Back to resultsCurb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mantram Repetition
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for HIV Infections focused on measuring HIV, Randomized Trial, Stress, Spirituality, Quality of Life, Complementary Therapies
Eligibility Criteria
Inclusion Criteria: HIV infected for at least 6 months Ability to read and write English Exclusion Criteria: Drug use within the past 6 months Cognitive impairment or dementia Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma Loss of family/loved one in past 3 months Started a relaxation therapy in past 3 months History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM) Acute infection in past month Change of HAART or drug regimen in past month
Sites / Locations
- VA San Diego Healthcare System
Outcomes
Primary Outcome Measures
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger
Secondary Outcome Measures
Spiritual Well-Being (FACIT-SpEx)
Quality of Life Enjoyment and Satisfaction
Ways of Coping
Urinary cortisol levels
Urinary catecholamines
Salivary cortisol levels
Full Information
NCT ID
NCT00057538
First Posted
April 4, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00057538
Brief Title
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Official Title
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of California, San Diego
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.
Detailed Description
It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Randomized Trial, Stress, Spirituality, Quality of Life, Complementary Therapies
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mantram Repetition
Primary Outcome Measure Information:
Title
Intrusive Thoughts
Title
Perceived Stress
Title
Trait Anxiety
Title
Trait Anger
Secondary Outcome Measure Information:
Title
Spiritual Well-Being (FACIT-SpEx)
Title
Quality of Life Enjoyment and Satisfaction
Title
Ways of Coping
Title
Urinary cortisol levels
Title
Urinary catecholamines
Title
Salivary cortisol levels
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV infected for at least 6 months
Ability to read and write English
Exclusion Criteria:
Drug use within the past 6 months
Cognitive impairment or dementia
Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
Loss of family/loved one in past 3 months
Started a relaxation therapy in past 3 months
History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)
Acute infection in past month
Change of HAART or drug regimen in past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill E. Bormann, PhD, RN
Organizational Affiliation
California San Diego Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.
Results Reference
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Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
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