NCT00788970

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

2.9 years

First QC Date

November 10, 2008

Last Update Submit

January 12, 2009

Conditions

Keywords

AcupressureShiatsuSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Brief Psychiatric Rating Scale (BPRS)

    16 weeks

Study Arms (3)

Acupressure

EXPERIMENTAL

Acupressure adjuvant therapy

Behavioral: Acupressure adjuvant therapy

Placebo acupressure

PLACEBO COMPARATOR

Sham acupressure adjuvant therapy

Behavioral: Acupressure adjuvant therapy

No treatment

NO INTERVENTION

Wait list group (no treatment)

Interventions

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

Also known as: Shiatsu
AcupressurePlacebo acupressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital, Department of Psychiatry

Jerusalem, 91351, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Pesach Lichtenberg, M.D.

    Herzog Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pesach Lichtenberg

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations