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

Phase 4

Completed

• Conditions: Insomnia

• Registration Number: NCT00295386
• Lead Sponsor: University of Bergen

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2006-01
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-21
• Study First Posted: 2006-02-23
• Study Completion: 2007-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-02
• Last Update Posted: 2009-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Norway