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

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

January 2, 2009

Start Date ^ICMJE

January 2004

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00295386 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Insomnia

Intervention ^ICMJE

Behavioral: Cognitive behavior therapy (CBT)
Drug: Zopiclone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00295386

Responsible Party

Study ID Numbers ^ICMJE

REK Vest nr. 186.03

Study Sponsor ^ICMJE

University of Bergen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Inger H Nordhus, PhD

University of Bergen

Information Provided By

University of Bergen

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP