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

NCT00177203 | Completed DMC

• 2 other identifiers: 0211155P01AG020677
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Sleep Disorders; Sleeplessness; Chronic Insomnia; Sleep Studies; Disorders of Initiating and Maintaining Sleep; Primary Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Interventions

Brief Behavioral Treatment of Insomnia or Information BEHAVIORAL

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.

Also known as: Information only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 21263078 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel J Buysse, M.D.

  University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)