Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

The University of Hong Kong (HKU)

Status: Completed

Conditions: Insomnia; Depression

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01707706

ACUP-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Traditional Acupuncture

Experimental group

Description:

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.

Treatment:

Other: Acupuncture

Minimal Acupuncture

Active Comparator group

Description:

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.

Treatment:

Other: Acupuncture

Placebo Acupuncture

Placebo Comparator group

Description:

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.

Treatment:

Other: Acupuncture