Clinical trial NCT01707706: Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder
Official title: A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Insomnia
Depression
Electroacupuncture
Acupuncture
Randomized Clinical Trial
Traditional Chinese Medicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
timeFrame: Baseline, 1-week and 5-week posttreatment.
Secondary outcomes:
measure: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Depression state measured by Hamilton Depression Rating Scale (HAMD)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment
measure: Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1-week posttreatment and 5-week posttreatment
measure: Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment
measure: Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: 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)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment
measure: Subjects' credibility to the treatment measured by Credibility of treatment rating scale
timeFrame: Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline )
measure: Serious adverse events measured by Serious Adverse Event (SAE)
timeFrame: 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
measure: Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
timeFrame: 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
measure: 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
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
measure: 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.
timeFrame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Western Psychiatry Centre
Study officials:
affiliation: The University of Hong Kong
name: Ka Fai Chung, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.