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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cognitive behavior therapy (CBT)

Intervention Type BEHAVIORAL

Zopiclone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes