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Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

Sponsor
Herzog Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00788970
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
35
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acupressure adjuvant therapy
 N/A

Detailed Description

Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.

We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.

The goals of this study are twofold:

  1. To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.

  2. To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study
Study Start Date :
Jan 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupressure

Acupressure adjuvant therapy

Behavioral: Acupressure adjuvant therapy
Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
Other Names:
  • Shiatsu

    		•
    Placebo Comparator: Placebo acupressure

    Sham acupressure adjuvant therapy

    Behavioral: Acupressure adjuvant therapy
    Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
    Other Names:
  • Shiatsu

    		•
    No Intervention: No treatment

    Wait list group (no treatment)

    Outcome Measures

    Primary Outcome Measures

    1. Brief Psychiatric Rating Scale (BPRS) [16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. DSM-IV diagnosis of schizophrenia or schizoaffective disorder

    2. Ages 18 and over

    3. Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall & Gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage.

    4. Ability to cooperate with 40-minute sessions

    Exclusion Criteria:

    1. Unstable general medical conditions

    2. Active bone fracture or other orthopedic problem

    3. Skin condition that renders treatment unsafe or painful

    4. Active infection in skin or soft tissues, such as cellulitis

    5. Solid tissue malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herzog Hospital, Department of Psychiatry Jerusalem Israel 91351

    Sponsors and Collaborators

    • Herzog Hospital

    Investigators

    • Principal Investigator: Pesach Lichtenberg, M.D., Herzog Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00788970
    Other Study ID Numbers:
    • lichtenberg3
    First Posted:
    Nov 11, 2008
    Last Update Posted:
    Jan 13, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    Acupressure
    Shiatsu
    Schizophrenia
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Jan 13, 2009