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Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Acupressure adjuvant therapy
Sponsored by
Herzog Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Acupressure, Shiatsu, Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzog Hospital, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Acupressure

Placebo acupressure

No treatment

Arm Description

Acupressure adjuvant therapy

Sham acupressure adjuvant therapy

Wait list group (no treatment)

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale (BPRS)

Secondary Outcome Measures

Full Information

First Posted
November 10, 2008
Last Updated
January 12, 2009
Sponsor
Herzog Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00788970
Brief Title
Shiatsu Adjuvant Therapy And Placebo For Schizophrenia
Official Title
Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Herzog Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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: To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia. To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Acupressure, Shiatsu, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
Acupressure adjuvant therapy
Arm Title
Placebo acupressure
Arm Type
Placebo Comparator
Arm Description
Sham acupressure adjuvant therapy
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Wait list group (no treatment)
Intervention Type
Behavioral
Intervention Name(s)
Acupressure adjuvant therapy
Other Intervention Name(s)
Shiatsu
Intervention Description
Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder Ages 18 and over 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. Ability to cooperate with 40-minute sessions Exclusion Criteria: Unstable general medical conditions Active bone fracture or other orthopedic problem Skin condition that renders treatment unsafe or painful Active infection in skin or soft tissues, such as cellulitis Solid tissue malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pesach Lichtenberg
Phone
972-2-5316929
Email
licht@cc.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pesach Lichtenberg, M.D.
Organizational Affiliation
Herzog Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzog Hospital, Department of Psychiatry
City
Jerusalem
ZIP/Postal Code
91351
Country
Israel

12. IPD Sharing Statement

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Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

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