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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:
Exclusion Criteria:
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| 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 |
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