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

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT00180700

Collaborator

Hammersmith Hospitals NHS Trust (Other), Johrei Association (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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	Phase
HIV Infected Individuals	Behavioral: Hypnosis	N/A

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

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single blinded

Primary Purpose:

Other

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

Actual Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-hypnosis A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 13 participants with diagnosed HIV	Behavioral: Hypnosis
Experimental: Johrei healing method A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 9 participants with diagnosed HIV	Behavioral: Hypnosis

Arm

Intervention/Treatment

Experimental: Self-hypnosis

A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 13 participants with diagnosed HIV

Behavioral: Hypnosis

Experimental: Johrei healing method

A course of four weekly 2-hour training sessions coupled with daily self-hypnosis practice was given to 9 participants with diagnosed HIV

Behavioral: Hypnosis

Outcome Measures

Primary Outcome Measures

CD4 T-cell counts [4 weeks]
Lab test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Imperial College London

ClinicalTrials.gov Identifier:

NCT00180700

Other Study ID Numbers:

Johrei_HIV1

First Posted:

Sep 16, 2005

Last Update Posted:

Jul 8, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Imperial College London

HIV

Stress

Psychoneuroimmunology

stress management

hypnosis

Johrei

psychological intervention

Study Results

No Results Posted as of Jul 8, 2019