Trial document




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  DRKS00005980

Trial Description

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Title

Diagnostics and treatment of chronic insomnia in adolescents using an electronic sleeplog

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Chronic Insomnia (complaints about sleep quality or quantity with substantially impairment of day time performance) are reported to be common in all age groups. While children depend mostly on parental behavior, adolescents become more and more independent, therefore self management becomes more and more important. To successfully deal with sleep disturbed teenagers, it is essential to gather data based on retrospection (interviews, questionnaires) but also by using sleep logs under everyday-life conditions. Electronic devices could serve as valuable tools in this concern. We offer an assessment and treatment program ("Sleep Training": 4 modules, 7 meetings in 10 weeks, single or group setting) to adolescents (14-18 years) including an electronic sleep log application programmed for a common handheld computer (iPod) and describe effects compared to waiting list. Sleep problems not necessarily have to be the only problems in our patient target group. For example disorders of anxiety or depression are well known to be associated with sleep problems. As the need for essential information about sleep and techniques to cope with sleep problems definitively is present in these patients too they shall not be excluded in our study.

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Brief Summary in Scientific Language

A prospective interventional study is carried out to show feasibility and treatment effects of our treatment program (Cologne treatment program for sleep disorders) in 14-18 year old chronic insomniacs (ICD 10: F51) with or without comorbid psychiatric conditions. Waiting list serves to control treatment effects.

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Organizational Data

  •   DRKS00005980
  •   2014/03/21
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  •   yes
  •   Approved
  •   13-150, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1154-5957 
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Health Condition or Problem studied

  •   F51 -  Nonorganic sleep disorders
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Interventions/Observational Groups

  •   1) Recruitment & Baselineassessment (2 weeks)
    2) waiting list (8-10 weeks)
    3) intervention (8-10 weeks)
    4) follow up (6 months after recruitment).

    Intervention: cognitive behavioral therapy in group- or single setting, six meetings on a weekly base, followed by a "booster session" after 3 weeks.

    Following two diagnostic sessions a patient can be included. After waiting for 8-10 weeks for every patient intervention takes 8-10 weeks as well.
    The intervention will consist of seven sessions (each 90 minutes) with cognitive behavioral therapy in group or single setting, the first six sessions on a weekly base, the last one follows three weeks later. Time between sessions have to be used by patients to practice and consolidate what has been learned in the sessions. 14 days of sleep log have to be done at the start and ending of the intervention. Questionnaire data from 1) - 4) show changes in sleep quality (primary endpoint) and other problem scores (sec. endpoints).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Improvement of sleep quality measured by the german version of the PSQI (pittsburgh sleep quality index) questionnaire.

Changes over 10 weeks of intervention are compared to 10 weeks of waiting. Follow up (6 months after recruitment) has to show longterm stability of treatment effects.

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Secondary Outcome

Improvement of further sleep related (Questionnaires: Cologne Sleep Inventory, Insomnia Severity Index) and broader clinical problem scores (Questionnaires: BDI 2, Achenbach Scales).

Changes over 10 weeks of intervention are compared to 10 weeks of waiting. Follow up (6 months after recruitment) has to show longterm stability of treatment effects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/24
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion Criteria ICD 10: F 51

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Exclusion Criteria

Acute or chronic psychiatric and/or organic problems that have to be treated urgently by other means. Interactions with running treatment (pharmacologic or non pharmacologic) are anticipated or turn out to be adverse. Developmental disorders with mental retardation based on clinical impression.

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Addresses

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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters
    • Mr.  Prof. Dr. Dipl. Psych. Lehmkuhl  Gerd  Lehmkuhl 
    • Robert Koch Str. 10
    • 50931  Köln
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Universitätsklinik Köln
    • Mr.  Dr. med. Dipl. Psych.  Dirk  Alfer 
    • Robert Koch Str. 10
    • 50931  Köln
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Universitätsklinik Köln
    • Mr.  Dr. med. Dipl. Psych.  Dirk  Alfer 
    • Robert Koch Str 10
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Marga und Walter Boll-Stiftung
    • 50170  Kerpen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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