StressNCT01527955
Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression
A study testing Kelee Meditation in people with Stress and Anxiety, run by University of California, San Diego at 2 sites in United States.
Trial summary
The purpose of this study is to determine how effective Kelee meditation is in improving stress, anxiety, and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Kelee Meditation
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV-1 infection
- Ages 18 to 65
- Experiencing some level of stress, anxiety, or depression
- No current use of other meditation practices or holistic modalities
Who cannot join
- Non-English readers or speakers
- Hearing-impaired
- Low literacy below 5th grade reading and comprehension level
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Being Alive San Diego
San Diego, California, 92103
University of California, San Diego Medical Center
San Diego, California, 92103
About this study
Official title: Troubleshooting the Mind Through Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression
The purpose of this study is to determine how effective Kelee meditation is in improving stress, anxiety, and depression.
Read the detailed description
The Kelee and Kelee meditation (KM) were developed and founded by Ron W. Rathbun. KM is a unique and distinctive form of meditation that is easy to learn and requires only about 10 minutes twice a day to perform. The goal and discipline of KM is the development of one-pointed stillness of mind. To better comprehend how KM is effective in reducing stress, anxiety, and depression, one must understand the difference between concentration and meditation, and the basic principles of the Kelee. Experiencing and understanding the distinction between brain function and mind function are of vital importance in KM. Brain function is associated with the tension-based, intellectual, thinking process and the five physical senses whereas mind function is associated with the relaxation-based, experiential, mental feeling process, self-awareness, and clear perception. Performing KM leads to the calming of brain function and opening to the experience of mind function. With continued practice, persistence, and patience, the practitioner can begin to learn on his own how to examine and understand (ie, troubleshoot) his own thoughts and feelings from a calm, clear internal space that is free from the negative chatter and preconception associated with the brain. This increases self-awareness of the presence of internalized compartments (misperceptions of life that exist as negative thoughts and/or feelings) and the practitioner begins to develop clarity of perception. Clear perception allows one to begin the process of detachment from internalized compartments, which occurs through the cessation of looping followed by the processing of compartments. As each negative compartment dissipates, the practitioner experiences a subtle, but cumulative, corresponding improvement in stress, anxiety, and depression. When the flow of the Kelee is allowed to be, there is balance between the thinking and the feeling process leading to overall well-being, which leads to improved self-efficacy and reinforces the repetition of KM.
- Conditions
- Stress, Anxiety, Depression
- Being tested
- Kelee Meditation
- Keywords
- Kelee, Meditation, Stress, Anxiety, Depression, Brain, Mind
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kelee MeditationOther
The participants were instructed on how to perform Kelee Meditation (KM) at the initial session. This was followed by a comprehensive review of the Kelee principles and reference points over the subsequent 12 weeks. At the beginning of each weekly session, a group meditation was performed, which was followed by individual introspection and contemplation. Participants recorded their observations and experiences in a KM journal. Each participant had the opportunity to share his own journal entry and to ask questions about his own observations and experiences since starting KM. Participants were encouraged to perform the KM practice 10 minutes twice daily throughout the 12 weeks of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score of Depression, Anxiety, and Stress Scales-42 (DASS-42)
The DASS is a set of 3 self-report scales designed to measure the negative emotional states of depression, anxiety and stress and to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress. Each of the 3 DASS scales contains 14 items. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items.
Measured: From Week 0 (baseline) to Week 12
Secondary outcomes (8)
Change in Depression Subscale Score of DASS-42
The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia.
Measured: From Week 0 (baseline) to Week 12
Change in Anxiety Subscale Score of DASS-42
The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.
Measured: From Week 0 (baseline) to Week 12
Change in Stress Subscale Score of DASS-42
The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient.
Measured: From Week 0 (baseline) to Week 12
Change in Total Score of Beck Depression Inventory-II (BDI-II)
The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. The cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: From Week 0 (baseline) to Week 12
Change in Total Score of Beck Anxiety Inventory (BAI)
The BAI consists of 21 questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety. Each answer is scored on a scale value of 0 to 3. The cutoffs are as follows: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; and 26-63: severe anxiety.
Measured: From Week 0 (baseline) to Week 12
Change in Total Score of Perceived Stress Scale-10 (PSS-10)
The Perceived Stress Scale (PSS) is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Higher total scores suggest a higher degree of perceived stress.
Measured: From Week 0 (baseline) to Week 12
Change in Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R)
The Symptom Checklist-90-R (SCL-90-R) instrument helps to evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The Global Severity Index (GSI) is the summary of the test and is designed to measure overall psychological distress.
Measured: From Week 0 (baseline) to Week 12
Change in Mental Component Summary (MCS) of the Short Form-36 Health Survey (SF-36)
The SF-36 is a short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures [Physical Component Summary (PCS) and Mental Component Summary (MCS)] and a preference-based health utility index.
Measured: From Week 0 (baseline) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lee, MD, University of California, San Diego
- Investigators
- Daniel Lee, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527955
- Sponsor's protocol ID
- IRB Project#081197
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troubleshooting the Mind Through Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT01527955
- Acronym / sponsor ID
- IRB Project#081197
- Conditions
- Stress, Anxiety, Depression
- Keywords
- Kelee, Meditation, Stress, Anxiety, Depression, Brain, Mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 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 how effective Kelee meditation is in improving stress, anxiety, and depression.
Detailed description
The Kelee and Kelee meditation (KM) were developed and founded by Ron W. Rathbun. KM is a unique and distinctive form of meditation that is easy to learn and requires only about 10 minutes twice a day to perform. The goal and discipline of KM is the development of one-pointed stillness of mind. To better comprehend how KM is effective in reducing stress, anxiety, and depression, one must understand the difference between concentration and meditation, and the basic principles of the Kelee. Experiencing and understanding the distinction between brain function and mind function are of vital importance in KM. Brain function is associated with the tension-based, intellectual, thinking process and the five physical senses whereas mind function is associated with the relaxation-based, experiential, mental feeling process, self-awareness, and clear perception. Performing KM leads to the calming of brain function and opening to the experience of mind function. With continued practice, persistence, and patience, the practitioner can begin to learn on his own how to examine and understand (ie, troubleshoot) his own thoughts and feelings from a calm, clear internal space that is free from the negative chatter and preconception associated with the brain. This increases self-awareness of the presence of internalized compartments (misperceptions of life that exist as negative thoughts and/or feelings) and the practitioner begins to develop clarity of perception. Clear perception allows one to begin the process of detachment from internalized compartments, which occurs through the cessation of looping followed by the processing of compartments. As each negative compartment dissipates, the practitioner experiences a subtle, but cumulative, corresponding improvement in stress, anxiety, and depression. When the flow of the Kelee is allowed to be, there is balance between the thinking and the feeling process leading to overall well-being, which leads to improved self-efficacy and reinforces the repetition of KM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV-1 infection
- Ages 18 to 65
- Experiencing some level of stress, anxiety, or depression
- No current use of other meditation practices or holistic modalities
Key exclusion criteria (3 listed)
- Non-English readers or speakers
- Hearing-impaired
- Low literacy below 5th grade reading and comprehension level
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 |
|---|---|---|
| Kelee MeditationThe participants were instructed on how to perform Kelee Meditation (KM) at the initial session. This was followed by a comprehensive review of the Kelee principles and reference points over the subsequent 12 weeks. At the beginning of each weekly session, a group meditation was performed, which was followed by individual introspection and contemplation. Participants recorded their observations and experiences in a KM journal. Each participant had the opportunity to share his own journal entry and to ask questions about his own observations and experiences since starting KM. Participants were encouraged to perform the KM practice 10 minutes twice daily throughout the 12 weeks of the study. | Other | – |
Primary outcome
Change in Total Score of Depression, Anxiety, and Stress Scales-42 (DASS-42)
Time frame: From Week 0 (baseline) to Week 12
The DASS is a set of 3 self-report scales designed to measure the negative emotional states of depression, anxiety and stress and to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress. Each of the 3 DASS scales contains 14 items. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items.
8 secondary outcomes
Change in Depression Subscale Score of DASS-42
Time frame: From Week 0 (baseline) to Week 12
Change in Anxiety Subscale Score of DASS-42
Time frame: From Week 0 (baseline) to Week 12
Change in Stress Subscale Score of DASS-42
Time frame: From Week 0 (baseline) to Week 12
Change in Total Score of Beck Depression Inventory-II (BDI-II)
Time frame: From Week 0 (baseline) to Week 12
Change in Total Score of Beck Anxiety Inventory (BAI)
Time frame: From Week 0 (baseline) to Week 12
Change in Total Score of Perceived Stress Scale-10 (PSS-10)
Time frame: From Week 0 (baseline) to Week 12
Change in Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R)
Time frame: From Week 0 (baseline) to Week 12
Change in Mental Component Summary (MCS) of the Short Form-36 Health Survey (SF-36)
Time frame: From Week 0 (baseline) to Week 12
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 7 Feb 2012.
- Kelee Foundation website for more information about Kelee MeditationLink 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.
Daniel Lee, MD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kelee Meditation in people with Stress and Anxiety, run by University of California, San Diego at 2 sites 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 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Total Score of Depression, Anxiety, and Stress Scales-42 (DASS-42) (time frame: From Week 0 (baseline) to Week 12). 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 7 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.