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Acupuncture for Persistent 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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or above
  • A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder
  • Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder
  • Insomnia more than 3 nights per week for at least 3 months
  • Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit
  • Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
  • Hypnotic dosage has not been increased in the last 4 weeks

Exclusion Criteria:

  • Have a Hamilton Depression Rating Scale scores above 18
  • Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
  • Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
  • Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
  • Have current alcohol or drug abuse and dependence
  • Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
  • Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
  • Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
  • Any acupuncture treatment during the previous 12 months prior to baseline and
  • Unstable medical conditions.

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, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, 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 (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 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 "Forearm" [1 inch lateral to the middle point between HE3 and HE7] , "Upper arm" [1 inch lateral to LU 3 ], and "Lower leg" [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral "Head" [middle point between GB8 and ST8], "Forehead" [middle point between ST8 and GB14], "Neck" [middle point between TB16 and SI17], and "Ear" [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. "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 changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire

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)
Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)
Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Serious adverse events measured by Serious Adverse Event (SAE)
Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by objective measure - wrist actigraphy
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.

Full Information

First Posted
February 22, 2012
Last Updated
December 12, 2013
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01707706
Brief Title
Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder
Official Title
A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

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 2:2:1.

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
150 (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, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, 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 (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 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 "Forearm" [1 inch lateral to the middle point between HE3 and HE7] , "Upper arm" [1 inch lateral to LU 3 ], and "Lower leg" [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral "Head" [middle point between GB8 and ST8], "Forehead" [middle point between ST8 and GB14], "Neck" [middle point between TB16 and SI17], and "Ear" [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. "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 , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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 changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
Time Frame
Baseline, 1-week and 5-week posttreatment.
Secondary Outcome Measure Information:
Title
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment
Title
Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Time Frame
Baseline, 1-week posttreatment and 5-week posttreatment
Title
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment
Title
Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment
Title
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time Frame
Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline )
Title
Serious adverse events measured by Serious Adverse Event (SAE)
Time Frame
1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
Title
Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
Time Frame
1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
Title
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by objective measure - wrist actigraphy
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.
Title
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
Time Frame
Baseline, 1-week posttreatment, and 5-week posttreatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or above A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder Insomnia more than 3 nights per week for at least 3 months Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit Hypnotic dosage has not been increased in the last 4 weeks Exclusion Criteria: Have a Hamilton Depression Rating Scale scores above 18 Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder Have current alcohol or drug abuse and dependence Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study Any acupuncture treatment during the previous 12 months prior to baseline and Unstable medical conditions.
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
26498238
Citation
Yeung WF, Chung KF, Yu BY, Lao L. Response to placebo acupuncture in insomnia: a secondary analysis of three randomized controlled trials. Sleep Med. 2015 Nov;16(11):1372-1376. doi: 10.1016/j.sleep.2015.07.027. Epub 2015 Aug 31.
Results Reference
derived
PubMed Identifier
26132682
Citation
Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
Results Reference
derived
PubMed Identifier
25271149
Citation
Chung KF, Yeung WF, Kwok CW, Yu YM. Risk factors associated with adverse events of acupuncture: a prospective study. Acupunct Med. 2014 Dec;32(6):455-62. doi: 10.1136/acupmed-2014-010635. Epub 2014 Sep 30.
Results Reference
derived

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Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

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