Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Not Applicable

Completed

• Conditions: Insomnia; Depression

• Registration Number: NCT00838994
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire	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	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.	Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.

Secondary Outcome Measures

Name	Time	Method
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire	Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Depression state measured by Hamilton Depression Rating Scale (HAMD)	Baseline, 1-week posttreatment, and 4-week posttreatment.
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale	Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.
Subjects' credibility to the treatment measured by Credibility of treatment rating scale	Second and the last time of the treatment.

Trial Locations

Locations (1)

Western Psychiatry Centre; 🇭🇰 Hong Kong, Hong Kong