NCT00029237

Brief Summary

The overall purpose of the proposed study is to determine whether three short-term stress management interventions along with booster strategies will improve and sustain improvements in psychosocial functioning, quality of life, and somatic health among persons with varying stages of HIV disease. The 10-week group interventions are designed to reduce perceived stress and increase coping effectiveness and include cognitive-behavioral stress management focused on positively living (+LIVE), focused Tai Chi (TCHI) training, and spiritual growth groups (SPRT). Effects of the interventions will be evaluated immediately upon completion of the group training and at 6 months and 12 months following stress management training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Sep 2000

Typical duration for phase_3 hiv-infections

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

January 9, 2002

Last Update Submit

August 17, 2006

Conditions

HIV Infections

Keywords

Behavioral interventionPsychoneuroimmunologyComplementary therapyStress and copingcomplementary therapies

Interventions

Cognitive-behavioral relaxation (Positively Living)BEHAVIORAL
Spiritual growth groupBEHAVIORAL
Focused Tai ChiBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Aware of HIV-infected diagnosis

You may not qualify if:

  • Current psychoactive drug use
  • Severe and unstable psychiatric diagnosis
  • Major cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298-0567, United States

Location

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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

January 9, 2002

First Posted

January 10, 2002

Study Start

September 1, 2000

Study Completion

May 1, 2005

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)