Status:
COMPLETED
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
Lead Sponsor:
University of Bergen
Conditions:
Insomnia
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suf...
Eligibility Criteria
Inclusion
- age 55 years or older
- fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep
- duration of at least 3 months
- complaints of impaired daytime functioning.
Exclusion
- use of hypnotic medication the last 4 weeks before project start
- use of antidepressive or antipsychotic medications
- signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination
- presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I)
- presence of sleep apnea defined as (A/H index \> 15) or periodic limb movements during sleep (PLM index with arousal \> 15),
- working nightshifts and unable or unwilling to discontinue this work pattern,
- willingness or inability to stop taking sleep medication before start
- having a serious somatic conditions preventing further participation
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00295386
Start Date
January 1 2004
End Date
December 1 2007
Last Update
January 6 2009
Active Locations (1)
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1
University of Bergen
Bergen, Bergen, Norway, 5020