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Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly

This study has been completed.
Information provided by:
University of Bergen Identifier:
First received: February 21, 2006
Last updated: January 2, 2009
Last verified: January 2009
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 suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.

Condition Intervention Phase
Insomnia Behavioral: Cognitive behavior therapy (CBT) Drug: Zopiclone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Further study details as provided by University of Bergen:

Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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
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Please refer to this study by its identifier: NCT00295386

University of Bergen
Bergen, Norway, 5020
Sponsors and Collaborators
University of Bergen
Study Director: Inger H Nordhus, PhD University of Bergen