Depression NOSMeditationNCT01537679
Meditation to Reduce Caregiver Stress
A study testing Kirtan Kriya meditation and Relaxation in people with Depression NOS and Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Depression NOS, Major Depressive Disorder, Anxiety NOS
- What is being tested?
- Kirtan Kriya meditation and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregivers of relatives with dementia who present to the Alzheimer s Disease Center or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances. Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support, 45 years of age or older, in contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below.
- Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
- Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression.
- Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D).
- Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE).
Who cannot join
- Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
- Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; Congestive Heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery).
- Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3.
- Subjects reporting daily use of alcohol will be excluded.
- Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
The purpose of this study is to determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.
Read the detailed description
This is an 8-week study to determine if meditation or listening to a relaxation CD will be effective in reducing depressive symptoms and stress, and in improving memory and cognition of caregivers who perform a daily meditation for 12 minutes a day for 8 weeks compared to caregivers listening to a relaxation CD for 12 minutes a day for 8 weeks. A second purpose of this study is to examine the role of genetic and inflammatory markers in response to listening to a relaxation CD and meditation.
- Conditions
- Depression NOS, Major Depressive Disorder, Anxiety NOS
- Being tested
- Kirtan Kriya meditation, Relaxation
- Keywords
- Caregiver, meditation, relaxation, stress
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kirtan Kriya meditationBehavioural
Also called Kundalini yoga meditation
Meditation will be taught to 20 caregivers and supervised by Helen Lavretsky, M.D during their first visit. Meditation Kirtan Kriya will be performed for 12 minutes every day at the same time of the day for 8 weeks. Compliance will be monitored during visits and by daily diaries that will be reviewed at each visit.
RelaxationBehavioural
Also called Relaxation techniques
Participants in the relaxation group will be asked to relax in a quiet place with eyes closed while listening to the music on the relaxation CD for 12 minutes every day at the same time for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Intervention | Other | Not described Receives: Behavioral: Kirtan Kriya meditation |
| Relaxation Intervention | Other | Not described Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Measured: 8 weeks
Secondary outcomes (2)
Caregiver Burden Scale
Measured: Week 1 and 8
Connor-Davidson Resilience scale (CD-RISC)
Measured: Week 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression NOSStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Lavretsky, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537679
- Sponsor's protocol ID
- 10-000270; 09-03-086-01D
- Acronym
- Meditation
- Status last verified
- Nov 2016
- First submitted
- 10 Feb 2012
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation or Relaxation Used to Reduce Stress Response and Improve Cognitive Functioning in Older Family Dementia Caregivers
- ClinicalTrials.gov ID
- NCT01537679
- Acronym / sponsor ID
- Meditation / 10-000270; 09-03-086-01D
- Conditions
- Depression NOS, Major Depressive Disorder, Anxiety NOS
- Keywords
- Caregiver, meditation, relaxation, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Feb 2012 (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 determine whether meditation will reduce stress and depressive of adult caregivers of a person with dementia.
Detailed description
This is an 8-week study to determine if meditation or listening to a relaxation CD will be effective in reducing depressive symptoms and stress, and in improving memory and cognition of caregivers who perform a daily meditation for 12 minutes a day for 8 weeks compared to caregivers listening to a relaxation CD for 12 minutes a day for 8 weeks. A second purpose of this study is to examine the role of genetic and inflammatory markers in response to listening to a relaxation CD and meditation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Intervention | Other | Behavioral: Kirtan Kriya meditation |
| Relaxation Intervention | Other | Behavioral: Relaxation |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caregivers of relatives with dementia who present to the Alzheimer s Disease Center or other UCLA geriatric or memory clinics for evaluation of dementia, cognitive impairment and/or co-existing behavioral disturbances. Caregivers will be identified by the family member with dementia or the physician as the primary source of assistance and/or support, 45 years of age or older, in contact with the individual with dementia at least three times/week for no less than one year, and a relative of the care-recipient (i.e., spouse or adult child). This criteria will ensure that the caregivers had been affected by substantial chronic stress, and they will also meet criteria specified below.
- Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
- Caregivers enrolled in the trial could meet the DSM-IVR criteria for minor depression or depression not otherwise specified (NOS), but not for other diagnosis of unipolar or bipolar major depression.
- Score between 6 and 15 on the Hamilton Depression Rating Scale-24 item (HAM-D).
- Score of 26 or higher on the Folstein Mini-Mental State Examination (MMSE).
Key exclusion criteria (5 listed)
- Current diagnosis of unipolar major depression, schizophrenia, bipolar, psychotic disorders including psychotic depression or dementia, attention deficit or hyperactivity disorder, anxiety, and alcohol or drug dependence. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
- Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; Congestive Heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; recent head trauma with loss of consciousness; recent stroke with residual neurological symptoms; recent cancer with ongoing treatment, or any other medical conditions requiring weekly visits to PCP or pending surgery).
- Level of suicidal risk precludes safe treatment on an outpatient basis with Hamilton Depression rating scale item number 3 rated as = 3.
- Subjects reporting daily use of alcohol will be excluded.
- Diagnosis of amnestic MCI by the analyses of delayed verbal recall on the California Verbal Learning Scale that will be 1.5 SD below the age/education adjusted norms for the general population.
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 |
|---|---|---|
| Kirtan Kriya meditationAlso: Kundalini yoga meditationMeditation will be taught to 20 caregivers and supervised by Helen Lavretsky, M.D during their first visit. Meditation Kirtan Kriya will be performed for 12 minutes every day at the same time of the day for 8 weeks. Compliance will be monitored during visits and by daily diaries that will be reviewed at each visit. | Behavioural | Meditation Intervention |
| RelaxationAlso: Relaxation techniquesParticipants in the relaxation group will be asked to relax in a quiet place with eyes closed while listening to the music on the relaxation CD for 12 minutes every day at the same time for 8 weeks. | Behavioural | Relaxation Intervention |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: 8 weeks
2 secondary outcomes
Caregiver Burden Scale
Time frame: Week 1 and 8
Connor-Davidson Resilience scale (CD-RISC)
Time frame: Week 1 and 8
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 Nov 2016.
- Meditation to Reduce Caregiver StressLink provided by the sponsor.
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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.
Helen Lavretsky, 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 Kirtan Kriya meditation and Relaxation in people with Depression NOS and Major Depressive Disorder, 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 5 inclusion and 5 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 Nov 2016. 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?
Hamilton Depression Rating Scale (HDRS) (time frame: 8 weeks). 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 28 Nov 2016.