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Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Primary Purpose

Insomnia, Depression

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Western Psychiatry Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Traditional Acupuncture

Minimal Acupuncture

Placebo Acupuncture

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.

Secondary Outcome Measures

Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale
Subjects' credibility to the treatment measured by Credibility of treatment rating scale

Full Information

First Posted
February 6, 2009
Last Updated
January 12, 2010
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University
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1. Study Identification

Unique Protocol Identification Number
NCT00838994
Brief Title
Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
Official Title
A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Baptist University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression
Keywords
Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Minimal Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Acupuncture
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Time Frame
Baseline, 1-week posttreatment, and 4-week posttreatment.
Title
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.
Title
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time Frame
Second and the last time of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka-Fai Chung, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatry Centre
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
27503746
Citation
Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.
Results Reference
derived
PubMed Identifier
21629370
Citation
Yeung WF, Chung KF, Tso KC, Zhang SP, Zhang ZJ, Ho LM. Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep. 2011 Jun 1;34(6):807-15. doi: 10.5665/SLEEP.1056.
Results Reference
derived

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Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

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