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OpenTrials
Completed

NCT Number: NCT00057538

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mantram Repetition

Behavioral

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

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

  • University of California, San Diego

Registry information

Important dates

Study start
2003
Study completion
2003
First posted
Apr 7, 2003
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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