Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression
|ClinicalTrials.gov Identifier: NCT01527955|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stress Anxiety Depression||Other: Kelee Meditation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Troubleshooting the Mind Through Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||June 2011|
Other: Kelee Meditation
- 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.
- Change in Depression Subscale Score of DASS-42 [ Time Frame: From Week 0 (baseline) to Week 12 ]The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia.
- Change in Anxiety Subscale Score of DASS-42 [ Time Frame: From Week 0 (baseline) to Week 12 ]The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.
- Change in Stress Subscale Score of DASS-42 [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
- Change in Total Score of Beck Depression Inventory-II (BDI-II) [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
- Change in Total Score of Beck Anxiety Inventory (BAI) [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
- Change in Total Score of Perceived Stress Scale-10 (PSS-10) [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
- Change in Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R) [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
- Change in Mental Component Summary (MCS) of the Short Form-36 Health Survey (SF-36) [ Time Frame: From Week 0 (baseline) to Week 12 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527955
|United States, California|
|Being Alive San Diego|
|San Diego, California, United States, 92103|
|University of California, San Diego Medical Center|
|San Diego, California, United States, 92103|
|Principal Investigator:||Daniel Lee, MD||University of California, San Diego|