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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Mantram Repetition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mantram Repetition|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrusive Thoughts |  |  | 
| Perceived Stress |  |  | 
| Trait Anxiety |  |  | 
| Trait Anger |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spiritual Well-Being (FACIT-SpEx) |  |  | 
| Quality of Life Enjoyment and Satisfaction |  |  | 
| Ways of Coping |  |  | 
| Urinary cortisol levels |  |  | 
| Urinary catecholamines |  |  | 
| Salivary cortisol levels |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Randomized Trial, Stress, Spirituality, Quality of Life, Complementary Therapies