OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury
Primary Purpose
Caregivers, Brain Injury
Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Internet-based supportive coaching OSCAR
Waiting-list control group (TAU)
Sponsored by
About this trial
This is an interventional supportive care trial for Caregivers focused on measuring Internet-based supportive coaching, guided self-help, Caregivers, Brain Injury, Caregiver Burden, Coping, Stress, Depression
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
Sites / Locations
- Dep. of clinical psychology and psychotherapy, University of Berne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Internet-based supportive coaching OSCAR
Waiting list control group (treatment as usual, TAU)
Arm Description
Arm 1: Internet-based supportive coaching OSCAR
Outcomes
Primary Outcome Measures
German Zarit Burden Interview (G-ZBI)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.
Full Information
NCT ID
NCT01112969
First Posted
April 5, 2010
Last Updated
July 22, 2015
Sponsor
University of Bern
Collaborators
Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT01112969
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Project end after 3 years; prolongation was rejected
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
Collaborators
Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Brain Injury
Keywords
Internet-based supportive coaching, guided self-help, Caregivers, Brain Injury, Caregiver Burden, Coping, Stress, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based supportive coaching OSCAR
Arm Type
Experimental
Arm Description
Arm 1: Internet-based supportive coaching OSCAR
Arm Title
Waiting list control group (treatment as usual, TAU)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Internet-based supportive coaching OSCAR
Intervention Description
The Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention
Intervention Type
Other
Intervention Name(s)
Waiting-list control group (TAU)
Intervention Description
Waiting-list control group (treatment as usual, TAU, no specific intervention)
Primary Outcome Measure Information:
Title
German Zarit Burden Interview (G-ZBI)
Description
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.
Time Frame
Baseline
Title
German Zarit Burden Interview (G-ZBI)
Description
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.
Time Frame
4 months after baseline
Title
German Zarit Burden Interview (G-ZBI)
Description
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.
Time Frame
8 months after baseline
Title
German Zarit Burden Interview (G-ZBI)
Description
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.
Time Frame
14 months after baseline (follow-up)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
Baseline
Title
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Description
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."
Time Frame
Baseline
Title
Perceived Stress Questionnaire (PSQ20)
Description
The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.
Time Frame
Baseline
Title
Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
4 months after baseline
Title
Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
8 months after baseline
Title
Beck Depression Inventory (BDI-II)
Description
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.
Time Frame
14 months after baseline (follow-up)
Title
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Description
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."
Time Frame
4 months after baseline
Title
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Description
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."
Time Frame
8 months after baseline
Title
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Description
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."
Time Frame
14 months after baseline (follow-up)
Title
Perceived Stress Questionnaire (PSQ20)
Description
The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.
Time Frame
4 months after baseline
Title
Perceived Stress Questionnaire (PSQ20)
Description
The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.
Time Frame
8 months after baseline
Title
Perceived Stress Questionnaire (PSQ20)
Description
The Perceived Stress Questionnaire (PSQ20) is the abbreviated 20-item version of the PSQ (Levenstein et al., 1993) and assesses self-reported experienced stress.
Time Frame
14 months after baseline (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansjoerg Znoj, Prof. Dr. phil.
Organizational Affiliation
Dep. of Clinical Psychology and Psychotherapy, University of Berne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helene Hofer, Dr. phil.
Organizational Affiliation
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Grosse Holtforth, Prof. Dr. phil.
Organizational Affiliation
University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rene M Mueri, Prof. Dr. med.
Organizational Affiliation
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eveline Frischknecht, lic. phil.
Organizational Affiliation
Dep. of Clinical Psychology and Psychotherapy, University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of clinical psychology and psychotherapy, University of Berne
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
http://oscar.online-therapy.ch
Description
Related Info
Learn more about this trial
OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury
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