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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00057538
First received: April 4, 2003
Last updated: August 16, 2006
Last verified: August 2006
History of Changes

April 4, 2003
August 16, 2006
May 2003
Not Provided
  • Intrusive Thoughts
  • Perceived Stress
  • Trait Anxiety
  • Trait Anger
Not Provided
Complete list of historical versions of study NCT00057538 on ClinicalTrials.gov Archive Site
  • Spiritual Well-Being (FACIT-SpEx)
  • Quality of Life Enjoyment and Satisfaction
  • Ways of Coping
  • Urinary cortisol levels
  • Urinary catecholamines
  • Salivary cortisol levels
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2003
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057538
R21 AT001159-01A1
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
University of California, San Diego
Principal Investigator: Jill E. Bormann, PhD, RN California San Diego Healthcare System
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

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