InsomniaNCT01707706

Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder

A study testing Acupuncture in people with Insomnia and Depression, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia, Depression
What is being tested?: Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteHong Kong
Study dates: Jan 2011to Dec 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Western Psychiatry Centre
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms 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.

Read the 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.

Conditions: Insomnia, Depression
Being tested: Acupuncture
Keywords: Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
Medical subject headings: Sleep Initiation and Maintenance Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
Also called Electroacupuncture
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.

Study groups in NCT01707706
Study group	Role	What they receive
Traditional Acupuncture	Experimental	Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks. Receives: Other: Acupuncture
Minimal Acupuncture	Active comparator	Patients will be treated superficially at points away from classic acupoints. The points include bilateral "Forearm" [1 inch lateral to the middle point between HE3 and HE7] , "Upper arm" [1 inch lateral to LU 3 ], and "Lower leg" [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral "Head" [middle point between GB8 and ST8], "Forehead" [middle point between ST8 and GB14], "Neck" [middle point between TB16 and SI17], and "Ear" [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. "De qi" is avoided during needling. The treatment procedure, electric-stimulation, frequency, duration and number of treatment sessions will be the same for the Traditional Acupuncture group. Receives: Other: Acupuncture
Placebo Acupuncture	Placebo comparator	Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the site 1 inch beside the acupoints in order to avoid the acupressure effect. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture. Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment.
Depression state measured by Hamilton Depression Rating Scale (HAMD)
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment.
Depression state measured by Hamilton Anxiety Rating Scale (HAMA)
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment
Subjective report of painful and non-painful somatic symptoms measured by Somatic Symptom Inventory (SSI)
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment.
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Measured: Baseline, 1-week posttreatment and 5-week posttreatment
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 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)
Measured: 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)
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment
Subjects' credibility to the treatment measured by Credibility of treatment rating scale
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline, 1-week posttreatment, and 5-week posttreatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Dec 2013

First posted16 Oct 2012 (estimated)
Study startJan 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01707706
Sponsor's protocol ID: ACUP-004
Status last verified: Dec 2013
First submitted: 22 Feb 2012
Last updated: 13 Dec 2013
Results posted: No
Data monitoring committee: No

Publications

Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.
PubMed 27503746
Yeung WF, Chung KF, Yu BY, Lao L. Response to placebo acupuncture in insomnia: a secondary analysis of three randomized controlled trials. Sleep Med. 2015 Nov;16(11):1372-1376. doi: 10.1016/j.sleep.2015.07.027. Epub 2015 Aug 31.
PubMed 26498238
Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
PubMed 26132682
Chung KF, Yeung WF, Kwok CW, Yu YM. Risk factors associated with adverse events of acupuncture: a prospective study. Acupunct Med. 2014 Dec;32(6):455-62. doi: 10.1136/acupmed-2014-010635. Epub 2014 Sep 30.
PubMed 25271149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Electroacupuncture for Persistent Insomnia Symptoms Associated With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01707706
Acronym / sponsor ID: ACUP-004
Conditions: Insomnia, Depression
Keywords: Insomnia, Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: Jan 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Traditional Acupuncture	Experimental	Other: AcupuncturePatients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Minimal Acupuncture	Active comparator	Other: AcupuncturePatients will be treated superficially at points away from classic acupoints. The points include bilateral "Forearm" [1 inch lateral to the middle point between HE3 and HE7] , "Upper arm" [1 inch lateral to LU 3 ], and "Lower leg" [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral "Head" [middle point between GB8 and ST8], "Forehead" [middle point between ST8 and GB14], "Neck" [middle point between TB16 and SI17], and "Ear" [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. "De qi" is avoided during needling. The treatment procedure, electric-stimulation, frequency, duration and number of treatment sessions will be the same for the Traditional Acupuncture group.
Placebo Acupuncture	Placebo comparator	Other: AcupuncturePlacebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the site 1 inch beside the acupoints in order to avoid the acupressure effect. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureAlso: ElectroacupunctureAcupuncture 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.	Other	Minimal Acupuncture, Placebo Acupuncture, Traditional Acupuncture

Primary outcome

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.

14 secondary outcomes

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)
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Derived from this study: PubMed 27503746Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.
Derived from this study: PubMed 26498238Yeung WF, Chung KF, Yu BY, Lao L. Response to placebo acupuncture in insomnia: a secondary analysis of three randomized controlled trials. Sleep Med. 2015 Nov;16(11):1372-1376. doi: 10.1016/j.sleep.2015.07.027. Epub 2015 Aug 31.
Derived from this study: PubMed 26132682Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
Derived from this study: PubMed 25271149Chung KF, Yeung WF, Kwok CW, Yu YM. Risk factors associated with adverse events of acupuncture: a prospective study. Acupunct Med. 2014 Dec;32(6):455-62. doi: 10.1136/acupmed-2014-010635. Epub 2014 Sep 30.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ka Fai Chung, MBBS principal investigator

The University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Insomnia and Depression, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01707706, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.