Behavioral Intervention for Insomnia in Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Intervention for Insomnia in Older Adults

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulus control therapy<br>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 | Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)<br>* Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.<br>|
| Experimental: sleep restriction therapy<br>Sleep restriction therapy consolidates sleep by restricting the amount of time spent in bed and limiting sleep to a specific time period . | Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)<br>* Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.<br>|
| Experimental: multi-component intervention<br>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 | Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)<br>* Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective sleep | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insomnia severity | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Initiation and Maintenance Disorders, Behavior Therapy