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

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.

Study Overview

• Status: Terminated
• Conditions: Brain Injury; Caregivers
• Intervention / Treatment: Behavioral: Internet-based supportive coaching OSCAR; Other: Waiting-list control group (TAU)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Dep. of clinical psychology and psychotherapy, University of Berne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
OTHER: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	14 months after baseline (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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."	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.	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.	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.	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.	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."	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."	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."	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.	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.	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.	14 months after baseline (follow-up)

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne; Swiss National Science Foundation
• Investigators: Study Chair: Hansjoerg Znoj, Prof. Dr. phil., Dep. of clinical psychology and psychotherapy, University of Berne; Principal Investigator: Eveline Frischknecht, lic. phil., Dep. of clinical psychology and psychotherapy, University of Berne

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 5, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (ESTIMATE): April 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Stress; Caregiver Burden; guided self-help; Brain Injury; Caregivers; Coping; Internet-based supportive coaching
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: OSCAR; SNF-100014-124574, 2009-2012; 1784 -Bern University Hospital