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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jill E. Bormann, PhD, RN, California San Diego Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

May 1, 2003

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 7, 2003

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 16, 2006

Last Verified

August 1, 2006

More Information

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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