Clinical trial NCT00838994: Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
Official title: A Randomized Controlled Trial of Acupuncture for Residual Insomnia 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
Collaborators: name: Hong Kong Baptist University
First posted: 2009-02-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 1:1:1, i.e. equal chance.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.

Primary outcomes:
measure: Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
timeFrame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
measure: Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy
timeFrame: Baseline, 1-week posttreatment, and 4-week posttreatment.
measure: Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.
timeFrame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Secondary outcomes:
measure: Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
measure: Depression state measured by Hamilton Depression Rating Scale (HAMD)
timeFrame: Baseline, 1-week posttreatment, and 4-week posttreatment.
measure: Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale
timeFrame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
measure: Subjects' credibility to the treatment measured by Credibility of treatment rating scale
timeFrame: Second and the last time of the treatment.
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, 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.