Condition category
Mental and Behavioural Disorders
Date applied
03/01/2013
Date assigned
05/02/2013
Last edited
05/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mental illness and behavioral disorders are a major cause of disability and incapacity of work. Scientific studies revealed that the average waiting time from diagnosis to admission to treatment is about five months. Psychological counseling over the internet has the potential to bridge this waiting time. Online applications are characterized by an easy access and the possibility of anonymous usage and could fill supply gaps in underserved regions. The aim of this study is to find out how well a supportive German online program for people with depression or adjustment disorder works in order to alleviate (improve) symptoms and reduce the number of sick days. Considering the rising expenditures of the German health care system for mental disorders, this research project could dedicate important findings for an alternative support system for people suffering from depression or adjustment disorders.

Who can participate?
Women and men between 18 and 65 years with mild to moderate depression or adjustment disorder who are insured by the commercial insurance KKH in Germany.

What does the study involve?
The individualized self-help-program will be compared to online available weekly information texts on depression and health. Participants will receive a personal pseudonymized [process of replacing personally identifiable data with a pseudonym, in order to address privacy concerns] code and are randomly assigned to one of the two groups. Over a period of 12 months beginning in January 2013, online surveys on the health status of the study participants will be conducted at five different times. The online questionnaire is based on standardized diagnostic instruments and was developed in-house. Outcome measures include the alleviation of symptoms and a reduction of sick days. Furthermore, the use of medical care as well as aspects of self-efficacy and the quality of life will be obtained. Analyses will be carried out including anonymized secondary data/routine records of the KKH insurance company.

What are the possible benefits and risks of participating?
The individualized self-help-program is an additive offer of support beyond basic and customary care and may help participants to better manage their symptoms. Participants will be able to use the usually fee-based online program for free. Those who are randomized to the control group with the online offered information texts will have the opportunity to use the individualized self-help program free of cost once the study is completed.
A negative impact on the health of participants is not expected but cannot be ruled out on a case-by-case basis.
It will be recalled that participating in the study cannot replace medical consultations or a therapy. Participants will be reminded to use medical and therapeutic services when needed.

Where is the study run from?
The study is carried out by the Leuphana University Lueneburg.

When is the study starting and how long is it expected to run for?
The study started in January 2013 and will run for 12 months followed by analyses.

Who is funding the study?
The study is funded by the federal state of Lower Saxony, the European Regional Development Fund.

Who is the main contact?
Dr. Joern Moock , Supervisory project coordinator
joern.moock@inkubator.leuphana.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wulf Roessler

ORCID ID

Contact details

Rotenbleicher Weg 67
Lueneburg
21335
Germany
+49 (0)4131 677 7666
roessler@dgsp.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS00004616

Study information

Scientific title

Effects of a supportive German online program for people with depression or adjustment: A randomized controlled trial

Acronym

Study hypothesis

It is expected that an individualized supportive online program in comparison with a non-specific online-based information on depression and health will be more effective in improving disease progression.

Ethics approval

Committee on ethical issues in research at Leuphana University Lueneburg, 05/12/12

Study design

Prospective randomized controlled longitudinal study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild depressive episode, Moderate depressive episode, Recurrent depressive disorder, current episode mild, Recurrent depressive disorder, current episode moderate, Dysthymia, Adjustment disorders

Intervention

Intervention: online intervention with 12 weekly training sessions based on the individual needs of the user including video, audio and written information as well as specific assistance to deal with depressive symptoms.

Control: 12-week online-based written information on depression and health. The written information contains texts, instructions and suggestions for a healthy lifestyle.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improvement of depressive symptoms or symptoms of adjustment disorder (weekly screening by the PHQ-9; pre-post measurement with two follow-ups by the BDI-II)

Secondary outcome measures

1. Reduction of sick days (routine data analysis)
2. Positive effects on patient reported outcomes (PROs; including quality of life, self-efficacy, physical and mental stress symptoms measured by EQ-5D, MANSA, ASF, SCL-14)
3. The use of disease-related services covered by the German statutory health insurance (SHI) (e.g. prescriptions, doctor consultations and hospitalization from routine data analysis)

Overall trial start date

14/01/2013

Overall trial end date

15/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. The target group consists of insurants of the commercial insurance KKH with a principal diagnosis of mood disorders (F32.0, F32.1, F33.0, F33.1 and F34.1) or adjustment disorder (F43.2) at an age between 18 to 65 years, either sex.
2. Current incapacity to work certificate and an Internet access/e-mail account

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

608

Participant exclusion criteria

1. Presence of severe depression
2. Risk of suicide (dedicated collection of active and passive suicidal tendencies)
3. Missing declaration of consent ("informed consent")

Recruitment start date

14/01/2013

Recruitment end date

15/01/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Rotenbleicher Weg 67
Lueneburg
21335
Germany

Sponsor information

Organisation

NBank (Germany)

Sponsor details

European Regional Development Fund (Europäischer Fonds für Regionale Entwicklung Land Niedersachsen)
Günther-Wagner-Allee 12-16
Hannover
30177
Germany

Sponsor type

Other

Website

http://www.efre.niedersachsen.de

Funders

Funder type

Government

Funder name

Federal state of Lower Saxony (Germany) - The European Regional Development Fund, within the framework of the Innovation-Incubator at Leuphana University Lueneburg

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