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The Influence of Psychological Interventions Upon Disease Progression in HIV-infected Patients Receiving no Medication

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ClinicalTrials.gov Identifier: NCT00180700
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 12, 2016
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
HIV Infected Individuals Behavioral: Self-hypnosis Behavioral: Johrei - a Japanese stress management system

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : June 2003
Estimated Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. CD4 T-cell counts

Secondary Outcome Measures :
  1. Other immunological parameters (Viral load levels, NK cell counts)
  2. Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))
  3. Endogenous hormone levels (cortisol, DHEA-S and melatonin)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • CD4 T-cell counts above 200 cells/mcl
  • Signed the informed consent form

Exclusion Criteria:

  • receiving anti-retroviral drugs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180700


Locations
United Kingdom
Imperial College London
London, England, United Kingdom, W6 8RP
Sponsors and Collaborators
Imperial College London
Hammersmith Hospitals NHS Trust
Johrei Association
Investigators
Principal Investigator: John H Gruzelier, Ph.D. Imperial College London
Study Director: Don C Henderson, Ph.D. Imperial College London
More Information

ClinicalTrials.gov Identifier: NCT00180700     History of Changes
Other Study ID Numbers: Johrei_HIV1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: September 2005

Keywords provided by Imperial College London:
HIV
Stress
Psychoneuroimmunology
stress management
hypnosis
Johrei
psychological intervention