Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

Yin, Xuan; Xu, Jian; Dong, Bo; Ma, Jie; Chen, Zeqin; Yin, Ping; Wu, Jiang; Zhu, Bao Li; Cao, Yan; Zheng, Huimin; Lao, Lixing

doi:10.1155/2016/1069597

Cited by 14 publications

(12 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For instance, we will make reasonable arrangements for treatment time and consultation time by phone or e-mail to increase their attendance rate. Besides, free acupuncture treatment will be promised by acupuncturists if the patients are not satisfied with the results of their treatment during the trial [26]. And participants will get adequate transportation allowance if they have completed all the treatment and follow-up.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Yue

Zhou

et al. 2020

Trials

Self Cite

View full text Add to dashboard Cite

Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

show abstract

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Yue

Zhou

et al. 2020

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

“…According to the main treatment principles of regulating the Governor Vessel with acupuncture, we have selected acupoints GV20 and GV29 in GV for EA to improve the curative effect for treating sub-threshold depression. In terms of imageology, EA at acupoint GV20 was previously found to modulate the default pattern network for patients with depression (45). We chose GV20 and GV29, and the bilateral acupoints GB13, because their stimulating area includes the prefrontal cortex.…”

Section: Discussionmentioning

confidence: 99%

Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial

et al. 2020

View full text Add to dashboard Cite

Background: Sub-threshold depression is common and could impair function, as well as increase the risk of developing major depression. Despite evidence of efficacy for electroacupuncture (EA) and counseling in the treatment of sub-threshold depression, the sample size is insufficient and the level of evidence remains low. This study aims to evaluate the effectiveness of sub-threshold depression treatments by comparing the treatment effects among EA, counseling, and combination therapy, as well as to further study their mechanism. Methods: This study is a multicenter, randomized, single blind clinical trial that will be conducted in settings at four clinical centers in China. The randomized controlled trial (RCT) will examine the effectiveness of EA intervention, compared with counseling and combination therapy. A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited. The participants will be randomly assigned to receive the above treatments. The interventions will be delivered over a 6-week period (EA: 3 times a week for 6 weeks; 30 min a session. Counseling: once a week for 6 weeks; 50-60 min a session). The primary outcome measure will be the HAMD-17; BDI-II. The secondary outcome measures will be: Selfrating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI). The assessments will occur at baseline, 2, 4, and 6 weeks and a follow-up period. Recruitment will commence in March 2020 and is anticipated to occur over a 2-year period.

show abstract

“…For instance, we will make reasonable arrangements for treatment time and consultation time by phone or e-mail to increase their attendance rate and free acupuncture treatment will be promised by acupuncturists if the patients are not satisfied with the results of their treatment during the trial [26].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

Yue

Zhou

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

Background : Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method : This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). The primary outcome will be assessed at baseline, week 4, week 8, week 12 and week 20. The secondary outcomes will only be assessed at baseline and week 8. Discussion : This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

show abstract

Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

Cited by 14 publications

References 31 publications

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial

Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

Contact Info

Product

Resources

About