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

Insomnia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

• NCT number: NCT00177203
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Completion date: January 2009