Insomnia Chronic
Conditions
Brief summary
The proposed study will examine changes in older insomniacs' cognitive functioning following behavioral treatment for insomnia using a combination of two methods. A traditional repeated measures design will be used to look at group level differences based on performance on a neuropsychological battery administered prior to, immediately after, and 3 months after completing a 4 week behavioral treatment program for insomnia. This data will be analyzed using standard repeated measures analytic techniques. A time-series design will also be used to look at within-subject differences based on a brief cognitive battery that will be self-administered on a daily basis. Data from this daily battery will be examined using intraindividual variability modeling.
Interventions
BEHAVIORALBrief Behavioral Therapy for Insomnia
Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.
Sponsors
University of Missouri-Columbia
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>65 years * Community dwelling * Available for duration of study * Insomnia according to American Sleep Disorders Association (1990) criteria: (a) \>30 minutes of unwanted awake time, 3 nights per week for at least 6 months and (b) Daytime dysfunction (reported mood, cognitive, social, or occupational impairment)
Exclusion criteria
* Age less than 65 * history of primary sleep disorder (e.g., sleep apnea, narcolepsy) * history of stroke * major medical illness known to contribute to sleep problems in last 12 months * cognitive impairment that interferes with ability to understand treatment (score \<23 on Mini-Mental State Examination)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up | from baseline to follow-up, approximately 1 year | Participants will complete a daily sleep dairies throughout the study period. They will report their bedtime, waketime, sleep onset latency, and wake time after sleep onset. Total sleep time and total wake time will be calculated from the diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in actigraphy-assessed sleep variability from baseline to follow-up | from baseline to follow-up, approximately 1 year | Participants wore an Actiwatch-L (ACTL) (Mini Mitter Co., Inc.) on their non-dominant wrists continuously throughout the study. The sensor of the ACTL is sampled 32 times per second and records peak values for each second. These peak values are then summed into 30-second "activity" counts. These activity counts are downloaded to a personal computer and analyzed using Actiware-Sleep v. 3.3, which uses a validated algorithm to identify periods of as sleep or wake. Total sleep time and total wake time will be computed. |
| Change in performance on the Mini-Mental Status Exam | from baseline to follow-up, approximately 1 year | Mini-Mental Status Exam (MMSE) (Folstein, Folstein, \& McHugh, 1975) |
| Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol | from baseline to follow-up, approximately 1 year | Wechsler Adult Intelligence Scale-3, Vocabulary \& Digit Symbol (subtests) \[WAIS-3\] |
| Change in performance on the Trails A & B (Reitan, 1958) | from baseline to follow-up, approximately 1 year | Trails A \& B (Reitan, 1958) was administered |
| Change in performance on the Controlled Oral Word Association | from baseline to follow-up, approximately 1 year | Controlled Oral Word Association (COWA) (Benton \& Hamsher, 1983) |
| Change in performance on the Boston Naming Test (BNT) | from baseline to follow-up, approximately 1 year | Boston Naming Test (BNT) |
| Change in performance on the California Verbal Learning Test (CVLT, CVLT-II) | from baseline to follow-up, approximately 1 year | California Verbal Learning Test (CVLT, CVLT-II) (Delis, Kramer, Kaplan, \& Ober, 1987) |
| Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002) | from baseline to follow-up, approximately 1 year | — |
| Change in performance on the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002) | from baseline to follow-up, approximately 1 year | — |
Contacts
PRINCIPAL_INVESTIGATORChristina McCrae, PhD
University of Missouri-Columbia
Outcome results
None listed