Top

Trials

Published in:

Open Access 01-12-2022 | Insomnia | Study protocol

The effects of acupuncture on psychological symptoms in patients with insomnia: study protocol for a randomized controlled trial

Authors: Lifen Wang, Ruisen Wang, Yanling Yao, Xue Bai, Gang Sheng

Published in: Trials | Issue 1/2022

Abstract

Background

Insomnia is a common sleep-related condition that includes dissatisfaction with sleep quality, difficulty in initiating or maintaining sleep, and early morning waking. Insomnia can affect daytime functioning by causing fatigue, depression, and anxiety. Medications are the most common method for the management of insomnia but can cause adverse effects, including psychological and physical dependence, residual daytime sedation, and cognitive impairment. Acupuncture is a common traditional Chinese therapy. It has been used in the treatment of insomnia, depression, and anxiety in China. However, there are no high-quality studies focusing on acupuncture for insomnia, especially for depression and anxiety due to insomnia. Therefore, we have designed a randomized controlled trial (RCT) involving a placebo control to ensure blinding of participants to investigate the effects of acupuncture on insomnia in improving sleep quality and psychosocial symptoms.

Methods

We have designed a single-center, parallel-group, single-blinded RCT. A total of 252 participants who meet the eligibility criteria will be randomly allocated into a manual acupuncture group or sham acupuncture group in a 1:1 ratio. All participants will receive 24 sessions of acupuncture (30 min per session, three sessions per week for 8 weeks). Participants will be assessed using the Pittsburgh Sleep Quality Index score, self-assessment anxiety scale, self-assessment depression scale, and Medical Outcomes Study 36-Item Short-Form Health Survey at baseline and 8 weeks. All analyses will be based on an intention-to-treat principle. The results will be published in an international peer-reviewed journal.

Discussion

The results of this study are expected to clarify the effects of acupuncture on sleep quality and psychosocial symptoms in patients with insomnia. This will contribute to the clinical practice of acupuncture in the management of insomnia.

Trial registration

Chinese Clinical Trail Registry ChiCTR2100049172. Registered on 24 July 2021.

Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–10.PubMedPubMedCentral

Buysse DJ. Insomnia. JAMA. 2013;309(7):706–16. https://doi.org/10.1001/jama.2013.193.CrossRefPubMedPubMedCentral

Bianchi MT. Chronic insomnia. Semin Neurol. 2017;37(4):433–8. https://doi.org/10.1055/s-0037-1605344.CrossRefPubMed

Cao XL, Wang SB, Zhong BL, Zhang L, Ungvari GS, Ng CH, et al. The prevalence of insomnia in the general population in China: a meta-analysis. PLoS One. 2017;12(2):e0170772. https://doi.org/10.1371/journal.pone.0170772.CrossRefPubMedPubMedCentral

Cox RC, Olatunji BO. A systematic review of sleep disturbance in anxiety and related disorders. J Anxiety Disord. 2016;37:104–29. https://doi.org/10.1016/j.janxdis.2015.12.001.CrossRefPubMed

Barry V, Stout ME, Lynch ME, Mattis S, Tran DQ, Antun A, et al. The effect of psychological distress on health outcomes: a systematic review and meta-analysis of prospective studies. J Health Psychol. 2020;25(2):227–39. https://doi.org/10.1177/1359105319842931.CrossRefPubMed

Kobayashi Y, Kondo N. Organizational justice, psychological distress, and stress-related behaviors by occupational class in female Japanese employees. PLoS One. 2019;14(4):e0214393. https://doi.org/10.1371/journal.pone.0214393.CrossRefPubMedPubMedCentral

Abad VC, Guilleminault C. Insomnia in elderly patients: recommendations for pharmacological management. Drugs Aging. 2018;35(9):791–817. https://doi.org/10.1007/s40266-018-0569-8.CrossRefPubMed

Chong Y, Fryer CD, Gu Q. Prescription sleep aid use among adults: United States, 2005–2010. NCHS Data Brief. 2013;127:1–8.

10.

Hirst A, Sloan R. Benzodiazepines and related drugs for insomnia in palliative care. Cochrane Database Syst Rev. 2013;11(4):CD003346. https://doi.org/10.1002/14651858.CD003346.pub2.CrossRef

11.

Qaseem A, Kansagara D, Forciea MA, Cooke M. Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125–33. https://doi.org/10.7326/M15-2175.CrossRefPubMed

12.

Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487–504. https://doi.org/10.5664/jcsm.27286.CrossRefPubMedPubMedCentral

13.

Yang JL, Zhang R, Du L, et al. Clinical observation on the neurotransmitters regulation in patients of insomnia differentiated as yang deficiency pattern treated with warm acupuncture and auricular point sticking therapy. Zhongguo Zhen Jiu Chin Acupunct Moxibustion. 2014;34(12):1165–8.

14.

Liu Z, Chen X, Gao Y, Sun S, Yang L, Yang Q, et al. Involvement of GluR2 up-regulation in neuroprotection by electroacupuncture pretreatment via cannabinoid CB1 receptor in mice. Sci Rep. 2015;5(1):9490. https://doi.org/10.1038/srep09490.CrossRefPubMedPubMedCentral

15.

He W, Li M, Zuo L, Wang M, Jiang L, Shan H, et al. Acupuncture for treatment of insomnia: an overview of systematic reviews. Complement Ther Med. 2019;42:407–16. https://doi.org/10.1016/j.ctim.2018.12.020.CrossRefPubMed

16.

Shergis JL, Ni X, Jackson ML, Zhang AL, Guo X, Li Y, et al. A systematic review of acupuncture for sleep quality in people with insomnia. Complement Ther Med. 2016;26:11–20. https://doi.org/10.1016/j.ctim.2016.02.007.CrossRefPubMed

17.

Dong B, Chen Z, Yin X, Li D, Ma J, Yin P, et al. The efficacy of acupuncture for treating depression-related insomnia compared with a control group: a systematic review and meta-analysis. Biomed Res Int. 2017;2017:9614810. https://doi.org/10.1155/2017/9614810.CrossRefPubMedPubMedCentral

18.

Association APAP. Diagnostic and statistical manual of mental disorders DSM- IV. JAMA. 2000;48:126–9.

19.

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. https://doi.org/10.1016/0165-1781(89)90047-4.CrossRefPubMed

20.

Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, et al. Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: a randomized clinical trial. JAMA. 2017;317(24):2502–14. https://doi.org/10.1001/jama.2017.7217.CrossRefPubMedPubMedCentral

21.

Ware JEJ, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). Conceptual framework and item selection. Med Care. 1992; 30(6):473–483, https://doi.org/10.1097/00005650-199206000-00002.

Title: The effects of acupuncture on psychological symptoms in patients with insomnia: study protocol for a randomized controlled trial
Authors: Lifen Wang
Ruisen Wang
Yanling Yao
Xue Bai
Gang Sheng
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Insomnia
Acupuncture
Affective Disorder
Affective Disorder
Anxiety
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06078-2

At a glance: The STEP trials

Springer Medicine

The effects of acupuncture on psychological symptoms in patients with insomnia: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial

The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial

Australasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopic surgery for management of malignant pleural effusion

Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial

Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial