Plain English Summary
Background and study aims
Mental and psychosomatic disorders are the leading reasons for work disability and premature pension in Germany and in most other high-income countries. In our previous studies we showed that job-specific interventions during in-patient rehabilitation, like real workplace training or stress management training, could be helpful to improve treatment satisfaction. Patients taking part in these programmes could also improve their vocational reintegration after inpatient rehabilitation. Currently we dont know how patients could transfer these improvements into their daily work. In most studies the improvements achieved during an inpatient rehabilitation treatment fade over time. Most patients are back to their initial health status 12 months after discharge from inpatient rehabilitation.
Aftercare programmes do exist but are not commonly known or accessible. Therefore, the internet offers new possibilities for special internet-based treatments (e.g. counselling interventions). This is groundbreaking because the internet is widely used, with 73.3% of the German population using the internet on a regular basis. The main aim of our study is to analyse if an internet-based aftercare programme could improve vocational reintegration after inpatient rehabilitation. In particular, we want to show if our aftercare programme could help to stabilise the improvements achieved during inpatient rehabilitation concerning subjective vocational stresses as well as health status of participating patients.
Who can participate?
Patients aged 18 to 59 years who are admitted to the participating rehabilitation units because of psychosomatic, orthopaedic and cardiovascular complaints.
What does the study involve?
Patients will be recruited through information from health professionals at the participating rehabilitation clinics at admission to the inpatient rehabilitation treatment. Those who are interested will receive written information about the study. After giving their informed consent 800 patients who meet the above requirements can participate.
Patients will be randomly allocated into one of two groups: the intervention group or the control group. If you are allocated to the intervention group you will get an internet-based aftercare programme following the inpatient treatment. The internet-based aftercare programme consists of: a section with information material to download, a moderated forum, a self-test, and a weekly blog concerning different situations at your workplace, with a commentary from an online therapist. If you are allocated to the control group you will also get access to an internet-based aftercare programme that consists of information material to download concerning stress management, physical training, health behaviour and relaxation techniques.
What are the possible benefits and risks of participating?
The expected benefits of taking part in this aftercare programme include stabilised improvements concerning stress management, coping with conflicts at work and improved vocational reintegration.
There are no known risks to participants.
Where is the study run from?
There are four participating clinics in Germany and the analysing centre is at the University Medical Centre Mainz, Department of Psychosomatic Medicine and Psychotherapy.
When is the study starting and how long is it expected to run for?
The study is running from November 2010 until October 2013.
Who is funding the study?
German Statutory Pension Insurance.
Who is the main contact?
Dr Rüdiger Zwerenz
ruediger.zwerenz@unimedizin-mainz.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rüdiger Zwerenz
ORCID ID
Contact details
University Medical Center of the Johannes Gutenberg-University Mainz
Department for Psychosomatic Medicine and Psychotherapy
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany
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ruediger.zwerenz@unimedizin-mainz.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0423/00-40-65-50-25
Study information
Scientific title
Development and evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation
Acronym
Study hypothesis
In this study we develop and evaluate an internet-based aftercare programme after inpatient medical rehabilitation, with hypotheses as follows:
1. We expect that vocationally strained patients taking part at the internet-based aftercare programme could stabilise the improvements achieved during inpatient rehabilitation concerning stress management and coping with conflicts at the workplace more than the "treatment as usual" control group, resulting in an improved vocational reintegration
2. We expect these effects to be evident up to nine months after the end of the internet-based treatment
On 23/08/2013 the anticipated end date was changed from 31/10/2013 to 31/05/2014.
On 03/07/2014 the anticipated end date was changed from 31/05/2014 to 31/08/2014.
Ethics approval
Medical association of Rhineland-Palatinate Ethics Committee, Mainz [Landesärztekammer Rheinland-Pfalz], 12/01/2011, ref: 837.415.10 (7424)
Study design
Multi centered, prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vocationally strained patients in psychosomatic, orthopaedic and cardiovascular rehabilitation
Intervention
With a cluster randomised controlled intervention study we intend to study overall 800 patients at the beginning (T0) and at the end (T1) of inpatient medical rehabilitation as well as at the end of the aftercare programme (3 months after T1) and 9 months later (12 months after T1).
Patients in the intervention group get the internet-based aftercare intervention, based on a manualised, educational vocational training (Health training stress management at the workplace) they attended during inpatient rehabilitation. Patients of the control group also attend the inpatient training and do not get the special internet-based aftercare programme but obtain access to a placebo internet-based programme (with links to public accessible information about stress management and coping).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Social medical risk index in the screening questionnaire SIBAR (Bürger & Deck, 2009) at follow-up, including subjective prognosis for work, time of sick leave and unemployment as well as wish for pension.
Timepoints:
Screening = T0 = 0 months
Baseline = T1 = after the vocational training (about 3-6 weeks after screening)
End of treatment = T2 = 3 months after baseline diagnostics
Follow-up = T3 = 12 months after baseline diagnostics
Secondary outcome measures
Level of vocational distress, physical and mental health and capability at follow-up.
Timepoints:
Screening = T0 = 0 months
Baseline = T1 = after the vocational training (about 3-6 weeks after screening)
End of treatment = T2 = 3 months after baseline diagnostics
Follow-up = T3 = 12 months after baseline diagnostics
Overall trial start date
01/11/2010
Overall trial end date
31/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Vocationally strained patients in psychosomatic, orthopaedic and cardiovascular rehabilitation:
1. Private internet-access
2. Aged 18-59 years
2. Current occupation (full time, part time)
3. Vocational distress or high demand for vocational training / therapy according to the screening
4. German-speaking
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. Unemployment, pension or no plans to work (e.g. housekeeping) at the beginning of inpatient rehabilitation
2. Severity of physical or psychological complaints, so that it is not possible to take part at the inpatient stress management training
Recruitment start date
01/11/2010
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz
D-55131
Germany
Sponsor information
Organisation
German Statutory Pension Insurance (Deutsche Rentenversicherung Bund) (Germany)
Sponsor details
Ruhrstr.2
Berlin
D-10709
Germany
-
drv@drv-bund.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Statutory Pension Insurance (Deutsche Rentenversicherung Bund) ref: 0423/00-40-65-50-25
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
1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23351836
2. 2017 results in https://doi.org/10.1371/journal.pone.0176513 (added 30/01/2019)
Publication citations
-
Protocol
Zwerenz R, Gerzymisch K, Edinger J, Holme M, Knickenberg RJ, Spörl-Dönch S, Kiwus U, Beutel ME, Evaluation of an internet-based aftercare program to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomized controlled trial., Trials, 2013, 14, 26, doi: 10.1186/1745-6215-14-26.