CaregiversPhase 2NCT01112969
OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury
A Phase 2 study testing Internet-based supportive coaching OSCAR in people with Caregivers and Brain Injury, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers, Brain Injury
- What is being tested?
- Internet-based supportive coaching OSCAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute suicidal tendency
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of clinical psychology and psychotherapy, University of Berne
Bern, 3012
About this study
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.
Read the 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).
- Conditions
- Caregivers, Brain Injury
- Being tested
- Internet-based supportive coaching OSCAR, Waiting-list control group (TAU)
- Keywords
- Internet-based supportive coaching, guided self-help, Caregivers, Brain Injury, Caregiver Burden, Coping, Stress, Depression
- Medical subject headings
- Brain Injuries, Caregiver Burden, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based supportive coaching OSCARBehavioural
The Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention
Waiting-list control group (TAU)Other
Waiting-list control group (treatment as usual, TAU, no specific intervention)
| Study group | Role | What they receive |
|---|---|---|
| Internet-based supportive coaching OSCAR | Experimental | Arm 1: Internet-based supportive coaching OSCAR Receives: Behavioral: Internet-based supportive coaching OSCAR |
| Waiting list control group (treatment as usual, TAU) | Other | Not described Receives: Other: Waiting-list control group (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 4 months after baseline
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.
Measured: 8 months after baseline
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.
Measured: 14 months after baseline (follow-up)
Secondary outcomes (12)
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.
Measured: Baseline
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."
Measured: Baseline
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.
Measured: Baseline
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.
Measured: 4 months after baseline
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.
Measured: 8 months after baseline
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.
Measured: 14 months after baseline (follow-up)
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."
Measured: 4 months after baseline
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."
Measured: 8 months after baseline
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."
Measured: 14 months after baseline (follow-up)
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.
Measured: 4 months after baseline
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.
Measured: 8 months after baseline
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.
Measured: 14 months after baseline (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionMar 2013
Why it stopped: Project end after 3 years; prolongation was rejected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
- Investigators
- Hansjoerg Znoj, Prof. Dr. phil., Study chair, Dep. of Clinical Psychology and Psychotherapy, University of BerneHelene Hofer, Dr. phil., Study director, Bern University Hospital, Outpatient Clinic for Cognitive and Restorative NeurologyMartin Grosse Holtforth, Prof. Dr. phil., Study director, University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for DepressionRene M Mueri, Prof. Dr. med., Study director, Bern University Hospital, Outpatient Clinic for Cognitive and Restorative NeurologyEveline Frischknecht, lic. phil., Principal investigator, Dep. of Clinical Psychology and Psychotherapy, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112969
- Sponsor's protocol ID
- OSCAR
- Other IDs
- SNF-100014-124574, 2009-2012, 1784 -Bern University Hospital
- Status last verified
- Jul 2015
- First submitted
- 5 Apr 2010
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury.
- ClinicalTrials.gov ID
- NCT01112969
- Acronym / sponsor ID
- OSCAR
- Conditions
- Caregivers, Brain Injury
- Keywords
- Internet-based supportive coaching, guided self-help, Caregivers, Brain Injury, Caregiver Burden, Coping, Stress, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project end after 3 years; prolongation was rejected
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based supportive coaching OSCAR | Experimental | Behavioral: Internet-based supportive coaching OSCARArm 1: Internet-based supportive coaching OSCAR |
| Waiting list control group (treatment as usual, TAU) | Other | Other: Waiting-list control group (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- acute suicidal tendency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based supportive coaching OSCARThe Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention | Behavioural | Internet-based supportive coaching OSCAR |
| Waiting-list control group (TAU)Waiting-list control group (treatment as usual, TAU, no specific intervention) | Other | Waiting list control group (treatment as usual, TAU) |
Primary outcome
German Zarit Burden Interview (G-ZBI)
Time frame: Baseline
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
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
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)
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.
12 secondary outcomes
Beck Depression Inventory (BDI-II)
Time frame: Baseline
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: Baseline
Perceived Stress Questionnaire (PSQ20)
Time frame: Baseline
Beck Depression Inventory (BDI-II)
Time frame: 4 months after baseline
Beck Depression Inventory (BDI-II)
Time frame: 8 months after baseline
Beck Depression Inventory (BDI-II)
Time frame: 14 months after baseline (follow-up)
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: 4 months after baseline
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: 8 months after baseline
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: 14 months after baseline (follow-up)
Perceived Stress Questionnaire (PSQ20)
Time frame: 4 months after baseline
Perceived Stress Questionnaire (PSQ20)
Time frame: 8 months after baseline
Perceived Stress Questionnaire (PSQ20)
Time frame: 14 months after baseline (follow-up)
Results and safety
The study was stopped early (reason given: Project end after 3 years; prolongation was rejected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hansjoerg Znoj, Prof. Dr. phil. study chair
Dep. of Clinical Psychology and Psychotherapy, University of Berne
Helene Hofer, Dr. phil. study director
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Martin Grosse Holtforth, Prof. Dr. phil. study director
University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Internet-based supportive coaching OSCAR in people with Caregivers and Brain Injury, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Project end after 3 years; prolongation was rejected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
German Zarit Burden Interview (G-ZBI) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.