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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Behavioral: Mantram Repetition

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00057538

R21AT001159-01A1

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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