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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057538
• Other study ID #: R21AT001159-01A1
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2003
• Last updated: August 16, 2006
• Start date: May 2003
• Est. completion date: May 2003

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Mantram Repetition

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrusive Thoughts
Primary	Perceived Stress
Primary	Trait Anxiety
Primary	Trait Anger
Secondary	Spiritual Well-Being (FACIT-SpEx)
Secondary	Quality of Life Enjoyment and Satisfaction
Secondary	Ways of Coping
Secondary	Urinary cortisol levels
Secondary	Urinary catecholamines
Secondary	Salivary cortisol levels