Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care

Study Overview
=================
Brief Summary
-----------------
This project will test the efficacy of a brief, 2 session behavioral intervention for insomnia, as compared to an information-only condition. We hypothesize that compared to those receiving the information-only intervention, those assigned to BBTI will have superior short-term outcomes and retain the gains made, at 12 months. We will also compare older insomniacs to age matched good sleepers through measurers of mental and physical health, sleep, and general functioning. We hypothesize that the insomnia cohort will have more physical and mental health disorders of a greater severity than the age-matched controls.

Detailed Description
-----------------
As a prevalent problem among the elderly, insomnia is often treated by primary care physicians, and benzodiazepine receptor agonists (BzRA) are the most widely prescribed form of treatment. Behavioral interventions offer an effective option to BzRA therapy as they are preferred by many elderly patients and have a lower side effect profile. Presently behavioral interventions are available on specialty care clinics, provided by trained therapists, requiring up to six intervention sessions. This project will test the efficacy of a brief, two sessions behavioral model which could be adapted to the primary care setting. In addition, we will compare older insomniacs to age matched good sleepers through measurers of mental and physical health, sleep and general functioning. We expect that 100 enrolled individuals age 60 or older with Insomnia and a control cohort of 50 enrolled individuals matched by age and gender will complete the study. Subjects will be randomly assigned to one of two intervention conditions: (1.) receive a two session Brief Behavioral Treatment Intervention(BBTI), or (2.) a information-only modality in which they will be encouraged to read handouts on sleep, insomnia and healthy sleep practices published by the AASM. Clinical evaluation will include the Agebat measures (common to all five projects in this Program Project) and in-home or laboratory polysomnographic measures. Sleep dairies and wrist actigraphy will be used to measure treatment adherence. Patients will be evaluated before and after completing the assigned intervention cells. Those receiving BBTI will be re-evaluated at 12 months following a six month booster session. Data obtained from the control cohort will include the Agebat measures. We hypothesize that compared to those receiving the information-only intervention, those assigned to BBTI will have superior short-term outcomes and retain the gains made, at 12 months. We also predict that the insomnia cohort will have more physical and mental health disorders of a greater severity than the age-matched controls.

Official Title
-----------------
Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: Brief Behavioral Treatment of Insomnia or Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60 or older Current diagnosis of Insomnia using DSM-IV criteria (Insomnia group) No current diagnosis of Insomnia (Control group) Provision of written informed consent Exclusion Criteria: Psychiatric: untreated depressive, anxiety, psychotic and substance use disorders and/or treated or untreated delirium of dementia. We will exclude at intake to the study any individual with moderate to severe cognitive impairment who is likely to be demented. In the event that an individual scores less than < 25 on the Mini-Mental State Exam, we will exclude that person from the study. We will also discuss our concerns with the subject and will suggest that he or she contact the Memory Disorders Clinic run by the Alzheimer's Disease Research Center. We will give the subject literature on this Clinic as well as their phone number. We will not exclude persons with milder cognitive decrements because chronic medical disease and its associated sleep disruption are themselves associated with some impairment of cognitive performance. Medical: ongoing chemotherapy or radiation cancer treatment, hospitalization within the past two weeks or terminal illness with a life expectancy less than 6 months; Sleep: untreated obstructive sleep apnea syndrome, narcolepsy or restless legs syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Brief Behavioral Treatment of Insomnia or Information|The behavioral treatment involves education about sleep and its disorders; habits that help and hurt sleep; and recommendations about sleep hours and time in bed. It involves two meetings with a nurse who is part of the research team. In the information condition, participants are given similar information in printed brochures that are published by the American Academy of Sleep Medicine. They are instructed to read the information.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term outcome will be assessed by administration of the AgeWise battery of assessments (Agebat) and polysomnographic evaluations pre and post intervention. |  | Short-term outcome is assessed 4 weeks after intervention begins. | 
| Durability of BBTI will be evaluated by readministration of the clinical portions of the Agebat at six months, and both the clinical and polysomnographic evaluations at twelve months. |  | 6 months and 12 months after the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will evaluate the effects of physical and mental health on sleep during the initial evaluation. We will also determine how physical and mental health affects response to the specific sleep interventions at week 4, and 6 and 12 months. |  | Week 4, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Sleep Disorders, Sleeplessness, Chronic Insomnia, Sleep Studies, Disorders of Initiating and Maintaining Sleep, Primary Care