Alternative Stress Management Approaches in HIV Disease
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral relaxation (Positively Living)
Spiritual growth group
Focused Tai Chi
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for HIV Infections focused on measuring Behavioral intervention, Psychoneuroimmunology, Complementary therapy, Stress and coping, complementary therapies
Eligibility Criteria
Inclusion Criteria: Aware of HIV-infected diagnosis Exclusion Criteria: Current psychoactive drug use Severe and unstable psychiatric diagnosis Major cognitive dysfunction
Sites / Locations
- Virginia Commonwealth University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00029237
First Posted
January 9, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00029237
Brief Title
Alternative Stress Management Approaches in HIV Disease
Official Title
Alternative Stress Management Approaches in HIV Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Behavioral intervention, Psychoneuroimmunology, Complementary therapy, Stress and coping, complementary therapies
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral relaxation (Positively Living)
Intervention Type
Behavioral
Intervention Name(s)
Spiritual growth group
Intervention Type
Behavioral
Intervention Name(s)
Focused Tai Chi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aware of HIV-infected diagnosis
Exclusion Criteria:
Current psychoactive drug use
Severe and unstable psychiatric diagnosis
Major cognitive dysfunction
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0567
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alternative Stress Management Approaches in HIV Disease
We'll reach out to this number within 24 hrs