Depression, Insomnia
Conditions
Keywords
Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
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.
Interventions
OTHERAcupuncture
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.
Sponsors
Hong Kong Baptist University
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
| Subjects' credibility to the treatment measured by Credibility of treatment rating scale | Second and the last time of the treatment. |
| 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. |
Countries
Hong Kong
Outcome results
None listed