InsomniaAW3NCT00177203
Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care
A study testing Brief Behavioral Treatment of Insomnia or Information in people with Insomnia, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Brief Behavioral Treatment of Insomnia or Information
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Brief Behavioral Treatment of Insomnia or Information
- Keywords
- Insomnia, Sleep Disorders, Sleeplessness, Chronic Insomnia, Sleep Studies, Disorders of Initiating and Maintaining Sleep, Primary Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment of Insomnia or InformationBehavioural
Also called Information only
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 being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome will be assessed by administration of the AgeWise battery of assessments (Agebat) and polysomnographic evaluations pre and post intervention.
Measured: 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.
Measured: 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.
Measured: Week 4, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Daniel J Buysse, M.D., Principal investigator, University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177203
- Sponsor's protocol ID
- 021115
- Other IDs
- 5P01AG020677
- Acronym
- AW3
- Status last verified
- May 2015
- First submitted
- 12 Sep 2005
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21263078
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agewise Project 3: Brief Behavioral Treatment of Insomnia in Primary Care
- ClinicalTrials.gov ID
- NCT00177203
- Acronym / sponsor ID
- AW3 / 021115
- Conditions
- Insomnia
- Keywords
- Insomnia, Sleep Disorders, Sleeplessness, Chronic Insomnia, Sleep Studies, Disorders of Initiating and Maintaining Sleep, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Treatment of Insomnia or InformationAlso: Information onlyThe 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. | Behavioural | – |
Primary outcome
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.
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 21263078Buysse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Buysse, M.D. principal investigator
University of Pittsburgh Medical Center, Western Psychiatric Institute & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment of Insomnia or Information in people with Insomnia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00177203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.