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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training
Official Title:	Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Anxiety HIV/AIDS

U.S. FDA Resources

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.

ClinicalTrials.gov Identifier:	NCT00057538 History of Changes
Other Study ID Numbers:	R21 AT001159-01A1
Study First Received:	April 4, 2003
Last Updated:	August 16, 2006
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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 13, 2012