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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) University of California, San Diego |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00057538 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Behavioral: Mantram Repetition |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV |
Estimated Enrollment: | 60 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | May 2003 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92161 |
Principal Investigator: | Jill E. Bormann, PhD, RN | California San Diego Healthcare System |
Study ID Numbers: | R21 AT001159-01A1 |
Study First Received: | April 4, 2003 |
Last Updated: | August 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00057538 |
Health Authority: | United States: Federal Government |
HIV Randomized Trial Stress |
Spirituality Quality of Life Complementary Therapies |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Quality of Life Stress Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |