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

This study has been completed.
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00295386
First received: February 21, 2006
Last updated: January 2, 2009
Last verified: January 2009
History of Changes
  Purpose

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-Blind
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)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295386

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

Publications:

ClinicalTrials.gov Identifier: NCT00295386     History of Changes
Other Study ID Numbers: REK Vest nr. 186.03
Study First Received: February 21, 2006
Last Updated: January 2, 2009
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zopiclone
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013