Trial document




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  DRKS00016650

Trial Description

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Title

Insomnia not due to a substance or known physiological condition: Treatment protocol for psychosomatic rehabilitation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Intervention research: Developing and analysing a psychotherapeutic treatment protocol administered in rehabilitation clinics for patients with sleep disorders

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Brief Summary in Scientific Language

Development, manualisation and evaluation of a cognitive-behavioural intervention for patients in psychosomatic treatment (in-patient) with non-organic sleep disorders

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Organizational Data

  •   DRKS00016650
  •   2019/02/15
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  •   yes
  •   Approved
  •   GZEK 2019-01, Ethikkommission des Instituts für Psychologie der Humanwissenschaftlichen Fakultät der Julius-Maximilians-Universität Würzburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F43.2 -  Adjustment disorders
  •   F51.0 -  Nonorganic insomnia
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Interventions/Observational Groups

  •   Intervention group: normal rehabilitation programme (for depression/ adjustment disorder) and group and individual therapy for sleep disorders.
    Content: behavioural therapy (group and individual therapy) with cognitive and mindfulness elements as well as time-in-bed-restriction protocols. Based on a new manual for psychosomatic rehabilitation.
    Duration: 4 group sessions, 90 minutes, 2 times a week, over the course of 2 weeks. Time in bed restriction with single therapy sessions over the whole course of the rehabilitation (usually 5 weeks).
  •   control group: normal rehabilitation programme (for depression/ adjustment disorder) without therapy for sleep disorders but with same application rate of therapeutic interventions as the IG
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Increased sleep quality: Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989).
Times of measurement: beginning of rehabilitation, end of rehabilitation, 3 months after the end of rehabilitation

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Secondary Outcome

Increase in Quality of Life: World Health Organization Quality of Life (WHOQOL – BREF; WHO, 1996)
Increase in psychosocial health: Hamburger Module (HEALTH-49; Rabung et al., 2009), Beck Depression Inventory (BDI II; Beck et al., 1992)
Increase in participation in work life: : Arbeitsbezogene Verhaltens- und Erlebensmuster (AVEM; Schaarschmidt, 2006), Work Ability Index short version (WAI; Hasselhorn & Freude, 2007)
Times of measurement: beginning of rehabilitation, end of Rehabilitation, 3 months after the end of rehabilitation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/04/01
  •   264
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with adjustment disorder or depressive episodes (mild or moderate, one episode or recurring) who additionally show symptoms of non-organic sleep disorder

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Exclusion Criteria

Patients with primarily organic sleep disorders, bipolar disorder, psychotic or dissociative symptoms, organic brain disorders, or other disorders that speak against sleep therapy

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Addresses

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    • Universität Würzburg
    • 97070  Würzburg
    • Germany
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    • Institut für Psychologie Lehrstuhl für Psychologie I Arbeitsbereich Interventionspsychologie Universität Würzburg
    • Mr.  Dr.  Clemens  Speth 
    • Marcusstr. 9-11
    • 97070  Würzburg
    • Germany
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    • Institut für Psychologie Lehrstuhl für Psychologie I Arbeitsbereich Interventionspsychologie Universität Würzburg
    • Mr.  Dr.  Clemens  Speth 
    • Marcusstr. 9-11
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • 10704  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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