NCT00057538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

April 4, 2003

Last Update Submit

August 16, 2006

Conditions

HIV Infections

Keywords

HIVRandomized TrialStressSpiritualityQuality of LifeComplementary Therapies

Outcome Measures

Primary Outcomes (4)

  • Intrusive Thoughts

  • Perceived Stress

  • Trait Anxiety

  • Trait Anger

Secondary Outcomes (6)

  • Spiritual Well-Being (FACIT-SpEx)

  • Quality of Life Enjoyment and Satisfaction

  • Ways of Coping

  • Urinary cortisol levels

  • Urinary catecholamines

  • +1 more secondary outcomes

Interventions

Mantram RepetitionBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected for at least 6 months
  • Ability to read and write English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jill E. Bormann, PhD, RN

    California San Diego Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

May 1, 2003

Study Completion

May 1, 2003

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)