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



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

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to determine the efficacy 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.
Details: It is well documented that living with HIV/AIDS is stressful, 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. A randomized trial will be conducted to compare 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 the patient is screened.
Eligibility:
Study Type:
  Interventional, Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 60

Location and Contact Information:

VA San Diego Healthcare System *Recruiting*
San Diego,  California,  92116
United States
Recruiting Pat  Bone 858-552-8585


Additional Information:
Study ID Numbers:
  1 R21 AT01159-01A1; 
Study Start Date: May 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057538

Other Hiv Infections Studies:
1. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV

2. Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC

3. Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults

4. Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

5. A Phase I Trial of Tecogalan sodium (DS-4152) Administered as an Infusion Every 21 Days

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

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