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

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ClinicalTrials.gov Identifier: NCT00057538
Recruitment Status : Completed
First Posted : April 7, 2003
Last Update Posted : August 18, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Mantram Repetition Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Study Start Date : May 2003
Estimated Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Intrusive Thoughts
  2. Perceived Stress
  3. Trait Anxiety
  4. Trait Anger

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057538


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
Investigators
Principal Investigator: Jill E. Bormann, PhD, RN California San Diego Healthcare System
More Information

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

ClinicalTrials.gov Identifier: NCT00057538     History of Changes
Other Study ID Numbers: R21AT001159-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2003    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
HIV
Randomized Trial
Stress
Spirituality
Quality of Life
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases