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Behavioral Intervention for Insomnia in Older Adults

Behavioral Intervention for Insomnia in Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01154023
Enrollment
179
Registered
2010-06-30
Start date
2000-09-30
Completion date
2004-08-31
Last updated
2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Sleep Initiation and Maintenance Disorders, Behavior Therapy

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.

Interventions

BEHAVIORALstimulus 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.

Sponsors

Carl T. Hayden VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
subjective sleep1 yeardaily 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

MeasureTime frameDescription
insomnia severity1 yearInsomnia 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026