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Alternative Stress Management Approaches in HIV Disease

Alternative Stress Management Approaches in HIV Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00029237
Enrollment
392
Registered
2002-01-10
Start date
2000-09-30
Completion date
2005-05-31
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Behavioral intervention, Psychoneuroimmunology, Complementary therapy, Stress and coping, complementary therapies

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).

Interventions

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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
ECT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aware of HIV-infected diagnosis

Exclusion criteria

* Current psychoactive drug use * Severe and unstable psychiatric diagnosis * Major cognitive dysfunction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026