Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Herzog Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00788970
First received: November 10, 2008
Last updated: January 12, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention
Schizophrenia
Behavioral: Acupressure adjuvant therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study

Resource links provided by NLM:


Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Shiatsu
No Intervention: No treatment
Wait list group (no treatment)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788970

Contacts
Contact: Pesach Lichtenberg 972-2-5316929 licht@cc.huji.ac.il

Locations
Israel
Herzog Hospital, Department of Psychiatry
Jerusalem, Israel, 91351
Sponsors and Collaborators
Herzog Hospital
Investigators
Principal Investigator: Pesach Lichtenberg, M.D. Herzog Hospital
  More Information

No publications provided

Responsible Party: Dr. Pesach Lichtenberg, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00788970     History of Changes
Other Study ID Numbers: lichtenberg3
Study First Received: November 10, 2008
Last Updated: January 12, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Herzog Hospital:
Acupressure
Shiatsu
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014