The Influence of Psychological Interventions Upon Disease Progression in HIV-Infected Patients Receiving No Medication

This study has been completed.
Sponsor:
Collaborators:
Hammersmith Hospitals NHS Trust
Johrei Association
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180700
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
HIV Infected Individuals
Behavioral: Self-hypnosis
Behavioral: Johrei - a Japanese stress management system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • CD4 T-cell counts

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

Estimated Enrollment: 100
Study Start Date: June 2003
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00180700     History of Changes
Other Study ID Numbers: Johrei_HIV1
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Disease Progression
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014