Alternative Stress Management Approaches in HIV Disease

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00029237
First received: January 9, 2002
Last updated: August 17, 2006
Last verified: August 2006

January 9, 2002
August 17, 2006
September 2000
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Complete list of historical versions of study NCT00029237 on ClinicalTrials.gov Archive Site
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Alternative Stress Management Approaches in HIV Disease
Alternative Stress Management Approaches in HIV Disease

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
HIV Infections
  • Behavioral: Cognitive-behavioral relaxation (Positively Living)
  • Behavioral: Spiritual growth group
  • Behavioral: Focused Tai Chi
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
May 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029237
R01 AT000331
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National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
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National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP