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

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00057538

Collaborator

University of California, San Diego (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Mantram Repetition	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Educational/Counseling/Training

Official Title:

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

Study Start Date :

May 1, 2003

Study Completion Date :

May 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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