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

HIV Infected Individuals Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180700
• Other study ID #: Johrei_HIV1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2003
• Est. completion date: December 1, 2003

Study information

• Verified date: July 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 1, 2003
• Est. primary completion date: December 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• HIV infected

• CD4 T-cell counts above 200 cells/mcl

• Signed the informed consent form

Exclusion Criteria:

• receiving anti-retroviral drugs

Related Conditions & MeSH terms

• HIV Infected Individuals

Intervention

Behavioral:
• Hypnosis

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London	England

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Hammersmith Hospitals NHS Trust, Johrei Association

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 T-cell counts	Lab test	4 weeks
Secondary	Other immunological parameters (Viral load levels, NK cell counts)		4 weeks
Secondary	Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))		4 weeks
Secondary	Endogenous hormone levels (cortisol, DHEA-S and melatonin)		4 weeks