Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

The University of Hong Kong78 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insomnia Depression

Interventions

AcupunctureOTHER

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Western Psychiatry Centre

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Self-rated sleep quality score measured by Insomnia Severity Index questionnaire

Time frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy

Time frame: Baseline, 1-week posttreatment, and 4-week posttreatment.

Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.

Time frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Secondary Outcomes

Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

Time frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Depression state measured by Hamilton Depression Rating Scale (HAMD)

Time frame: Baseline, 1-week posttreatment, and 4-week posttreatment.

Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale

Time frame: Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Subjects' credibility to the treatment measured by Credibility of treatment rating scale

Time frame: Second and the last time of the treatment.

Data from ClinicalTrials.gov

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