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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2003-05-31

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.

Conditions

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HIV Infections

Keywords

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HIV Randomized Trial Stress Spirituality Quality of Life Complementary Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

SINGLE

Interventions

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Mantram Repetition

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jill E. Bormann, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

California San Diego Healthcare System

Locations

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VA San Diego Healthcare System

San Diego, California, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

Other Identifiers

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R21AT001159-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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