Clinical Trials Directory

Trials / Completed

CompletedNCT00029237

Alternative Stress Management Approaches in HIV Disease

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
392 (planned)
Sponsor
National Center for Complementary and Integrative Health (NCCIH) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive-behavioral relaxation (Positively Living)
BEHAVIORALSpiritual growth group
BEHAVIORALFocused Tai Chi

Timeline

Start date
2000-09-01
Completion
2005-05-01
First posted
2002-01-10
Last updated
2006-08-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00029237. Inclusion in this directory is not an endorsement.