Behavioral Intervention for Insomnia in Older Adults

• Sponsor: Carl T. Hayden VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01154023
• Collaborator: (none)
• Enrollment: 179
• Arms: 3
• Duration (Months): 47

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders	Behavioral: stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Behavioral Intervention for Insomnia in Older Adults
• Study Start Date: Sep 1, 2000
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. subjective sleep [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 Outcome Measures

1. insomnia severity [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Carl T. Hayden VA Medical Center

Investigators

• Principal Investigator: Dana R Epstein, PhD, RN, Carl T. Hayden VA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01154023
• Other Study ID Numbers: R29NR004951
• First Posted: Jun 30, 2010
• Last Update Posted: Jun 30, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Sleep Initiation and Maintenance Disorders; Behavior Therapy
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jun 30, 2010