HIV InfectionsPhase 2NCT00057538
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
A Phase 2 study testing Mantram Repetition in people with HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Mantram Repetition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2003
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected for at least 6 months
- Ability to read and write English
Who cannot join
- Drug use within the past 6 months
- Cognitive impairment or dementia
- Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
- Loss of family/loved one in past 3 months
- Started a relaxation therapy in past 3 months
- History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)
- Acute infection in past month
- Change of HAART or drug regimen in past month
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.
Read the detailed description
It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.
- Conditions
- HIV Infections
- Being tested
- Mantram Repetition
- Keywords
- HIV, Randomized Trial, Stress, Spirituality, Quality of Life, 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.
Mantram RepetitionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger
Secondary outcomes (6)
Spiritual Well-Being (FACIT-SpEx)
Quality of Life Enjoyment and Satisfaction
Ways of Coping
Urinary cortisol levels
Urinary catecholamines
Salivary cortisol levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2003 (estimated)
- Study startMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, San Diego
- Investigators
- Jill E. Bormann, PhD, RN, Principal investigator, California San Diego Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057538
- Sponsor's protocol ID
- R21AT001159-01A1
- Status last verified
- Aug 2006
- First submitted
- 4 Apr 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.
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
- Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
- ClinicalTrials.gov ID
- NCT00057538
- Acronym / sponsor ID
- R21AT001159-01A1
- Conditions
- HIV Infections
- Keywords
- HIV, Randomized Trial, Stress, Spirituality, Quality of Life, Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- University of California, San Diego
- Study start
- May 2003
- Study completion
- May 2003
- First posted
- 7 Apr 2003 (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 purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.
Detailed description
It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV infected for at least 6 months
- Ability to read and write English
Key exclusion criteria (8 listed)
- Drug use within the past 6 months
- Cognitive impairment or dementia
- Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
- Loss of family/loved one in past 3 months
- Started a relaxation therapy in past 3 months
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 |
|---|---|---|
| Mantram Repetition | Behavioural | – |
Primary outcome
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger
6 secondary outcomes
Spiritual Well-Being (FACIT-SpEx)
Quality of Life Enjoyment and Satisfaction
Ways of Coping
Urinary cortisol levels
Urinary catecholamines
Salivary cortisol levels
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.
- BackgroundBormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.
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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.
Jill E. Bormann, PhD, RN principal investigator
California San Diego Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mantram Repetition 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 2 inclusion and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Intrusive Thoughts. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057538, which also lists 1 linked publication.
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.