Plain English Summary
Background and study aims
The aim of the study is to improve the treatment (triage) and the diagnostic procedure for insured people with disabilities (e.g. in the mental health or work related area) after an accident.
Who can participate?
Insured people with disabilities (e.g. in the mental health or work related area) eight weeks after an accident, aged at least 18
What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention is a psychological intervention and/or work related intervention based on the principles of cognitive behavioral therapy. Participants in the intervention group receive individual treatment depending on their disabilities or mental health. Participants in the control group receive treatment as usual. In addition there is a third minimal intervention group. In this group randomly allocated case managers follow a standardized manual to improve the triage of the procedure of the diagnostic process. The intervention and control groups are compared in terms of well-being, work-related satisfaction, and return to the workplace.
What are the possible benefits and risks of participating?
The benefit of participation is the free of charge intervention. There are no possible risks of participation.
Where is the study run from?
University of Bern (Switzerland)
When is the study starting and how long is it expected to run for?
September 2011 to December 2013
Who is funding the study?
SUVA (Switzerland)
Who is the main contact?
Prof. Hansjörg Znoj
hansjoerg.znoj@psy.unibe.ch
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hansjörg Znoj
ORCID ID
Contact details
Institute of Psychology
Department of Clinical Psychology and Psychotherapy
University of Bern
Gesellschaftsstrasse 49
Bern
3012
Switzerland
+41 (0)31 631 45 91
hansjoerg.znoj@psy.unibe.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OptiFAB
Study information
Scientific title
Improving the diagnostic procedure for injured patients: a randomised controlled trial
Acronym
OptiFAB
Study hypothesis
1. A significant difference in psychological and work-related outcome is expected between groups (OptiFAB and FABpur). Specifically, it is assumed that the group with the psychological and/or work-related intervention will have better outcomes in terms of psychological functioning (well-being) and a faster reintegration into the workplace.
2. A difference in term of a better triage is expected between groups (FABplus and FABpur). As above, it is assumed that the group with a GAS training and a manual will have better and faster triage process.
Ethics approval
Philosophical - Human Sciences Faculty Ethics Commission of Bern (Switzerland), 08/06/2011, ref: 2011-04-172
Study design
Blinded randomized experimental intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet [in German]
Condition
Different disabilities after an accident in the area workplace and/or mental health
Intervention
OptiFAB: Psychological intervention or / and work related intervention and Control group
Treatment arm OptiFAB: The intervention consists of 10-20 weekly sessions: structured setting and a combination of educational and supportive coaching elements.
FABplus: Improvement of triage process. A group of case manager receives a "Goal attainment Scale" training and a manual (summarized "the good practice" to faster the triage process)
FABpur: Treatment as usual
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Psychological well-being, measured using BFW/E (Berner Fragebogen zum Wohlbefinden, Grob et al., 1991; 39 Items) 8 weeks after the accident
2. Work-related satisfaction, measured using general job satisfaction (Baillod & Semmer, 1994, 4 Items) 8 weeks after the accident
3. Return to the workplace
Secondary outcome measures
1. Psychosocial conditions and health, measured using:
1.1. Subjective Happiness Scale (SHS, Lyubomirsky & Lepper, 1999, 4 Items)]
1.2. Social support (SALSA, Skala zur Erfassung der sozialen Unterstützung am Arbeitsplatz, IRES-3)
1.3. Fear-Avoidance Beliefs questionnaire (FABQ-d, Staerkle et al, 2004, 16 Items)
2. Coping, self-efficacy, optimism, measured using:
2.1. CISS (short version, Kälin, 2003, 19 Items)
2.2. SWE (Selbstwirksamkeit, Schwarzer, 1993, 10Items)
2.3. LOT-R (Optimism, Glaesmer & Hoyer, 2003, 10 Items)
Data collected 8 weeks after the accident
Overall trial start date
01/09/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients 8 weeks after an accident have to fullfil followed criteria:
1. Approved accident or occupational disease
2. Unlimited employment contract
3. There must be at least 90 days or more between accident data and employment date
4. NCM-Code > 1
5. Present inability to work
6. No unemployment
7. No full working capacity in the next two weeks
8. Identified as a potential complex case by the questionnaire Arbeit und Befinden (FAB)
9. Able to speak German
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
For each group 100 participants and a total of 400 participants
Participant exclusion criteria
1. Inability to communicate or lack of language skills
2. Limited employment contract
3. Between accident data and employment date are less than 90 days
4. NCM-Code < 1
5. Ability to work
6. Unemployment
7. Full working capacity in the next two weeks
8. No complex case
9. Under 18 years of age
10. Not willing to participate in the study
Recruitment start date
01/09/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Bern
Bern
3012
Switzerland
Sponsor information
Organisation
SUVA (Switzerland)
Sponsor details
Postfach
Fluhmattstrasse 1
Luzern
6002
Switzerland
-
vmd.bereich@suva.ch
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
SUVA (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list