Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care (AW3)

May 27, 2015 updated by: University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Insomnia

Intervention / Treatment

Behavioral: Brief Behavioral Treatment of Insomnia or Information

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Short-term outcome will be assessed by administration of the AgeWise battery of assessments (Agebat) and polysomnographic evaluations pre and post intervention. Time Frame: Short-term outcome is assessed 4 weeks after intervention begins.	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. Time Frame: 6 months and 12 months after the start of the intervention	6 months and 12 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure	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. Time Frame: Week 4, 6 months, 12 months	Week 4, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator: Daniel J Buysse, M.D., University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, Begley A, Houck PR, Mazumdar S, Reynolds CF 3rd, Monk TH. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011 May 23;171(10):887-95. doi: 10.1001/archinternmed.2010.535. Epub 2011 Jan 24. Erratum In: JAMA Intern Med. 2019 Aug 1;179(8):1152.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)