Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

NCT01707706 | Completed

• 1 other identifier: ACUP-004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia; Depression

Keywords

Insomnia; Depression; Electroacupuncture; Acupuncture; Randomized Clinical Trial; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire

  Baseline, 1-week and 5-week posttreatment.

Secondary Outcomes (14)

• Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

  Baseline, 1-week posttreatment, and 5-week posttreatment.

• Depression state measured by Hamilton Depression Rating Scale (HAMD)

  Baseline, 1-week posttreatment, and 5-week posttreatment.

• Depression state measured by Hamilton Anxiety Rating Scale (HAMA)

  Baseline, 1-week posttreatment, and 5-week posttreatment

• Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)

  Baseline, 1-week posttreatment, and 5-week posttreatment.

• Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)

  Baseline, 1-week posttreatment and 5-week posttreatment

Study Arms (3)

Traditional Acupuncture

EXPERIMENTAL

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.

Other: Acupuncture

Minimal Acupuncture

ACTIVE COMPARATOR

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.

Other: Acupuncture

Placebo Acupuncture

PLACEBO COMPARATOR

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

Interventions

Acupuncture OTHER

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.

Also known as: Electroacupuncture

Minimal Acupuncture; Placebo Acupuncture; Traditional Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Western Psychiatry Centre

Hong Kong, Hong Kong

Location

Related Publications (4)

• 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.

  PMID: 27503746 DERIVED

• 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.

  PMID: 26498238 DERIVED

• 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.

  PMID: 26132682 DERIVED

• 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.

  PMID: 25271149 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Interventions

Acupuncture Therapy; Electroacupuncture

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ka Fai Chung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: October 16, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

HK (1)