NCT01527955

Brief Summary

The purpose of this study is to determine how effective Kelee meditation is in improving stress, anxiety, and depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

February 2, 2012

Last Update Submit

February 6, 2012

Conditions

Keywords

KeleeMeditationStressAnxietyDepressionBrainMind

Outcome Measures

Primary Outcomes (1)

  • 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.

    From Week 0 (baseline) to Week 12

Secondary Outcomes (8)

  • Change in Depression Subscale Score of DASS-42

    From Week 0 (baseline) to Week 12

  • Change in Anxiety Subscale Score of DASS-42

    From Week 0 (baseline) to Week 12

  • Change in Stress Subscale Score of DASS-42

    From Week 0 (baseline) to Week 12

  • Change in Total Score of Beck Depression Inventory-II (BDI-II)

    From Week 0 (baseline) to Week 12

  • Change in Total Score of Beck Anxiety Inventory (BAI)

    From Week 0 (baseline) to Week 12

  • +3 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English readers or speakers
  • Hearing-impaired
  • Low literacy below 5th grade reading and comprehension level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Being Alive San Diego

San Diego, California, 92103, United States

Location

University of California, San Diego Medical Center

San Diego, California, 92103, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Daniel Lee, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor of Medicine

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 7, 2012

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

June 1, 2011

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations