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

Purpose

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
HIV Infections	Behavioral: Mantram Repetition	Phase II

MedlinePlus related topics:

AIDS Stress

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

Estimated Enrollment:	60
Study Start Date:	May 2003
Estimated Study Completion Date:	May 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057538

Locations


United States, California
	VA San Diego Healthcare System
	San Diego, California, United States, 92161

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

University of California, San Diego

Investigators


Principal Investigator:	Jill E. Bormann, PhD, RN	California San Diego Healthcare System

More Information

Publications:

Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.

Study ID Numbers:	R21 AT001159-01A1
First Received:	April 4, 2003
Last Updated:	August 16, 2006
ClinicalTrials.gov Identifier:	NCT00057538
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

HIV

Randomized Trial

Stress

Spirituality

Quality of Life

Complementary Therapies

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Quality of Life

Stress

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) University of California, San Diego
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00057538