Trial document




drksid header

  DRKS00003564

Trial Description

start of 1:1-Block title

Title

Health Economic Evaluation of costs and benefits of a computer based program called "Deprexis" used for insured persons of the DAK (statutory health insurance) suffering from depression

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Study "Deprexis"

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.deprexis.de/de/dak-gesundheit

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The main aim of this study is to analyse weather persons suffering from depression and treated by a computer based program called "Deprexis" save costs for the Statutory Health Insurance. Furthermore the study tries to prove that the program reduces depression and that quality of life, social functioning, satisfaction improve also by the application of "Deprexis". No physical medication is applied. All willing persons that suffer from depression and would like to take part in the program (insured persons of the DAK (Statutory Health Insurance in Germany)) are divided into two groups by random. One group - the intervention group - uses the program for a period of twelve weeks. The other group - the control group has no access to "Deprexis" and will serve to control the results concerning the above mentioned outcome measures.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Persons suffering from depressions are severely negatively influenced in their life. The treatment of depression is supposed to be the more successful the earlier it is recognised and treated.

There are several reasons for using an internet based program to treat depressions:
(1) The lacking availability of offers, particular in regions outside of bigger towns and long waiting times. (2) The stigma that comes along with depressions and therefore the avoidance to seek for help. (3) The limitation regarding time of conventional treatment and the problem for working people to cope with their job plus treatment at the same time. (4) Particular high costs of conventional treatment.

The primary aim is to measure weather costs are lower up to one year after access to the program in an intervention group that has used "Deprexis" for a period of 12 weeks compared to a control group without access to "Deprexis". Secundary aims that are measured and compared betweeen both groups are benefits regarding quality of life in social, job related means and satisfaction with the service of the statutory health insurance (DAK).

The persons to be observed have to suffer at least from a mild form of depression measured by the PHQ-9 - a questionnaire that is widely used when observing effects of depression. It is expected that the program has positive effects on both - costs and benefits - and proves to be a cost-saving alternative way of treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003564
  •   2012/02/17
  •   [---]*
  •   yes
  •   Approved
  •   2011-516-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The intervention group uses the program Deprexis for a period of 12 weeks. The Questionnaires applied measure:
    Depression: PHQ-9, quality of life: SF12 and EQ-5D, Questionnaire working and adjustment scale: WSAS. Costs are supllied by the statutory health insurance DAK (except ambulant costs). Acceptance with service of the DAK and the program Deprexis.
  •   The control group does not get access to the program "Deprexis". The Questionnaires measure:
    Depression: PHQ-9, quality of life: SF12 and EQ-5D, Questionnaire working and adjustment scale: WSAS. Costs are supllied by the statutory health insurance DAK (except ambulant costs). Question, wheather they really did not get in contact with Deprexis during the observation period.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Health economics
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

costs, that occured in a period of one year after the end of treatment determined by the DAK (Statutory Health Insurance)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Quality of life measured by the SF12 and the EQ-5D at the beginning (T0), after 12 weeks (T1), after 6 months (T2) and after 12 months (T3). The severity of depression: by the PHQ-9 at the beginning (T0), after 12 weeks (T1), after 6 months (T2) and after 12 months (T3). The social functioning: measured by the WSAS at the beginning (T0), after 12 weeks (T1), after 6 months (T2) and after 12 months (T3).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/02/17
  •   5400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(a) At least a mild depression: PHQ-9 >= 5
(b) age of at least 18 years
(c) Informed Consent
(d) Insured by the DAK at least for one year and availabilty of costs one year before and one year after the treatment with "Deprexis"
(e) Access to the internet

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Danger of suizidal tendencies; measured by item number 9 of the questionnaire PHQ-9 (value > 0)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • D A K - Gesundheit Unternehmen Leben Vorstandsreferat Versorgungsforschung (0010 30)
    • Ms.  Dr. med.  Elke  Scharnetzky 
    • Nagelsweg 27-31
    • 20097  Hamburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Fakultät für Gesundheitswissenschaften Arbeitsgruppe 5: Gesundheitsökonomie und Gesundheitsmanagement
    • Mr.  Prof. Dr.  Wolfgang  Greiner 
    • Universitätsstraße 25
    • 33615  Bielefeld
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Fakultät für Gesundheitswissenschaften Arbeitsgruppe 5: Gesundheitsökonomie und Gesundheitsmanagement
    • Mr.  Prof. Dr.  Wolfgang  Greiner 
    • Universitätsstraße 25
    • 33615  Bielefeld
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • DAK Hamburg
    • Nagelsweg 27-31
    • 20097  Hamburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/05/19
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.