Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Mantram Repetition |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training |
| Official Title: | Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV |
- Intrusive Thoughts
- Perceived Stress
- Trait Anxiety
- Trait Anger
- Spiritual Well-Being (FACIT-SpEx)
- Quality of Life Enjoyment and Satisfaction
- Ways of Coping
- Urinary cortisol levels
- Urinary catecholamines
- Salivary cortisol levels
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | May 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00057538
| United States, California | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Jill E. Bormann, PhD, RN | California San Diego Healthcare System |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00057538 History of Changes |
| Other Study ID Numbers: | R21 AT001159-01A1 |
| Study First Received: | April 4, 2003 |
| Last Updated: | August 16, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
|
HIV Randomized Trial Stress |
Spirituality Quality of Life Complementary Therapies |
ClinicalTrials.gov processed this record on March 02, 2015