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Completed

NCT Number: NCT00838994

Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Psychiatry Centre

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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.

Other names: Electroacupuncture

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. Depression state measured by Hamilton Depression Rating Scale (HAMD)

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

  3. 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.

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

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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hong Kong Baptist University

Registry information

Official study title

A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 9, 2009
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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