Efficacy of EA on Depression Related Insomnia: Study Protocol for a Multicenter RCT

NCT03122080 | Unknown DMC

• 1 other identifier: SHMHTCM Shifen Xu
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.

Conditions

Insomnia Due to Mental Disorder

Keywords

acupuncture; insomnia; depression; antidepressants

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the PSQI score at 8th week post-treatment as the primary outcome, compared with PSQI scores at other time points, to evaluate the effectiveness of acupuncture for depression related insomnia.

  8 week post-treatment

Secondary Outcomes (5)

• Changes of PSQI scores from baseline to 6 month follow-up

  baseline, 4 week post-treatment, 8 week post-treatment, 1 month,3 month, 6 month follow-up

• Actigraphy

  baseline, 4 week post-treatment, 8 week post-treatment

• Hamilton Rating Scale for Depression (HAMD)

  baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up

• Self-rating Anxiety Scale (SAS)

  baseline, 4 week, 8 week post-treatment

• Dose dairy

  baseline, 4 week, 8 week post-treatment, 1 month, 3 month, 6 month follow-up

Other Outcomes (1)

• Adverse effects

  baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up.

Study Arms (3)

Electroacupuncture group

ACTIVE COMPARATOR

electroacupuncture+standard care

Device: Electroacupuncture(EA)

Control A group

PLACEBO COMPARATOR

placebo acupuncture+standard care

Device: Placebo acupuncture

Control B group

OTHER

standard care

Other: Standard care

Interventions

Electroacupuncture(EA) DEVICE

Participants in EA group will receive electroacupuncture treatment. Acupuncture will be applied at Baihui (GV20), Shenting (GV24), Yintang (GV29), bilateral Anmian (EX-HN22), Shenmen (HT7), SanYinjiao (SP6) and Neiguan (PC6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for "Deqi" sensation. The EA apparatus (CMNS6-1, Jianjian Medical Device CO., LTD, China) will be connected to the needles at GV20 and GV29 for 30 minutes and deliver a continuous wave. The frequency will be set at about 30 Hz and the amplitude will be less than 20V. Participants can regularly take the antidepressants or sedative-hypnotics as before during the intervention. Besides, the investigators will strengthen health education about insomnia and depression for the patients.

Electroacupuncture group

Placebo acupuncture DEVICE

Participants in the control A group will receive placebo acupuncture treatment with streitberger needles at the same acupoints as the electroacupuncture group. When the tip of the blunt needles touches to the skin, the patient will get a pricking sensation but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set beside the patients, with no connection to the needles. Inform the patients when removing the needles after 30 minutes. Use the dry cotton ball to press the acupoints so that patients can feel the withdrawal of the 'needles'. Same health education and regular administration of antidepressants or sedative-hypnotics will be given to the participants during the intervention.

Control A group

Standard care OTHER

Participants in the control B group will keep their standard medical care for the first 8 weeks. Participants will take their regular antidepressants and the sedative-hypnotics during the whole intervention period. Same health education will be conducted as well for the participants. And after waiting for two months, these patients will be treated with the same electroacupuncture treatment as the EA group.

Control B group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18-70;
• Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
• Participants whose HAMD score is 20-35;
• Participants who have complaint about insomnia at the first visit to the doctor;
• Participants whose PSQI score is more than 7;
• Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

You may not qualify if:

• Participants with secondary depressive disorders caused by organic diseases, medicine, or psychotic disorders including schizophrenia, etc;
• Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases;
• Participants with alcohol abuse or drug dependence;
• Participants who refuse to wear the Actigraphy during the trial;
• Pregnant or lactating women.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead
• Shanghai University of Traditional Chinese Medicine: collaborator
• Changhai Hospital: collaborator
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

RECRUITING

Related Publications (2)

• Yin X, Li W, Liang T, Lu B, Yue H, Li S, Zhong VW, Zhang W, Li X, Zhou S, Mi Y, Wu H, Xu S. Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220563. doi: 10.1001/jamanetworkopen.2022.20563.

  PMID: 35797047 DERIVED

• Yin X, Dong B, Liang T, Yin P, Li X, Lin X, Zhou S, Qian X, Lao L, Xu S. Efficacy and safety of electroacupuncture on treating depression-related insomnia: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e021484. doi: 10.1136/bmjopen-2018-021484.

  PMID: 31005904 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Interventions

Electroacupuncture; Standard of Care

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shifen Xu, PhD

  Shanghai Municipal Hospital of TCM

  STUDY DIRECTOR

• Xia Li

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

• Shuang Zhou

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shifen Xu, PhD

CONTACT

+8613761931393; xu_teacher2006@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 20, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 30, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

CN (1)