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Alternative Stress Management Approaches in HIV Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00029237
First Posted: January 10, 2002
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  Purpose
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.

Condition Intervention Phase
HIV Infections Behavioral: Cognitive-behavioral relaxation (Positively Living) Behavioral: Spiritual growth group Behavioral: Focused Tai Chi Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Alternative Stress Management Approaches in HIV Disease

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 392
Study Start Date: September 2000
Estimated Study Completion Date: May 2005
Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aware of HIV-infected diagnosis

Exclusion Criteria:

  • Current psychoactive drug use
  • Severe and unstable psychiatric diagnosis
  • Major cognitive dysfunction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029237


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0567
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
  More Information

ClinicalTrials.gov Identifier: NCT00029237     History of Changes
Other Study ID Numbers: R01AT000331 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2002
First Posted: January 10, 2002
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Behavioral intervention
Psychoneuroimmunology
Complementary therapy
Stress and coping
complementary therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases