Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

January 12, 2010 updated by: The University of Hong Kong

A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 1:1:1, i.e. equal chance.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Western Psychiatry Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing to give informed consent;
  • Hong Kong resident;
  • Age 18-65 years;
  • Previous DSM-IV Major Depressive Disorder as confirmed with the Structured Clinical Interview for DSM-IV;
  • Hamilton Depression Rating Scale scores of 18 or below for at screening and baseline visit;
  • A chief complaint of insomnia;
  • Able to comply with the trial protocol.

Exclusion Criteria:

  • Any symptoms suggestive of specific sleep disorders, including loud snoring, periodic leg movement, parasomnia;
  • A diagnosis of sleep apnea or periodic limb movement disorder (PLMD) as assessed by overnight polysomnography (PSG);
  • Presence of suicidal risk;
  • Previous history of schizophrenia, other psychotic disorders, and bipolar disorder;
  • Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception;
  • Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Acupuncture
Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the site 1 inch beside the acupoints in order to avoid the acupressure effect. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.
Other: Acupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other Names:
  • Electroacupuncture
Experimental: Traditional Acupuncture
Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (CEFAR Acus II, Lund, Sweden) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.45 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other: Acupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other Names:
  • Electroacupuncture
Active Comparator: Minimal Acupuncture
Patients will be treated superficially at points away from classic acupoints. The points include bilateral "Deltoideus" [in the middle of the line insertion of Binao LI 14 and acromion], "Forearm" [1 inch laterally of the middle point between Shaohai HE3 and Shenmen HE7], "Upper arm" [1 inch laterally of Tianfu LU 3] and "Lower leg" [0.5 inch dorsally of Xuanzhong GB39]. "De qi" is avoided during needling. The treatment procedure, electric-stimulation, frequency, duration and number of treatment sessions will be the same for the Traditional Acupuncture group.
Other: Acupuncture
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other Names:
  • Electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
Time Frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
Time Frame: Baseline, 1-week posttreatment, and 4-week posttreatment.
Baseline, 1-week posttreatment, and 4-week posttreatment.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.
Time Frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Time Frame: Baseline, 1-week posttreatment, and 4-week posttreatment.
Baseline, 1-week posttreatment, and 4-week posttreatment.
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale
Time Frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time Frame: Second and the last time of the treatment.
Second and the last time of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hong Kong Baptist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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