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Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

This study is currently recruiting participants.
Verified January 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01707706
First received: February 22, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Insomnia
Depression
 Other: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire [ Time Frame: Baseline, 1-week posttreatment, and 5-week posttreatment. ] [ Designated as safety issue: No ]
  • Depression state measured by Hamilton Depression Rating Scale (HAMD) [ Time Frame: Baseline, 1-week posttreatment, and 5-week posttreatment. ] [ Designated as safety issue: No ]
  • Depression state measured by Hamilton Anxiety Rating Scale (HAMA) [ Time Frame: Baseline, 1-week posttreatment, and 5-week posttreatment ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, 1-week posttreatment, and 5-week posttreatment ] [ Designated as safety issue: No ]
  • 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 ) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Other: 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 Name: Electroacupuncture
Active Comparator: 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.
 Other: 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 Name: Electroacupuncture
Placebo Comparator: 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.
 Other: 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 Name: Electroacupuncture

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707706

Contacts
Contact: Ka-Fai Chung, MBBS (852)22553656 kfchung@hkucc.hku.hk

Locations
Hong Kong
Western Psychiatry Centre Recruiting
Hong Kong, Hong Kong
Contact: Ka-Fai Chung, MBBS     22553656     kfchung@hkucc.hku.hk    
Sub-Investigator: Wing-Fai Yeung, PhD            
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ka Fai Chung, MBBS The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01707706     History of Changes
Other Study ID Numbers: ACUP-004
Study First Received: February 22, 2012
Last Updated: January 15, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Depression
Electroacupuncture
 Acupuncture
Randomized Clinical Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013