Trial record 1 of 30 for:
Behavioral Intervention for Insomnia in Older Adults
Behavioral Intervention for Insomnia in Older Adults
This study has been completed.
Sponsor:
Carl T. Hayden VA Medical Center
Information provided by:
Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT01154023
First received: June 28, 2010
Last updated: June 29, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Initiation and Maintenance Disorders |
Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Behavioral Intervention for Insomnia in Older Adults |
Resource links provided by NLM:
Further study details as provided by Carl T. Hayden VA Medical Center:
Primary Outcome Measures:
- subjective sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 Outcome Measures:
- insomnia severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
| Enrollment: | 179 |
| Study Start Date: | September 2000 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: stimulus control therapy
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)
Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
|
|
Experimental: sleep restriction therapy
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)
Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
|
|
Experimental: multi-component intervention
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)
Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
No publications provided by Carl T. Hayden VA Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dana R. Epstein, Carl T. Hayden Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT01154023 History of Changes |
| Other Study ID Numbers: | R29NR04951 |
| Study First Received: | June 28, 2010 |
| Last Updated: | June 29, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Carl T. Hayden VA Medical Center:
|
Sleep Initiation and Maintenance Disorders Behavior Therapy |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013