HIV InfectionsPhase 3NCT00029237
Alternative Stress Management Approaches in HIV Disease
A Phase 3 study testing Cognitive-behavioral relaxation (Positively Living), Spiritual growth group and Focused Tai Chi in people with HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cognitive-behavioral relaxation (Positively Living), Spiritual growth group and Focused Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aware of HIV-infected diagnosis
Who cannot join
- Current psychoactive drug use
- Severe and unstable psychiatric diagnosis
- Major cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298-0567
About this study
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.
Read the 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
- HIV Infections
- Being tested
- Cognitive-behavioral relaxation (Positively Living), Spiritual growth group, Focused Tai Chi
- Keywords
- Behavioral intervention, Psychoneuroimmunology, Complementary therapy, Stress and coping, complementary therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral relaxation (Positively Living)Behavioural
Spiritual growth groupBehavioural
Focused Tai ChiBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2002 (estimated)
- Study startSep 2000
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 392 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029237
- Sponsor's protocol ID
- R01AT000331
- Status last verified
- Aug 2006
- First submitted
- 9 Jan 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Stress Management Approaches in HIV Disease
- ClinicalTrials.gov ID
- NCT00029237
- Acronym / sponsor ID
- R01AT000331
- Conditions
- HIV Infections
- Keywords
- Behavioral intervention, Psychoneuroimmunology, Complementary therapy, Stress and coping, complementary therapies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- May 2005
- First posted
- 10 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aware of HIV-infected diagnosis
Key exclusion criteria (3 listed)
- Current psychoactive drug use
- Severe and unstable psychiatric diagnosis
- Major cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral relaxation (Positively Living) | Behavioural | – |
| Spiritual growth group | Behavioural | – |
| Focused Tai Chi | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive-behavioral relaxation (Positively Living), Spiritual growth group and Focused Tai Chi in people with HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.