Shiatsu Adjuvant Therapy And Placebo For Schizophrenia

NCT ID: NCT00788970

Last Updated: 2009-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Acupressure

Acupressure adjuvant therapy

Group Type EXPERIMENTAL

Acupressure adjuvant therapy

Intervention Type BEHAVIORAL

Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.

Placebo acupressure

Sham acupressure adjuvant therapy

Group Type PLACEBO_COMPARATOR

Acupressure adjuvant therapy

Intervention Type BEHAVIORAL

Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.

No treatment

Wait list group (no treatment)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupressure adjuvant therapy

Acupressure provided in 40-minute sessions, twice a week for 4 weeks. For placebo acupressure, different meridian points will be used.

Intervention Type BEHAVIORAL

Other Intervention Names

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Shiatsu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herzog Hospital

OTHER

Sponsor Role lead

Responsible Party

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Herzog Hospital

Principal Investigators

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Pesach Lichtenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Herzog Hospital

Locations

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Herzog Hospital, Department of Psychiatry

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Pesach Lichtenberg

Role: CONTACT

972-2-5316929

Other Identifiers

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lichtenberg3

Identifier Type: -

Identifier Source: org_study_id

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