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 2:2:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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.
Western Psychiatry Centre
Hong Kong, Hong Kong
Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire
Time frame: Baseline, 1-week and 5-week posttreatment.
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment
Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Time frame: Baseline, 1-week posttreatment and 5-week posttreatment
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment
Self-rated assessment regarding the degree of catastrophic thoughts about pain measured by Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Time frame: Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline )
Serious adverse events measured by Serious Adverse Event (SAE)
Time frame: 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture
Time frame: 1-week, 2-week, and 3-week post-baseline, 1-week and 5-week posttreatment
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by objective measure - wrist actigraphy
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
Time frame: Baseline, 1-week posttreatment, and 5-week posttreatment.