Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

NCT00838994 | Completed

• 1 other identifier: ACUP-002
• Study Type: interventional
• Target: 78
• 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 (3)

• Self-rated sleep quality score measured by Insomnia Severity Index questionnaire

  Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

• Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy

  Baseline, 1-week posttreatment, and 4-week posttreatment.

• Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.

  Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Secondary Outcomes (4)

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

  Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

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

  Baseline, 1-week posttreatment, and 4-week posttreatment.

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

  Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

• Subjects' credibility to the treatment measured by Credibility of treatment rating scale

  Second and the last time of the treatment.

Study Arms (3)

Traditional Acupuncture

EXPERIMENTAL

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.

Other: Acupuncture

Minimal Acupuncture

ACTIVE COMPARATOR

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.

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Baptist University: collaborator

Study Sites (1)

Western Psychiatry Centre

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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, 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.

  PMID: 21629370 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

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

HK (1)