HIV Infected IndividualsNCT00180700
The Influence of Psychological Interventions Upon Disease Progression in HIV-infected Patients Receiving no Medication
A study testing Hypnosis in people with HIV Infected Individuals, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study examines the hypothesis that psychological interventions have beneficial effects on quality of life including psychological well-being and disease progression in early HIV patients recieving no medication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV Infected Individuals
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2003to 1 Dec 2003
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- CD4 T-cell counts above 200 cells/mcl
- Signed the informed consent form
Who cannot join
- receiving anti-retroviral drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Two Psychological Intervention Techniques, Self-hypnosis and Johrei Healing Method, on Quality of Life, Psychological Well-being, EEG Measures and Various Immunological Measures Including CD4+ Counts in Early HIV: a Randomly Controlled Pilot Study
This study examines the hypothesis that psychological interventions have beneficial effects on quality of life including psychological well-being and disease progression in early HIV patients recieving no medication.
Read the detailed description
Hypothesis: This investigation is based upon the hypothesis that psychological intervention may counteract the detrimental effects of stress both on psychological well-being and on general health.
Background: HIV infection may be considered to be a life-long biological and psychological stressor leading to detrimental outcomes associated with disease progression. Stress reduction in these patients may have beneficial effects through delaying disease progression via the proposed interactive psycho-neuro-endocrine-immune network.
Inclusion Criteria:
HIV infected individuals CD4 T-cell counts above 200 cells/mcl Receiving no anti-retroviral drugs Individuals who signed the informed consent form
Investigative approach: Self-hypnosis and a Japanese non-touching, laying-on-of hands-like technique, called Johrei, were used to investigate the effects of psychological intervention upon immune parameters (especially in CD4 counts) associated with disease progression along with phenomenological associations between stress perception and stress hormone levels in HIV-infected patients receiving no medication.
- Conditions
- HIV Infected Individuals
- Being tested
- Hypnosis
- Keywords
- HIV, Stress, Psychoneuroimmunology, stress management, hypnosis, Johrei, psychological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis | Experimental | A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 13 participants with diagnosed HIV Receives: Behavioral: Hypnosis |
| Johrei healing method | Experimental | A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 9 participants with diagnosed HIV Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 T-cell counts
Lab test
Measured: 4 weeks
Secondary outcomes (3)
Other immunological parameters (Viral load levels, NK cell counts)
Measured: 4 weeks
Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))
Measured: 4 weeks
Endogenous hormone levels (cortisol, DHEA-S and melatonin)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Jun 2003
- Primary completion1 Dec 2003
- Study completion1 Dec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infected IndividualsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Hammersmith Hospitals NHS Trust, Johrei Association
- Responsible party
- Sponsor
- Investigators
- John H Gruzelier, Ph.D., Principal investigator, Imperial College LondonDon C Henderson, Ph.D., Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180700
- Sponsor's protocol ID
- Johrei_HIV1
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Psychological Intervention Techniques, Self-hypnosis and Johrei Healing Method, on Quality of Life, Psychological Well-being, EEG Measures and Various Immunological Measures Including CD4+ Counts in Early HIV: a Randomly Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00180700
- Acronym / sponsor ID
- Johrei_HIV1
- Conditions
- HIV Infected Individuals
- Keywords
- HIV, Stress, Psychoneuroimmunology, stress management, hypnosis, Johrei, psychological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Hammersmith Hospitals NHS Trust, Johrei Association
- Study start
- 1 Jun 2003 (actual)
- Primary completion
- 1 Dec 2003 (actual)
- Study completion
- 1 Dec 2003 (actual)
- First posted
- 16 Sep 2005 (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.
This study examines the hypothesis that psychological interventions have beneficial effects on quality of life including psychological well-being and disease progression in early HIV patients recieving no medication.
Detailed description
Hypothesis: This investigation is based upon the hypothesis that psychological intervention may counteract the detrimental effects of stress both on psychological well-being and on general health.
Background: HIV infection may be considered to be a life-long biological and psychological stressor leading to detrimental outcomes associated with disease progression. Stress reduction in these patients may have beneficial effects through delaying disease progression via the proposed interactive psycho-neuro-endocrine-immune network.
Inclusion Criteria:
HIV infected individuals CD4 T-cell counts above 200 cells/mcl Receiving no anti-retroviral drugs Individuals who signed the informed consent form
Investigative approach: Self-hypnosis and a Japanese non-touching, laying-on-of hands-like technique, called Johrei, were used to investigate the effects of psychological intervention upon immune parameters (especially in CD4 counts) associated with disease progression along with phenomenological associations between stress perception and stress hormone levels in HIV-infected patients receiving no medication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis | Experimental | Behavioral: HypnosisA course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 13 participants with diagnosed HIV |
| Johrei healing method | Experimental | Behavioral: HypnosisA course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 9 participants with diagnosed HIV |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infected
- CD4 T-cell counts above 200 cells/mcl
- Signed the informed consent form
Key exclusion criteria (1 listed)
- receiving anti-retroviral drugs
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 |
|---|---|---|
| Hypnosis | Behavioural | Johrei healing method, Self-hypnosis |
Primary outcome
CD4 T-cell counts
Time frame: 4 weeks
Lab test
3 secondary outcomes
Other immunological parameters (Viral load levels, NK cell counts)
Time frame: 4 weeks
Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))
Time frame: 4 weeks
Endogenous hormone levels (cortisol, DHEA-S and melatonin)
Time frame: 4 weeks
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
John H Gruzelier, Ph.D. principal investigator
Imperial College London
Don C Henderson, Ph.D. study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with HIV Infected Individuals, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 1 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 8 Jul 2019. 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 Kingdom. 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.
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?
CD4 T-cell counts (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
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 8 Jul 2019.