A Randomized Controlled Trial of Acupuncture for Residual Insomnia Associated With Major Depressive Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- The University of Hong Kong
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Self-rated sleep quality score measured by Insomnia Severity Index questionnaire
- Status
- Completed
- Last Updated
- 16 years ago
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 1:1:1, i.e. equal chance.
Investigators
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.
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(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.)