Behavioral Intervention for Insomnia in Older Adults

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Behavioral Intervention for Insomnia in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154023
• Other study ID #: R29NR004951
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: June 29, 2010
• Start date: September 2000
• Est. completion date: August 2004

Study information

• Verified date: June 2010
• Source: Carl T. Hayden VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carl T. Hayden VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No