Trial document





This trial has been registered retrospectively.
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  DRKS00007888

Trial Description

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Title

Effects of an online intervention for depression on mood and positive symptoms in psychosis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The present study examined whether a generic and unguided online training for depression can ameliorate depressive symptoms in schizophrenia and perhaps also ameliorate negative and positive symptoms.

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Brief Summary in Scientific Language

Depression is common in schizophrenia.

Depression in schizophrenia is both underdiagnosed and undertreated. To reduce the large treatment gap in the disorder, low threshold strategies are urgently needed. Online treatment and bibliotherapy may represent valuable tools to address patients’ needs beyond the treatment of the core positive syndrome.


The present study examined whether a generic and unguided online training for depression can ameliorate depressive symptoms in schizophrenia and perhaps also ameliorate negative and positive symptoms.
Patients were recruited via an established email data base of former inpatients and Internet forums. Following an online survey which encompassed the Center for Epidemiologic Studies-Depression Scale (CES-D, primary outcome), PHQ-9 and the Paranoia Checklist, telephone interviews were conducted to assess symptom severity (Positive and Negative Syndrome Scale, PANSS) and verify diagnostic status. Subsequently, patients were randomized either to the experimental condition which had access to an unguided online depression intervention (novego®) versus a waitlist control condition. Three months after inclusion, a reassessment was carried out (self-report and telephone interview).

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Organizational Data

  •   DRKS00007888
  •   2015/03/19
  •   [---]*
  •   yes
  •   Approved
  •   SM042012_amd022014_amd052014, Deutsche Gesellschaft für Psychologie (DGPs)
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
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Interventions/Observational Groups

  •   Experimental Condition (Novego Group).

    The web-based intervention program involves 12 weekly scheduled modules, which are derived from a pool of 17 modules. The individual set is composed according to the replies from a pre-assessment which is performed prior to starting the program. Thus, every user receives a program tailored to their individual needs. Each module requires 45 to 60 minutes to complete. A video moderation leads through the program. The program also includes interactive exercises and practice sheets, humorous illustrations, photographs, animations and audios. Motivational SMS (optional) and email reminders are provided by the psychological team.
  •   Control Condition (waitlist)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Center for Epidemiologic Studies-Depression Scale (CES-D): a 20 item questionnaire covering depressive symptoms. Two measuring times: Baseline and Post-assessment (3 month after baseline)

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Secondary Outcome

Patient Health Questionnaire (PHQ-9): self-report instrument derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) with nine items representing the nine diagnostic criteria for depression in the DSM-IV; Positive and Negative Syndrome Scale (PANSS) depression item (g6); Paranoia Checklist. Two measuring times: Baseline and Post-assessment (3 month after baseline)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2014/07/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Age: 18 - 65 years; informed consent; PHQ-9 sumscore between 5 and 14 (= mild to moderately depressive); a diagnosis of schizophrenia; internet access; fluent in the German language

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Exclusion Criteria

Acute suicidality (SBQ -R sumscore higher 7) as well as an existing diagnosis of a bipolar disorder. In addition, acute mental or physical disorders requiring treatment must be excluded and patients that are not considered as being in state for self-help therapy.

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Addresses

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    • Universitätsklinik Hamburg- Eppendorf, Klinik für Psychiatrie und Psychotherapie
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Klinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. phil.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinik Hamburg- EppendorfKlinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. phil.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit (BMG)
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/15
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Trial Publications, Results and other Documents

  •   Moritz, S., Schröder, J., Klein, J.P., Lincoln, T.M., Andreou, C., Fischer, A. & Arlt, S. (2016). Effects of online intervention for depression on mood and positive symptoms in schizophrenia. Schizophrenia Research, 175, 216-222.
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