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Alternative Stress Management Approaches in HIV Disease

NCT ID: NCT00029237

Last Updated: 2006-08-18

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

PHASE3

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-05-31

Brief Summary

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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.

Detailed Description

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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 the domains of psychosocial functioning, quality of life, and somatic health among persons with varying stages of HIV disease. These three outcome domains, along with neuroendocrine mediation, will be measured by multiple indicators derived from the psychoneuroimmunology (PNI)paradigm. The 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). The primary aim of this randomized clinical trial is to compare the +LIVE, TCHI, and SPRT interventions to each other and to standard care received by a control group of wait-listed participants (WAIT) for effects on psychosocial functioning (perceived stress, coping patterns, social support, psychological distress), quality of life (including spiritual well-being), neuroendocrine mediation (cortisol, DHEA levels), and somatic health (disease progression, HIV-specific health status, immune status).

Conditions

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HIV Infections

Keywords

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Behavioral intervention Psychoneuroimmunology Complementary therapy Stress and coping complementary therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Cognitive-behavioral relaxation (Positively Living)

Intervention Type BEHAVIORAL

Spiritual growth group

Intervention Type BEHAVIORAL

Focused Tai Chi

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aware of HIV-infected diagnosis

Exclusion Criteria

* Current psychoactive drug use
* Severe and unstable psychiatric diagnosis
* Major cognitive dysfunction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT000331

Identifier Type: NIH

Identifier Source: org_study_id

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