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

University of Bergen

Status and phase

Completed

Phase 4

Conditions

Insomnia

Treatments

Behavioral: Cognitive behavior therapy (CBT)

Drug: Zopiclone

Study type

Interventional

Funder types

Other

Identifiers

NCT00295386

REK Vest nr. 186.03

Details and patient eligibility

About

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.

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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