Trial document





This trial has been registered retrospectively.
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  DRKS00014338

Trial Description

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Title

Sleep and study - pilotstudy I: Sleep problems in college and university students - an assessment

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Trial Acronym

SWIS-I

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URL of the Trial

http://www.uni-bielefeld.de/psychologie/abteilung/arbeitseinheiten/07//Stud.%20wie%20im%20Schlaf/

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Brief Summary in Lay Language

"Studieren wie im Schlaf" (sleep and study; SWIS) is a sleep training for students with poor sleep quality. the sleep training contain six sessions, based om cognitive behavior techniques as well as hypnotherapeutic coping strategies. Goal is to enhance the sleep quality and quality of life. Students suffering from sleep problems can participate. We hypothesize that SWIS will enhance sleep and mental condition.

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Brief Summary in Scientific Language

"Studieren wie im Schlaf" (sleep and study; SWIS) is a sleep training for students with a poor sleep quality according to the Pittsburgh Sleep Quality Index, insomnia symptoms or nightmares or delayed sleep-phase syndrome based on ICSD-3 or DSM-5 criteria. Participants are randomly allocated to an intervention condition or a wait-list control condition. All students receive an extensive diagnostic including eight days of actigraphy and a two week sleep log (pre-test). Afterwards, students are divided into groups of four to eight participants. These groups receive six weeks of weekly group training sessions (100 min). In these manualized sessions, cognitive behaviour therapeutic (CBT-I) as well as hypnotherapeutic coping strategies (HT-I) are implmented. Trainers are psychologists. After the training, participants are assessed with the same instruments that were used during the pre-test. After three months, students complete the online follow-up measurement that only contains the questionnaires. Students in the wait-list control condition wait for six weeks after they complete their pre-test and then receive another diagnostic. Subsequently, they are offered the SWIS sleep training.

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Organizational Data

  •   DRKS00014338
  •   2018/04/20
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  •   yes
  •   Approved
  •   2014-135, Ethikkommission der Universität Bielefeld
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Secondary IDs

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Health Condition or Problem studied

  •   F51.0 -  Nonorganic insomnia
  •   F51.5 -  Nightmares
  •   F51.2 -  Nonorganic disorder of the sleep-wake schedule
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Interventions/Observational Groups

  •   Group-training: Studiends participate in groups (4-8 participants). Training contains 6 sessions with 100 minutes each. In manualized sessions students learn sleep hygene-techniques, cognitive-behavoiral techniques (CBT-I) and hypnotherapeutic strategies (HT-I) to overcome their sleep problems. Data are collected before, after and three months after treatment.
  •   Students of the waiting list condition complete pre-measurement, followed by a waiting period of 6 weeks. Afterwards they complete another diagnostic procedure and are then invited to participate in the training.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment, Other
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Enhancement of sleep quality.
Measurements: pre-post, 3 months follow-up.
Methods:
sleep log (2 weeks)
actigraphy (8 days)
Morningness-Eveningness-Questionnaire (MEQ)
Pittsburgh Sleep Quality Index (PSQI)
Self-developed questionnaire for the assessment of insomnia and irregular sleep-wake type according to DSM-5
Specific personality traits of people with sleep disorders (FEPS-II)
Dysfunctional cognitions about sleep (MZS)

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Secondary Outcome

Enhancement of mental impairments.
Measurements: pre-post, 3 months follow-up.
Questionnaires:
Quality of Life (QoL)
Depression Scale (ADS)
Stress Coping strategies short form 78 (SVF-78)
Patient Health Questionnaire (PHQ-D)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/04/14
  •   33
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

impaired sleep quality

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Exclusion Criteria

Schizophrenia, PTSD (Posttraumatic stress disorder)

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Addresses

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    • Universität Bielefeld
    • Universitätsstrasse 25
    • 33615  Bielefeld
    • Germany
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    • Bielefeld University
    • Ms.  Prof. Dr.  Angelika  Schlarb 
    • Universitätsstrasse 25
    • 33615  Bielefeld
    • Germany
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    • Universität Bielefeld, AE07
    • Ms.  MSc  Anja  Friedrich 
    • Universitätsstrasse 25
    • 33615  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Universität Bielefeld
    • Universitätsstrasse 25
    • 33615  Bielefeld
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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