Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00780884
First received: October 26, 2008
Last updated: July 7, 2011
Last verified: October 2008
  Purpose

Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.


Condition Intervention
Schizophrenia
Schizoaffective
Device: acupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • sleep efficiency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anxiety and depression levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture needles
Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD.
Device: acupuncture
16 sessions of acupuncture treatment, twice a week.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
  2. capability to sign inform consent.

Exclusion Criteria:

  1. unstable physical illness
  2. drug or alchohol abuse or dependence
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00780884

Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Ilana Kremer, MD Haemek Mediacl Center
  More Information

No publications provided

Responsible Party: Ilana Kremer, Haemek Medical Center
ClinicalTrials.gov Identifier: NCT00780884     History of Changes
Other Study ID Numbers: 0015-08
Study First Received: October 26, 2008
Last Updated: July 7, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
acupuncture
schizophrenia
insomnia

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

ClinicalTrials.gov processed this record on August 20, 2014