Behavioral Intervention for Insomnia in Older Adults

Carl T. Hayden VA Medical Center

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01154023

R29NR004951

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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179 participants in 3 patient groups

stimulus control therapy

Experimental group

Description:

Focuses on strengthening the bed and bedroom as cues for sleepiness and sleep, weaken them as cues for arousal, and developing a consistent sleep-wake pattern

Treatment:

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

sleep restriction therapy

Experimental group

Description:

Sleep restriction therapy consolidates sleep by restricting the amount of time spent in bed and limiting sleep to a specific time period .

Treatment:

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

multi-component intervention

Experimental group

Description:

Combines stimulus control and sleep restriction: strengthen the bed and bedroom as cues for sleepiness and sleep, weaken them as cues for arousal, develop a consistent sleep-wake pattern, consolidate sleep by restricting the amount of time spent in bed and limit sleep to a specific time period

Treatment:

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