- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057538
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Study Overview
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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California
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San Diego, California, United States, 92161
- VA San Diego Healthcare System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Intrusive Thoughts
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Perceived Stress
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Trait Anxiety
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Trait Anger
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Secondary Outcome Measures
Outcome Measure |
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Urinary catecholamines
|
Spiritual Well-Being (FACIT-SpEx)
|
Quality of Life Enjoyment and Satisfaction
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Ways of Coping
|
Urinary cortisol levels
|
Salivary cortisol levels
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jill E. Bormann, PhD, RN, California San Diego Healthcare System
Publications and helpful links
General Publications
- Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001159-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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