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Completed

NCT Number: NCT00180700

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

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.

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Key information

Conditions

HIV Infected Individuals

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, England, W6 8RP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • receiving anti-retroviral drugs

Treatment and study plan

hypnosis

Behavioral

Primary outcomes

  1. CD4 T-cell counts

    Time frame: 4 weeks

    Lab test

Secondary outcomes

  1. Other immunological parameters (Viral load levels, NK cell counts)

    Time frame: 4 weeks

  2. Psychological questionnaires (Perceived Stress Scale (PSS), STAI, Beck depression Inventory (BDI))

    Time frame: 4 weeks

  3. Endogenous hormone levels (cortisol, DHEA-S and melatonin)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Hammersmith Hospitals NHS Trust
  • Johrei Association

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Sep 16, 2005
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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