<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01707706</url>
  </required_header>
  <id_info>
    <org_study_id>ACUP-004</org_study_id>
    <nct_id>NCT01707706</nct_id>
  </id_info>
  <brief_title>Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder</brief_title>
  <official_title>A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment&#xD;
      on residual insomnia in major depressive patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized single-blinded controlled trial. Patients will be randomly assigned to&#xD;
      one of the three groups. One is the traditional acupuncture treatment group, one is the&#xD;
      non-traditional acupuncture treatment group and the other is an acupuncture-like placebo&#xD;
      treatment. Patients will be put into groups and then compared. The chance of getting into&#xD;
      each group is 2:2:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire</measure>
    <time_frame>Baseline, 1-week and 5-week posttreatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression state measured by Hamilton Depression Rating Scale (HAMD)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression state measured by Hamilton Anxiety Rating Scale (HAMA)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)</measure>
    <time_frame>Baseline, 1-week posttreatment and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects' credibility to the treatment measured by Credibility of treatment rating scale</measure>
    <time_frame>Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline )</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events measured by Serious Adverse Event (SAE)</measure>
    <time_frame>1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture</measure>
    <time_frame>1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>Baseline, 1-week posttreatment, and 5-week posttreatment.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Insomnia</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Traditional Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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. &quot;De qi&quot;(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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minimal Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated superficially at points away from classic acupoints. The points include bilateral &quot;Forearm&quot; [1 inch lateral to the middle point between HE3 and HE7] , &quot;Upper arm&quot; [1 inch lateral to LU 3 ], and &quot;Lower leg&quot; [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral &quot;Head&quot; [middle point between GB8 and ST8], &quot;Forehead&quot; [middle point between ST8 and GB14], &quot;Neck&quot; [middle point between TB16 and SI17], and &quot;Ear&quot; [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. &quot;De qi&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Acupuncture</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <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.</description>
    <arm_group_label>Minimal Acupuncture</arm_group_label>
    <arm_group_label>Placebo Acupuncture</arm_group_label>
    <arm_group_label>Traditional Acupuncture</arm_group_label>
    <other_name>Electroacupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or above&#xD;
&#xD;
          -  A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive&#xD;
             Disorder&#xD;
&#xD;
          -  Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of&#xD;
             insomnia disorder&#xD;
&#xD;
          -  Insomnia more than 3 nights per week for at least 3 months&#xD;
&#xD;
          -  Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline&#xD;
             visit&#xD;
&#xD;
          -  Use of antidepressants at the same dosage for at least 12 weeks prior to screening&#xD;
             visit&#xD;
&#xD;
          -  Hypnotic dosage has not been increased in the last 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a Hamilton Depression Rating Scale scores above 18&#xD;
&#xD;
          -  Have sleep apnea or periodic limbs movement disorder detected by overnight&#xD;
             polysomnography&#xD;
&#xD;
          -  Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk&#xD;
             item&#xD;
&#xD;
          -  Have previous history of schizophrenia, other psychotic disorders, and bipolar&#xD;
             disorder&#xD;
&#xD;
          -  Have current alcohol or drug abuse and dependence&#xD;
&#xD;
          -  Pregnant, breast-feeding, or woman of childbearing potential not using adequate&#xD;
             contraception&#xD;
&#xD;
          -  Have infection or abscess close to the site of selected acupoints and in the&#xD;
             investigator's opinion inclusion is unsafe&#xD;
&#xD;
          -  Taking Chinese herbal medicine or over-the-counter drugs which are intending for&#xD;
             insomnia within the last 2 weeks prior to baseline or during the study&#xD;
&#xD;
          -  Any acupuncture treatment during the previous 12 months prior to baseline and&#xD;
&#xD;
          -  Unstable medical conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka Fai Chung, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Psychiatry Centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>February 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>December 12, 2013</last_update_submitted>
  <last_update_submitted_qc>December 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Depression</keyword>
  <keyword>Electroacupuncture</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Randomized Clinical Trial</keyword>
  <keyword>Traditional Chinese Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 30, 2021</submitted>
    <returned>October 28, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707706
org study id: ACUP-004
nct id: NCT01707706
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment
      on residual insomnia in major depressive patients.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 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.
measure: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Depression state measured by Hamilton Depression Rating Scale (HAMD)
time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
time frame: Baseline, 1-week posttreatment, and 5-week posttreatment
measure: 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.
measure: 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
measure: 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
measure: 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.
measure: 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.
measure: Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
time frame: Baseline, 1-week posttreatment, and 5-week posttreatment
measure: 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 )
measure: 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
measure: 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
measure: 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.
measure: 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.
arm group label: Traditional Acupuncture
arm group type: Experimental
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 group label: Minimal Acupuncture
arm group type: Active Comparator
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 group label: Placebo Acupuncture
arm group type: Placebo Comparator
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: Acupuncture
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.
arm group label: Minimal Acupuncture
arm group label: Placebo Acupuncture
arm group label: Traditional Acupuncture
other name: Electroacupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ka Fai Chung, MBBS
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
submitted: September 30, 2021
returned: October 28, 2021