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

NCT00780884 | Completed DMC

• 1 other identifier: 0015-08
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective

Keywords

acupuncture; schizophrenia; insomnia

Outcome Measures

Primary Outcomes (1)

• sleep efficiency

  8 weeks

Secondary Outcomes (1)

• anxiety and depression levels

  8 weeks

Study Arms (1)

acupuncture needles

EXPERIMENTAL

Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD.

Device: acupuncture

Interventions

acupuncture DEVICE

16 sessions of acupuncture treatment, twice a week.

acupuncture needles

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unstable physical illness
• drug or alchohol abuse or dependence

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Schizophrenia; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ilana Kremer, MD

  Haemek Mediacl Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2008
• First Posted: October 28, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

IL (1)