NCT00180700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

September 13, 2005

Last Update Submit

July 3, 2019

Conditions

HIV Infected Individuals

Keywords

HIVStressPsychoneuroimmunologystress managementhypnosisJohreipsychological intervention

Outcome Measures

Primary Outcomes (1)

  • CD4 T-cell counts

    Lab test

    4 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Self-hypnosis

EXPERIMENTAL

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

Johrei healing method

EXPERIMENTAL

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

Interventions

HypnosisBEHAVIORAL
Johrei healing methodSelf-hypnosis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • receiving anti-retroviral drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, England, W6 8RP, United Kingdom

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • John H Gruzelier, Ph.D.

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Don C Henderson, Ph.D.

    Imperial College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)