Effects of a supportive German online program for people with depression or adjustment

ISRCTN	ISRCTN02446836
DOI	https://doi.org/10.1186/ISRCTN02446836
Secondary identifying numbers	DRKS00004616

Submission date: 03/01/2013
Registration date: 05/02/2013
Last edited: 19/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 aged between 18 and 65 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 is compared to online available weekly information texts on depression and health. Participants are randomly allocated 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 are 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 are 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 are able to use the usually fee-based online program for free. Those who are allocated to the control group with the online offered information texts 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. Participating in the study cannot replace medical consultations or therapy. Participants are reminded to use medical and therapeutic services when needed.

Where is the study run from?
Leuphana University Lueneburg (Germany)

When is the study starting and how long is it expected to run for?
January 2013 to January 2014

Who is funding the study?
The federal state of Lower Saxony and the European Regional Development Fund

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

Contact information

Prof Wulf Roessler
Scientific

Rotenbleicher Weg 67
Lueneburg
21335
Germany

Phone	+49 (0)4131 677 7666
Email	roessler@dgsp.uzh.ch

Study information

Study design	Prospective randomized controlled longitudinal study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Effects of a supportive German online program for people with depression or adjustment: a randomized controlled trial
Study objectives	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(s)	Committee on ethical issues in research at Leuphana University Lueneburg, 05/12/2012
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	14/01/2013
Completion date	15/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	608
Key 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
Key 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")
Date of first enrolment	14/01/2013
Date of final enrolment	15/01/2014

Locations

Countries of recruitment

Germany

Study participating centre

Rotenbleicher Weg 67

Lueneburg
21335
Germany

Sponsor information

NBank (Germany)
Other

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

Website	http://www.efre.niedersachsen.de
"ROR"	https://ror.org/03h3mye18

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/06/2017		Yes	No

Editorial Notes

19/06/2017: Publication reference added.