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

The University of Hong Kong1 site in 1 country150 target enrollmentJanuary 2011

ConditionsInsomnia Depression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia
Sponsor: The University of Hong Kong
Enrollment: 150
Locations: 1
Primary Endpoint: Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Hong Kong

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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 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)
Depression state measured by Hamilton Depression Rating Scale (HAMD)(Baseline, 1-week posttreatment, and 5-week posttreatment.)
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 Anxiety Rating Scale (HAMA)(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)
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)
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.)
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 subjective measures using sleep log.(Baseline, 1-week posttreatment, and 5-week posttreatment.)