Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057538
Recruitment Status : Completed
First Posted : April 7, 2003
Last Update Posted : August 18, 2006
University of California, San Diego
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

April 4, 2003
April 7, 2003
August 18, 2006
May 2003
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  • Intrusive Thoughts
  • Perceived Stress
  • Trait Anxiety
  • Trait Anger
Not Provided
Complete list of historical versions of study NCT00057538 on Archive Site
  • Spiritual Well-Being (FACIT-SpEx)
  • Quality of Life Enjoyment and Satisfaction
  • Ways of Coping
  • Urinary cortisol levels
  • Urinary catecholamines
  • Salivary cortisol levels
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Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
HIV Infections
Behavioral: Mantram Repetition
Not Provided
Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2003
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT001159-01A1( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
Principal Investigator: Jill E. Bormann, PhD, RN California San Diego Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP