Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
Information source: University of Bergen
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Cognitive behavior therapy (CBT) (Behavioral); Zopiclone (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Bergen Official(s) and/or principal investigator(s):
Inger H Nordhus, PhD, Study Director, Affiliation: University of Bergen
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 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.
Clinical Details
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Eligibility
Minimum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
University of Bergen, Bergen 5020, Norway
Additional Information
Related publications: Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, Nielsen GH, Nordhus IH. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA. 2006 Jun 28;295(24):2851-8.
Starting date:
January 2004
Ending date: December 2005
Last updated: July 17, 2006
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