Behavioral Intervention for Insomnia in Older Adults

The purpose of the study was to evaluate and compare the efficacy of single interventions (stimulus control instructions, sleep restriction therapy) and multi-component intervention (stimulus control instructions and sleep restriction therapy) for chronic insomnia in community dwelling older adults. The subjects were randomly assigned to one of four conditions: stimulus control instructions, sleep restriction therapy, multi-component treatment (stimulus control instructions and sleep restriction therapy), or measurement control.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

55 years or older
Sleep onset or maintenance insomnia of 45 minutes or more per night for at least 3 nights per week as ascertained through 14 days of sleep diaries
Insomnia duration of at least 6 months
Impaired daytime functioning as a consequence of insomnia

Exclusion criteria

Psychopathology evidenced by the Brief Symptom Inventory Global Severity Index T score >60
Cognitive impairment as ascertained by the Mini-Mental State Exam score < 27
Current psychotherapy or medical treatment for major depression or other psychopathology
Current and regular use of over-the-counter medication or prescription medication for sleep (verified through urinalysis), or any medication affecting sleep
Major physical or mental illness directly related to the onset and course of insomnia
Substance abuse problem ascertained per interview
Suspicion of sleep apnea as determined by an Epworth Sleepiness Scale score of 11 or greater, a respiratory disturbance index of > 15 as established through in-home overnight use of the EdenTec Model 3711 Digital Recorder, and interview with a significant other, if available
Restless leg syndrome, periodic limb movement disorder, or circadian rhythm sleep disorders as determined through the participant interview and an interview with a significant other, if available.

Treatment and study plan

stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)

Behavioral

Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.

Primary outcomes

subjective sleep

Time frame: 1 year

daily sleep diaries were used for 2 weeks at each of the four measurement points, pre-treatment, post-treatment, 3 months and 1 year - called daily to voice mail service to avoid retrospective estimates of sleep

Secondary outcomes

insomnia severity

Time frame: 1 year

Insomnia Severity Index was used at the four measurement points (pre-treatment, post-treatment, 3 months, and 1 year) and also included the significant other version of the instrument

Sponsors and collaborators

Lead sponsor

Carl T. Hayden VA Medical Center

Fed

Registry information

Important dates

Study start: 2000
Primary completion: 2004
Study completion: 2004
First posted: Jun 30, 2010
Registry last updated: Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed