CClinicalTrials.gg
CompletedNCT00057538Updated Aug 18, 2006

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

A Phase 2 interventional study of Mantram Repetition in HIV Infections, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-08-18.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2, Interventional, and Educational/counseling/training

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • HIV
  • Randomized Trial
  • Stress
  • Spirituality
  • Quality of Life
  • Complementary Therapies
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HIV infected for at least 6 months
  • Ability to read and write English

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
60 participants

Interventions

  • BehavioralMantram Repetition
06

What researchers measure

Primary outcomes

  1. Intrusive Thoughts

  2. Perceived Stress

  3. Trait Anxiety

  4. Trait Anger

Secondary outcomes

  1. Spiritual Well-Being (FACIT-SpEx)

  2. Quality of Life Enjoyment and Satisfaction

  3. Ways of Coping

  4. Urinary cortisol levels

  5. Urinary catecholamines

  6. Salivary cortisol levels

07

Study locations

1 site
  • VA San Diego Healthcare System
    San Diego, California 92161, United States
08

References and documents

Publications

  • Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00057538
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
University of California, San Diego
First posted
Apr 7, 2003
Start date
May 2003
Completion
May 2003
Last update
Aug 18, 2006

Study contacts

Jill E. Bormann, PhD, RN
principal investigator · California San Diego Healthcare System
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion