Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057538
Enrollment
60
Registered
2003-04-07
Start date
2003-05-31
Completion date
2003-05-31
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Randomized Trial, Stress, Spirituality, Quality of Life, Complementary Therapies

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.

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.

Interventions

BEHAVIORALMantram Repetition

Sponsors

University of California, San Diego
CollaboratorOTHER
National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger

Secondary

MeasureTime frame
Urinary catecholamines
Spiritual Well-Being (FACIT-SpEx)
Salivary cortisol levels
Quality of Life Enjoyment and Satisfaction
Ways of Coping
Urinary cortisol levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026