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

July 3, 2019 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, W6 8RP
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • receiving anti-retroviral drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4 T-cell counts
Time Frame: 4 weeks
Lab test
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Johrei_HIV1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report
    Information comments: Published the results in 2004 Hypnotizability and immunological response to psychological intervention in HIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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