Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/08/2011
Date assigned
08/12/2011
Last edited
11/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.suva.ch/english/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/07/2017: Plain English summary added.