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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Bergen
• Treatments: Zopiclone

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