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Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Hong Kong Baptist University
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00838994
First received: February 6, 2009
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention
Insomnia
Depression
 Other: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Depression state measured by Hamilton Depression Rating Scale (HAMD) [ Time Frame: Baseline, 1-week posttreatment, and 4-week posttreatment. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Subjects' credibility to the treatment measured by Credibility of treatment rating scale [ Time Frame: Second and the last time of the treatment. ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Electroacupuncture
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 Name: Electroacupuncture

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838994

Locations
Hong Kong
Western Psychiatry Centre
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Baptist University
Investigators
Principal Investigator: Ka-Fai Chung, MBBS The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Chung Ka-Fai/ Associate Professor, Department of Psychiatry, the University of Hong Kong
ClinicalTrials.gov Identifier: NCT00838994     History of Changes
Other Study ID Numbers: ACUP-002
Study First Received: February 6, 2009
Last Updated: January 12, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Depression
Electroacupuncture
 Acupuncture
Randomized Clinical Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013