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Alternative Stress Management Approaches in HIV Disease

This study has been completed.
Study NCT00029237.   Last updated on August 17, 2006.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Alternative Stress Management Approaches in HIV Disease
Official Title  Alternative Stress Management Approaches in HIV Disease
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.

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).

Study Phase Phase III
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Behavioral: Cognitive-behavioral relaxation (Positively Living)
Behavioral: Spiritual growth group
Behavioral: Focused Tai Chi
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  392
Start Date  September 2000
Completion Date May 2005
Eligibility Criteria 

Inclusion Criteria:

  • Aware of HIV-infected diagnosis

Exclusion Criteria:

  • Current psychoactive drug use
  • Severe and unstable psychiatric diagnosis
  • Major cognitive dysfunction
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00029237
Organization ID R01 AT000331
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  January 9, 2002
Last Updated Date August 17, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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