Condition category
Mental and Behavioural Disorders
Date applied
15/08/2011
Date assigned
27/10/2011
Last edited
03/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 don’t 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

http://www.online-nachsorge.de/?htmlInformation

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
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 measures

“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

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

http://www.deutsche-rentenversicherung-bund.de

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23351836

Publication citations

  1. 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.

Additional files

Editorial Notes