Insomnia ChronicCARESNCT03538574
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers
A study testing CBT-I and MAP-I in people with Insomnia Chronic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- CBT-I and MAP-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Sep 2022
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer or other dementia caregivers
- Older than 45 years of age
- Self-identified as the principal person taking care of the patient with Alzheimer or other dementia
- Diagnostic and Statistical Manual Criteria - 5 for Insomnia
Who cannot join
- Psychiatric disorders including current major depressive disorder or other current DSM-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder;
- Psychotic symptoms;
- Acute suicidal or violent behavior or history of suicide attempt within the last year
- Other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by SCID-5 and Duke Structured Interview for Sleep Disorders (DSISD)
- Medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, Class III heart failure, inflammatory disorder)
- Chronic infections
Show all 12Show fewer
- Obesity with body mass index (BMI) >35
- Use of hormone containing medications including steroids or immune modifying drugs
- Daily use of analgesics such as opioids;
- Daily us of sedative hypnotic medications
- Cognitive impairment as evidenced by DSM-5 interview and/or Mini-Mental Status Exam (MMSE < 26)
- Actively practicing a mind body intervention.
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: Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms
Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. This is the first intervention trial in AD caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging
Read the detailed description
This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific aims of this project are:
Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective dimensions of insomnia.
Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of inflammation.
Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.
Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity Inventory, STRAIN, number \& experienced intensity of stress exposure) on insomnia outcomes, and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.
- Conditions
- Insomnia Chronic
- Being tested
- CBT-I, MAP-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
CBT-I is a behavioral treatment for insomnia
MAP-IBehavioural
MAP-I is a mindfulness meditation treatment for insomnia
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Cognitive behavioral therapy for insomnia (CBT-I), considered the treatment of choice by the American Academy of Sleep Medicine, combines cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation to improve sleep outcomes, with demonstrated efficacy in adult and older adult populations Receives: Behavioral: CBT-I |
| MAP-I | Experimental | The Mindful Awareness Practices (MAPs) is a validated and curriculum-based meditation similar to Mindfulness Based Stress Reduction, with the exception that MAPs does not include a day-long retreat or yoga and hence takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life. (http://marc.ucla.edu) MAP for Insomnia (MAP-I) is a modified version of MAPs that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan. Receives: Behavioral: MAP-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia clinical response
Change in severity of insomnia as measured by the Insomnia Severity Index
Measured: One-year
Secondary outcomes (4)
Insomnia clinical response
Change in severity of insomnia as measured by clinical diagnosis
Measured: One year
Daytime dysfunction
Change in depressed mood as measured by the Inventory of Depressive Symptoms
Measured: One year
Inflammation
Change in markers of systemic inflammation as measured by C-reactive protein
Measured: One year
Cellular aging
Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Model description
- Randomized, non-inferiority design
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Irwin, MD, University of California, Los Angeles
- Investigators
- Michael R Irwin, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538574
- Sponsor's protocol ID
- 16-001256
- Acronym
- CARES
- Status last verified
- Jun 2021
- First submitted
- 16 May 2018
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms
- ClinicalTrials.gov ID
- NCT03538574
- Acronym / sponsor ID
- CARES / 16-001256
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 May 2018 (actual)
- 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.
Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. This is the first intervention trial in AD caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging
Detailed description
This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific aims of this project are:
Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective dimensions of insomnia.
Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of inflammation.
Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.
Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity Inventory, STRAIN, number \& experienced intensity of stress exposure) on insomnia outcomes, and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, non-inferiority design
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: CBT-ICognitive behavioral therapy for insomnia (CBT-I), considered the treatment of choice by the American Academy of Sleep Medicine, combines cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation to improve sleep outcomes, with demonstrated efficacy in adult and older adult populations |
| MAP-I | Experimental | Behavioral: MAP-IThe Mindful Awareness Practices (MAPs) is a validated and curriculum-based meditation similar to Mindfulness Based Stress Reduction, with the exception that MAPs does not include a day-long retreat or yoga and hence takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life. (http://marc.ucla.edu) MAP for Insomnia (MAP-I) is a modified version of MAPs that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alzheimer or other dementia caregivers
- Older than 45 years of age
- Self-identified as the principal person taking care of the patient with Alzheimer or other dementia
- Diagnostic and Statistical Manual Criteria - 5 for Insomnia
Key exclusion criteria (12 listed)
- Psychiatric disorders including current major depressive disorder or other current DSM-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder;
- Psychotic symptoms;
- Acute suicidal or violent behavior or history of suicide attempt within the last year
- Other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by SCID-5 and Duke Structured Interview for Sleep Disorders (DSISD)
- Medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, Class III heart failure, inflammatory 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 |
|---|---|---|
| CBT-ICBT-I is a behavioral treatment for insomnia | Behavioural | CBT-I |
| MAP-IMAP-I is a mindfulness meditation treatment for insomnia | Behavioural | MAP-I |
Primary outcome
Insomnia clinical response
Time frame: One-year
Change in severity of insomnia as measured by the Insomnia Severity Index
4 secondary outcomes
Insomnia clinical response
Time frame: One year
Daytime dysfunction
Time frame: One year
Inflammation
Time frame: One year
Cellular aging
Time frame: One year
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 4 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and MAP-I in people with Insomnia Chronic, 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 4 inclusion and 12 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 4 Oct 2022. 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?
Insomnia clinical response (time frame: One-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.