Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder
NCT ID: NCT01707706
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Traditional Acupuncture
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.
Acupuncture
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.
Minimal Acupuncture
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.
Acupuncture
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.
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.
Acupuncture
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.
Interventions
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Acupuncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Ka Fai Chung, MBBS
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Western Psychiatry Centre
Hong Kong, , Hong Kong
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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ACUP-004
Identifier Type: -
Identifier Source: org_study_id