NCT01112969

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

April 5, 2010

Last Update Submit

July 22, 2015

Conditions

CaregiversBrain Injury

Keywords

Internet-based supportive coachingguided self-helpCaregiversBrain InjuryCaregiver BurdenCopingStressDepression

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Beck Depression Inventory (BDI-II)

    Baseline

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)

    Baseline

  • Perceived Stress Questionnaire (PSQ20)

    Baseline

  • Beck Depression Inventory (BDI-II)

    4 months after baseline

  • Beck Depression Inventory (BDI-II)

    8 months after baseline

  • +7 more secondary outcomes

Study Arms (2)

Internet-based supportive coaching OSCAR

EXPERIMENTAL

Arm 1: Internet-based supportive coaching OSCAR

Behavioral: Internet-based supportive coaching OSCAR

Waiting list control group (treatment as usual, TAU)

OTHER
Other: Waiting-list control group (TAU)

Interventions

Internet-based supportive coaching OSCARBEHAVIORAL

The Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention

Internet-based supportive coaching OSCAR
Waiting-list control group (TAU)OTHER

Waiting-list control group (treatment as usual, TAU, no specific intervention)

Waiting list control group (treatment as usual, TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • acute suicidal tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of clinical psychology and psychotherapy, University of Berne

Bern, 3012, Switzerland

Location

Related Links

MeSH Terms

Conditions

Brain InjuriesCaregiver BurdenDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Hansjoerg Znoj, Prof. Dr. phil.

    Dep. of Clinical Psychology and Psychotherapy, University of Berne

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Eveline Frischknecht, lic. phil.

    Dep. of Clinical Psychology and Psychotherapy, University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 29, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

March 1, 2013

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CH(1)