Trial document




drksid header

  DRKS00017191

Trial Description

start of 1:1-Block title

Title

"Evaluation of the self-help program "Selfapy"on a sample of depressive subjects: A randomized, blinded parallel group study"

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

Trial Acronym


RCT study

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

URL of the Trial

https://www.selfapy.de/

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

Brief Summary in Lay Language

The aim of this study is the evaluation of the effectiveness of the Internet intervention "Selfapy" in depression.

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

Brief Summary in Scientific Language

The objective of this study is to evaluate the effectiveness of Internet intervention "selfapy" in depression with a randomized controlled parallel group study. The aim of the study is therefore to find out whether proven methods of cognitive behavioral therapy in the form of the online self-help program "Selfapy" in people with depressive symptoms lead to a reduction of depressive symptoms and to what extent an additional "therapy accompaniment" by a real psychotherapist provides an increase in effectiveness.

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

Organizational Data

  •   DRKS00017191
  •   2019/06/14
  •   [---]*
  •   yes
  •   Approved
  •   EA4/047/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2019-002616-56 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32 -  Depressive episode
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   unaccompanied self-help program for depression (no drug treatment !!!)
  •   psychological self-help program for depression
  •  
    waiting control group
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. Change in the self-assessment of depressive symptoms after completion of treatment after 12 weeks (pre-post difference of BDI-II).

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

Secondary Outcome

1. Differences in depressive symptoms at follow-up after three months (pre-follow UP difference of HAMD, QUIDS, BDI-II).
2. Change in self-assessment of anxiety-related symptoms after completion of treatment (pre-post difference of BAI).
3. Change in Self-Assessment of Self-esteem (SWOP-K9), Social Activation (SASS), Work Alliance (WAI), Physical Change and Life Satisfaction (WHOQOL) and Online Intervention Settings (APOI) at the end of treatment (pre-post difference of WHOQOL; Rosenberg SWOP - K9; SASS; WAI; APOI).
4. Change in the use of the health system after self-intervention at the time of measurement T3 compared to the waiting group (contact with the health service, number of psychotherapies, number of contacts with the psychiatrist, etc.).

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/08/27
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusion criteria:
- Age (from 18 - 65)
- German language skills
- Possibility for undisturbed internet access
- Score of 12 or higher in the BDI II (Beck-Depressions-Inventar)
- Consent (electronic informed consent)
- Willingness to participate in 4 interviews in the distance
- At least mild depressive episode as main diagnosis (after MINI)

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

Exclusion Criteria

Exclusion criteria:
- Bipolar disorder
- Psychotic illness
- suicidality (operationalized via mini; HRSD-24)
- no German language skills

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • 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
    • Charité Campus Charité Mitte
    • Mr.  Dr.  Stephan  Köhler 
    • Chariteplatz 1, 39
    • 10117  Berlin
    • 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
    • Charité Campus Charité Mitte
    • Mr.  M.Sc  Rico  Krämer 
    • Eisenzahnstraße, 39
    • 10709  Berlin - Wilmersdorf
    • 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
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • 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 ongoing
  •   [---]*
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.