Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

Not Applicable

Completed

• Conditions: Insomnia; Depression

• Registration Number: NCT01707706
• 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 2:2:1.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-10-14
• Study First Posted: 2012-10-16
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Aged 18 years or above
• A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder
• Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder
• Insomnia more than 3 nights per week for at least 3 months
• Insomnia Severity Scale (ISI) total score higher than 15 at screening and baseline visit
• Use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
• Hypnotic dosage has not been increased in the last 4 weeks

Exclusion Criteria

• Have a Hamilton Depression Rating Scale scores above 18
• Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
• Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
• Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
• Have current alcohol or drug abuse and dependence
• Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
• Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
• Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
• Any acupuncture treatment during the previous 12 months prior to baseline and
• Unstable medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire	Baseline, 1-week and 5-week posttreatment.

Secondary Outcome Measures

Name	Time	Method
Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)	Baseline, 1-week posttreatment, and 5-week posttreatment.
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)	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)	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)	Baseline, 1-week posttreatment, and 5-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)	Baseline, 1-week posttreatment, and 5-week posttreatment
Depression state measured by Hamilton Depression Rating Scale (HAMD)	Baseline, 1-week posttreatment, and 5-week posttreatment.
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire	Baseline, 1-week posttreatment, and 5-week posttreatment.
Depression state measured by Hamilton Anxiety Rating Scale (HAMA)	Baseline, 1-week posttreatment, and 5-week posttreatment
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)	Baseline, 1-week posttreatment, and 5-week posttreatment
Subjects' credibility to the treatment measured by Credibility of treatment rating scale	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)	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	Baseline, 1-week posttreatment, and 5-week posttreatment.
Potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture	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 subjective measures using sleep log.	Baseline, 1-week posttreatment, and 5-week posttreatment.

Trial Locations

Locations (1)

Western Psychiatry Centre; 🇭🇰 Hong Kong, Hong Kong