AgingNCT00280020
Behavioral Treatment of Insomnia in Aging
A study testing Tai Chi Chih (TCC), Cognitive Behavior Therapy (CBT) and Sleep Seminar (SS) in people with Aging and Insomnia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine activity. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- What is being tested?
- Tai Chi Chih (TCC), Cognitive Behavior Therapy (CBT) and Sleep Seminar (SS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Aug 2011
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 55 years of age at time of entry
- Sleep-onset delay, maintenance insomnia, or terminal insomnia
- Difficulties with sleep for a minimum of 3 nights per week
- Insomnia duration of at least 6 months
- Complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) attributed to insomnia
- Habitual sleep-wake schedule reporting "lights-out" between 9:00 PM and midnight
- Accessible geographically
Who cannot join
- Evidence that insomnia is directly related to a medical disorder (e.g., hyperthyroidism) or effects of a medication that affects sleep structure and/or immune functioning
- Presence of sleep apnea or periodic limb movements during sleep
- Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
- Regular use of a hypnotic or psychotropic medication (sleeping pills) and/or current psychotherapy or other behavioral therapy that would confound CBT or TCC
- Current history of a major psychiatric disorder (e.g. current major depression, alcohol or substance dependence, anxiety disorder)
- Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State examination
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- Abnormal screening laboratory tests (e.g., abnormal thyroid hormone, elevated TSH, positive screening for HIV or hepatitis C)
- Smokers will also be excluded because of potential confounding effects on markers of inflammation
- Body mass index that is greater than 30 kg/m2 as obesity is associated with excessive levels of inflammatory markers
- Women must be post-menopausal
- Unable to commit to intervention schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, 90095
About this study
Official title: Aging: Cytokine Mechanisms and Treatment of Insomnia
The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine activity.
Read the detailed description
Insomnia is a prominent complaint in late-life. However, little scientific effort has been directed toward identifying the biological mechanisms that are related to abnormal sleep or to evaluating the efficacy of behavioral treatments for insomnia in older adults. Basic observations demonstrate that proinflammatory cytokines play a key role in the regulation of sleep. Previous research shows that cytokines are reciprocally linked with abnormal sleep. This trial builds upon these findings and extends a program of study that has examined the efficacy of behavioral interventions on health outcomes in the elderly.
Preliminary studies found that Tai Chi Chih (TCC), a slow moving meditation, contributes to improvements in subjective sleep quality, sleep amounts and sleep efficiency, alterations in sympathetic activity, decreases in proinflammatory cytokines, and improvements in health functioning in community-dwelling older adults. Additionally, cognitive behavior therapy (CBT) confers benefits on sleep outcomes.
In this randomized, controlled trial, 150 older adults will be randomly assigned to CBT, TCC, or sleep hygiene/education control (EC) over 16 weeks and followed for one year. The aims of this project are to: 1) evaluate the effects of CBT vs TCC vs. EC on objective and subjective measures of sleep and on fatigue, mood, and health functioning in older adults with insomnia; 2) determine the effects of CBT vs.TCC vs. EC on measures of proinflammatory cytokine activity and sympathovagal balance, and whether these two biological mechanisms are related to changes of disordered sleep over the course of the treatment trial; and 3) evaluate whether circulating levels of proinflammatory cytokines are associated with measures of sleep continuity in older adults with insomnia over the treatment trial. This study will advance psychobiological models of disordered sleep and the potential benefits of two readily exportable behavioral interventions for promoting improvements in sleep outcomes in the elderly.
- Being tested
- Tai Chi Chih (TCC), Cognitive Behavior Therapy (CBT), Sleep Seminar (SS)
- Keywords
- sleep disorders, meditation, cognitive behavior therapy
- 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.
Tai Chi Chih (TCC)Behavioural
Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks
Cognitive Behavior Therapy (CBT)Behavioural
For each 2-hour session held once a week for 16 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
Sleep Seminar (SS)Behavioural
Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavior Therapy (CBT) |
| TCC | Experimental | Not described Receives: Behavioral: Tai Chi Chih (TCC) |
| SS | Active comparator | Not described Receives: Behavioral: Sleep Seminar (SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insomnia symptoms as measured by subjective report and objective polysomnography
Measured: Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks
Secondary outcomes (6)
Changes in measures of proinflammatory cytokine activity.
Measured: Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks
Change in daytime impairment secondary to insomnia
Measured: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in fatigue, depression and mood, and health function
Measured: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in sympathovagal function and energy balance
Measured: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in measures of interpersonal resilience and social
Measured: Baseline, 8, 12, 16 weeks, 3 months 1 year
Allostatic load
CBC, glucose, HbA1c, lipids, fibrinogen, measures of inflammation
Measured: baseline, post-treatment, and one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Irwin, M.D., University of California, Los Angeles
- Investigators
- Michael R. Irwin, MD, Principal investigator, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280020
- Sponsor's protocol ID
- AG0061
- Other IDs
- R01AG026364
- Status last verified
- Jul 2012
- First submitted
- 18 Jan 2006
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Irwin M, Pike J, Oxman M. Shingles Immunity and Health Functioning in the Elderly: Tai Chi Chih as a Behavioral Treatment. Evid Based Complement Alternat Med. 2004 Dec;1(3):223-232. doi: 10.1093/ecam/neh048. Epub 2004 Dec 1.
PubMed 15841255Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f.
PubMed 14508027Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94. doi: 10.1097/01.psy.0000149259.72488.09.
PubMed 15784782Lee SM, Te S, Breen EC, Olmstead R, Irwin MR, Cho JH. Circulating versus lipopolysaccharide-induced inflammatory markers as correlates of subthreshold depressive symptoms in older adults. World J Biol Psychiatry. 2020 Oct;21(8):634-641. doi: 10.1080/15622975.2019.1671608. Epub 2019 Oct 9.
PubMed 31552779Carroll JE, Seeman TE, Olmstead R, Melendez G, Sadakane R, Bootzin R, Nicassio P, Irwin MR. Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial. Psychoneuroendocrinology. 2015 May;55:184-92. doi: 10.1016/j.psyneuen.2015.02.010. Epub 2015 Feb 25.
PubMed 25770704Irwin MR, Olmstead R, Breen EC, Witarama T, Carrillo C, Sadeghi N, Arevalo JM, Ma J, Nicassio P, Bootzin R, Cole S. Cognitive behavioral therapy and tai chi reverse cellular and genomic markers of inflammation in late-life insomnia: a randomized controlled trial. Biol Psychiatry. 2015 Nov 15;78(10):721-9. doi: 10.1016/j.biopsych.2015.01.010. Epub 2015 Feb 4.
PubMed 25748580Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. Sleep. 2014 Sep 1;37(9):1543-52. doi: 10.5665/sleep.4008.
PubMed 25142571
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging: Cytokine Mechanisms and Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT00280020
- Acronym / sponsor ID
- AG0061
- Keywords
- sleep disorders, meditation, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Jan 2006 (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.
The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the study is to determine whether the behavioral treatment of insomnia alters proinflammatory cytokine activity.
Detailed description
Insomnia is a prominent complaint in late-life. However, little scientific effort has been directed toward identifying the biological mechanisms that are related to abnormal sleep or to evaluating the efficacy of behavioral treatments for insomnia in older adults. Basic observations demonstrate that proinflammatory cytokines play a key role in the regulation of sleep. Previous research shows that cytokines are reciprocally linked with abnormal sleep. This trial builds upon these findings and extends a program of study that has examined the efficacy of behavioral interventions on health outcomes in the elderly.
Preliminary studies found that Tai Chi Chih (TCC), a slow moving meditation, contributes to improvements in subjective sleep quality, sleep amounts and sleep efficiency, alterations in sympathetic activity, decreases in proinflammatory cytokines, and improvements in health functioning in community-dwelling older adults. Additionally, cognitive behavior therapy (CBT) confers benefits on sleep outcomes.
In this randomized, controlled trial, 150 older adults will be randomly assigned to CBT, TCC, or sleep hygiene/education control (EC) over 16 weeks and followed for one year. The aims of this project are to: 1) evaluate the effects of CBT vs TCC vs. EC on objective and subjective measures of sleep and on fatigue, mood, and health functioning in older adults with insomnia; 2) determine the effects of CBT vs.TCC vs. EC on measures of proinflammatory cytokine activity and sympathovagal balance, and whether these two biological mechanisms are related to changes of disordered sleep over the course of the treatment trial; and 3) evaluate whether circulating levels of proinflammatory cytokines are associated with measures of sleep continuity in older adults with insomnia over the treatment trial. This study will advance psychobiological models of disordered sleep and the potential benefits of two readily exportable behavioral interventions for promoting improvements in sleep outcomes in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavior Therapy (CBT) |
| TCC | Experimental | Behavioral: Tai Chi Chih (TCC) |
| SS | Active comparator | Behavioral: Sleep Seminar (SS) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 55 years of age at time of entry
- Sleep-onset delay, maintenance insomnia, or terminal insomnia
- Difficulties with sleep for a minimum of 3 nights per week
- Insomnia duration of at least 6 months
- Complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) attributed to insomnia
Key exclusion criteria (11 listed)
- Evidence that insomnia is directly related to a medical disorder (e.g., hyperthyroidism) or effects of a medication that affects sleep structure and/or immune functioning
- Presence of sleep apnea or periodic limb movements during sleep
- Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
- Regular use of a hypnotic or psychotropic medication (sleeping pills) and/or current psychotherapy or other behavioral therapy that would confound CBT or TCC
- Current history of a major psychiatric disorder (e.g. current major depression, alcohol or substance dependence, anxiety disorder)
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 |
|---|---|---|
| Tai Chi Chih (TCC)Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks | Behavioural | TCC |
| Cognitive Behavior Therapy (CBT)For each 2-hour session held once a week for 16 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application. | Behavioural | CBT |
| Sleep Seminar (SS)Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion. | Behavioural | SS |
Primary outcome
Changes in insomnia symptoms as measured by subjective report and objective polysomnography
Time frame: Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks
6 secondary outcomes
Changes in measures of proinflammatory cytokine activity.
Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year (single samples); repeated blood sampling during PSG nights for circadian cytokine activity: Baseline, 16 weeks
Change in daytime impairment secondary to insomnia
Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in fatigue, depression and mood, and health function
Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in sympathovagal function and energy balance
Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Changes in measures of interpersonal resilience and social
Time frame: Baseline, 8, 12, 16 weeks, 3 months 1 year
Allostatic load
Time frame: baseline, post-treatment, and one year follow-up
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 11 Jul 2012.
- Background: PubMed 15841255Irwin M, Pike J, Oxman M. Shingles Immunity and Health Functioning in the Elderly: Tai Chi Chih as a Behavioral Treatment. Evid Based Complement Alternat Med. 2004 Dec;1(3):223-232. doi: 10.1093/ecam/neh048. Epub 2004 Dec 1.
- Background: PubMed 14508027Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f.
- Background: PubMed 15784782Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94. doi: 10.1097/01.psy.0000149259.72488.09.
- Derived from this study: PubMed 31552779Lee SM, Te S, Breen EC, Olmstead R, Irwin MR, Cho JH. Circulating versus lipopolysaccharide-induced inflammatory markers as correlates of subthreshold depressive symptoms in older adults. World J Biol Psychiatry. 2020 Oct;21(8):634-641. doi: 10.1080/15622975.2019.1671608. Epub 2019 Oct 9.
- Derived from this study: PubMed 25770704Carroll JE, Seeman TE, Olmstead R, Melendez G, Sadakane R, Bootzin R, Nicassio P, Irwin MR. Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial. Psychoneuroendocrinology. 2015 May;55:184-92. doi: 10.1016/j.psyneuen.2015.02.010. Epub 2015 Feb 25.
- Derived from this study: PubMed 25748580Irwin MR, Olmstead R, Breen EC, Witarama T, Carrillo C, Sadeghi N, Arevalo JM, Ma J, Nicassio P, Bootzin R, Cole S. Cognitive behavioral therapy and tai chi reverse cellular and genomic markers of inflammation in late-life insomnia: a randomized controlled trial. Biol Psychiatry. 2015 Nov 15;78(10):721-9. doi: 10.1016/j.biopsych.2015.01.010. Epub 2015 Feb 4.
- Derived from this study: PubMed 25142571Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. Sleep. 2014 Sep 1;37(9):1543-52. doi: 10.5665/sleep.4008.
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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.
Michael R. Irwin, MD principal investigator
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Chih (TCC), Cognitive Behavior Therapy (CBT) and Sleep Seminar (SS) in people with Aging and Insomnia, run by University of California, Los Angeles 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 7 inclusion and 11 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 11 Jul 2012. 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?
Changes in insomnia symptoms as measured by subjective report and objective polysomnography (time frame: Subjective report: Baseline, 8, 12, 16 weeks, 3 months 1 year; PSG: Baseline, 16 weeks). 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 NCT00280020, which also lists 7 linked publications.
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 11 Jul 2012.