Clinical Trials Directory

Trials / Completed

CompletedNCT00057538

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (planned)
Sponsor
National Center for Complementary and Integrative Health (NCCIH) · NIH
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMantram Repetition

Timeline

Start date
2003-05-01
Completion
2003-05-01
First posted
2003-04-07
Last updated
2006-08-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00057538. Inclusion in this directory is not an endorsement.