline (follow-up) ] [ Designated as safety issue: No ]
    The WHOQOL-BREF self-report questionnaire is the abbreviated 26-item version of the WHOQOL-100. It assesses the perceived quality of life (e.g. "To what extent do you feel your life to be meaningful?"). Quality of life is defined by the WHO as "…individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."

  • Perceived Stress Questionnaire (PSQ20) [ Time Frame: 4 months after baseline ] [ Designated as safety issue: No ]
    The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.

  • Perceived Stress Questionnaire (PSQ20) [ Time Frame: 8 months after baseline ] [ Designated as safety issue: No ]
    The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.

  • Perceived Stress Questionnaire (PSQ20) [ Time Frame: 14 months after baseline (follow-up) ] [ Designated as safety issue: No ]
    The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.


Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-based supportive coaching OSCAR
Arm 1: Internet-based supportive coaching OSCAR
Behavioral: Internet-based supportive coaching OSCAR
The Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention
Waiting list control group (treatment as usual, TAU) Other: Waiting-list control group (TAU)
Waiting-list control group (treatment as usual, TAU, no specific intervention)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112969

Locations
Switzerland
Dep. of clinical psychology and psychotherapy, University of Berne
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Swiss National Science Foundation
University Hospital Inselspital, Berne
Investigators
Study Chair: Hansjoerg Znoj, Prof. Dr. phil. Dep. of Clinical Psychology and Psychotherapy, University of Berne
Study Director: Helene Hofer, Dr. phil. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Study Director: Martin Grosse Holtforth, Prof. Dr. phil. University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
Study Director: Rene M Mueri, Prof. Dr. med. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Principal Investigator: Eveline Frischknecht, lic. phil. Dep. of Clinical Psychology and Psychotherapy, University of Berne
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Hansjoerg Znoj, University of Bern, Department of Clinical Psychology and Psychotherapy
ClinicalTrials.gov Identifier: NCT01112969     History of Changes
Other Study ID Numbers: OSCAR, SNF-100014-124574, 2009-2012, 1784 -Bern University Hospital
Study First Received: April 5, 2010
Last Updated: December 27, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Internet-based supportive coaching
guided self-help
Caregivers
Brain Injury
Caregiver Burden
Coping
Stress
Depression

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 18, 2014