Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Acupuncture<br>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<br>* 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.<br>* Other names: Electroacupuncture;|
| Active Comparator: Minimal Acupuncture<br>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<br>* 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.<br>* Other names: Electroacupuncture;|
| Placebo Comparator: Placebo Acupuncture<br>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<br>* 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.<br>* Other names: Electroacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS) |  | Baseline, 1-week posttreatment, and 5-week posttreatment | 
| Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS) |  | Baseline, 1-week posttreatment, and 5-week posttreatment. | 
| 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) |  | Baseline, 1-week posttreatment, and 5-week posttreatment. | 
| Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) |  | Baseline, 1-week posttreatment, and 5-week posttreatment | 
| Subjects' credibility to the treatment measured by Credibility of treatment rating scale |  | Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline ) | 
| Serious adverse events measured by Serious Adverse Event (SAE) |  | 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment | 
| Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture |  | 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment | 
| 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 |  | Baseline, 1-week posttreatment, and 5-week posttreatment. | 
| 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. |  | Baseline, 1-week posttreatment, and 5-week posttreatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine