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

Not Applicable

Completed

• Conditions: HIV Infected Individuals
• Interventions: Behavioral: Hypnosis

• Registration Number: NCT00180700
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study Start: 2003-06-01
• Primary Completion: 2003-12-01
• Study Completion: 2003-12-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• receiving anti-retroviral drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Johrei healing method	Hypnosis	A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 9 participants with diagnosed HIV
Self-hypnosis	Hypnosis	A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 13 participants with diagnosed HIV

Primary Outcome Measures

Name	Time	Method
CD4 T-cell counts	4 weeks	Lab test

Secondary Outcome Measures

Name	Time	Method
Endogenous hormone levels (cortisol, DHEA-S and melatonin)	4 weeks
Other immunological parameters (Viral load levels, NK cell counts)	4 weeks
Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))	4 weeks

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, England, United Kingdom