Clinical trial NCT00180700: The Influence of Psychological Interventions Upon Disease Progression in HIV-infected Patients Receiving no Medication
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infected Individuals
Keywords: HIV
Stress
Psychoneuroimmunology
stress management
hypnosis
Johrei
psychological intervention
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Hammersmith Hospitals NHS Trust
name: Johrei Association
First posted: 2005-09-16
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* receiving anti-retroviral drugs

Primary outcomes:
measure: CD4 T-cell counts
timeFrame: 4 weeks
Secondary outcomes:
measure: Other immunological parameters (Viral load levels, NK cell counts)
timeFrame: 4 weeks
measure: Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))
timeFrame: 4 weeks
measure: Endogenous hormone levels (cortisol, DHEA-S and melatonin)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
state: England
Study officials:
affiliation: Imperial College London
name: John H Gruzelier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Don C Henderson, Ph.D.
role: STUDY_DIRECTOR
References: