Study Summary
This trial is testing whether a specific protocol of auricular acupuncture can help people with sleep disturbances, and whether it can also decrease severity of anxiety, depression, pain and improve sleep and social functioning in people with mental health disorders.
- Sleep Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: visit 10 (23-24 weeks)
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Standard treatment from PCM or Mental Health or both + auricular acupuncture
1 of 2
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
1 of 2
Experimental Treatment
Non-Treatment Group
316 Total Participants · 2 Treatment Groups
Primary Treatment: Auricular acupuncture · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- “Nonpharmacological Interventions for Insomnia: A Meta-analysis of Treatment Efficacy”. 1994. “Nonpharmacological Interventions for Insomnia: A Meta-analysis of Treatment Efficacy”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.151.8.1172.
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- Engel, Charles C., Elizabeth H. Cordova, David M. Benedek, Xian Liu, Kristie L. Gore, Christine Goertz, Michael C. Freed, Cindy Crawford, Wayne B. Jonas, and Robert J. Ursano. 2014. “Randomized Effectiveness Trial of a Brief Course of Acupuncture for Posttraumatic Stress Disorder”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mlr.0000000000000237.
- Mason, Elizabeth C., and Allison G. Harvey. 2014. “Insomnia Before and After Treatment for Anxiety and Depression”. Journal of Affective Disorders. Elsevier BV. doi:10.1016/j.jad.2014.07.020.
- Talbot, Lisa S., Shira Maguen, Thomas J. Metzler, Martha Schmitz, Shannon E. McCaslin, Anne Richards, Michael L. Perlis, et al.. 2014. “Cognitive Behavioral Therapy for Insomnia in Posttraumatic Stress Disorder: A Randomized Controlled Trial”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.3408.
- Marmar, Charles R., William Schlenger, Clare Henn-Haase, Meng Qian, Emily Purchia, Meng Li, Nida Corry, et al.. 2015. “Course of Posttraumatic Stress Disorder 40 Years After the Vietnam War”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2015.0803.
- Smyth, Aisling, Mark Jenkins, Melissa Dunham, Yvonne Kutzer, Shahrad Taheri, and Lisa Whitehead. 2020. “Systematic Review of Clinical Practice Guidelines to Identify Recommendations for Sleep in Type 2 Diabetes Mellitus Management”. Diabetes Research and Clinical Practice. Elsevier BV. doi:10.1016/j.diabres.2020.108532.
- Hou, Yuchao, Lumin Liu, Xiaotong Chen, Qi Li, and Jing Li. 2020. “Association Between Circadian Disruption and Diseases: A Narrative Review”. Life Sciences. Elsevier BV. doi:10.1016/j.lfs.2020.118512.
- Leso, Veruscka, Paola Gervetti, Sara Mauro, Maria C. Macrini, Maria L. Ercolano, and Ivo Iavicoli. 2020. “Shift Work and Migraine: A Systematic Review”. Journal of Occupational Health. Wiley. doi:10.1002/1348-9585.12116.
- Singaraju, Raj C, Janet N Myers, Jill T Owczarzak, and Andrea C Gielen. 2018. “Combat Readiness, Harm Aversion, and Promotion Eligibility: A Qualitative Study of U.S. Servicemembers Views on Tobacco Use and Control in the Military”. Military Medicine. Oxford University Press (OUP). doi:10.1093/milmed/usy181.
- Van Camp, Roscoe O.. 2009. “Zolpidem in Fatigue Management for Surge Operations of Remotely Piloted Aircraft”. Aviation, Space, and Environmental Medicine. Aerospace Medical Association. doi:10.3357/asem.2460.2009.
- King, Heather C., Dennis L. Spence, Anita H. Hickey, Paul Sargent, Ronald Elesh, and Cynthia D. Connelly. 2015. “Auricular Acupuncture for Sleep Disturbance in Veterans with Post-traumatic Stress Disorder: A Feasibility Study”. Military Medicine. Oxford University Press (OUP). doi:10.7205/milmed-d-14-00451.
- Yu, Lan, Daniel J. Buysse, Anne Germain, Douglas E. Moul, Angela Stover, Nathan E. Dodds, Kelly L. Johnston, and Paul A. Pilkonis. 2012. “Development of Short Forms from the PROMIS™ Sleep Disturbance and Sleep-related Impairment Item Banks”. Behavioral Sleep Medicine. Informa UK Limited. doi:10.1080/15402002.2012.636266.
- Oosterman, Johanneke E, Suzan Wopereis, and Andries Kalsbeek. 2020. “The Circadian Clock, Shift Work, and Tissue-specific Insulin Resistance”. Endocrinology. The Endocrine Society. doi:10.1210/endocr/bqaa180.
- Kang, Jiwon, Wonjung Noh, and Youngjin Lee. 2020. “Sleep Quality Among Shift-work Nurses: A Systematic Review and Meta-analysis”. Applied Nursing Research. Elsevier BV. doi:10.1016/j.apnr.2019.151227.
- Hoge, Charles W., Carl A. Castro, Stephen C. Messer, Dennis McGurk, Dave I. Cotting, and Robert L. Koffman. 2004. “Combat Duty in Iraq and Afghanistan, Mental Health Problems, and Barriers to Care”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa040603.
- A. Caldwell, John, Joseph J. Knapik, and Harris R. Lieberman. 2017. “Trends and Factors Associated with Insomnia and Sleep Apnea in All United States Military Service Members from 2005 to 2014”. Journal of Sleep Research. Wiley. doi:10.1111/jsr.12543.
- Colvonen, Peter J., Laura D. Straus, Carl Stepnowsky, Michael J. McCarthy, Lizabeth A. Goldstein, and Sonya B. Norman. 2018. “Recent Advancements in Treating Sleep Disorders in Co-occurring PTSD”. Current Psychiatry Reports. Springer Science and Business Media LLC. doi:10.1007/s11920-018-0916-9.
- Koffel, Erin, and Leah Farrell-Carnahan. 2014. “Feasibility and Preliminary Real-world Promise of a Manualized Group-based Cognitive Behavioral Therapy for Insomnia Protocol for Veterans”. Military Medicine. Oxford University Press (OUP). doi:10.7205/milmed-d-13-00455.
- Engdahl, Brian, Thomas N. Dikel, Raina Eberly, and Arthur Blank Jr.. 1997. “Posttraumatic Stress Disorder in a Community Group of Former Prisoners of War: A Normative Response to Severe Trauma”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.154.11.1576.
- Järnefelt, Heli, Mikko Härmä, Mikael Sallinen, Jussi Virkkala, Teemu Paajanen, Kari-Pekka Martimo, and Christer Hublin. 2019. “Cognitive Behavioural Therapy Interventions for Insomnia Among Shift Workers: RCT in an Occupational Health Setting”. International Archives of Occupational and Environmental Health. Springer Science and Business Media LLC. doi:10.1007/s00420-019-01504-6.
- “National Institutes of Health State of the Science Conference Statement”. 2005. “National Institutes of Health State of the Science Conference Statement”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/28.9.1049.
- Margolies, Skye Ochsner, Bruce Rybarczyk, Scott R. Vrana, David J. Leszczyszyn, and John Lynch. 2013. “Efficacy of a Cognitive-behavioral Treatment for Insomnia and Nightmares in Afghanistan and Iraq Veterans with PTSD”. Journal of Clinical Psychology. Wiley. doi:10.1002/jclp.21970.
- Brown, Cary A., Robyn Berry, and Ashley Schmidt. 2013. “Sleep and Military Members: Emerging Issues and Nonpharmacological Intervention”. Sleep Disorders. Hindawi Limited. doi:10.1155/2013/160374.
- Mittal, Dinesh, Karen L. Drummond, Dean Blevins, Geoffrey Curran, Patrick Corrigan, and Greer Sullivan. 2013. “Stigma Associated with PTSD: Perceptions of Treatment Seeking Combat Veterans.”. Psychiatric Rehabilitation Journal. American Psychological Association (APA). doi:10.1037/h0094976.
- Neylan, Thomas C., Charles R. Marmar, Thomas J. Metzler, Daniel S. Weiss, Douglas F. Zatzick, Kevin L. Delucchi, Roger M. Wu, and Frank B. Schoenfeld. 1998. “Sleep Disturbances in the Vietnam Generation: Findings from a Nationally Representative Sample of Male Vietnam Veterans”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.155.7.929.
- Bei, Bei, Lauren D. Asarnow, Andrew Krystal, Jack D. Edinger, Daniel J. Buysse, and Rachel Manber. 2018. “Treating Insomnia in Depression: Insomnia Related Factors Predict Long-term Depression Trajectories.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/ccp0000282.
- Funk, Janette L., and Ronald D. Rogge. 2007. “Testing the Ruler with Item Response Theory: Increasing Precision of Measurement for Relationship Satisfaction with the Couples Satisfaction Index.”. Journal of Family Psychology. American Psychological Association (APA). doi:10.1037/0893-3200.21.4.572.
- Connor, K. M., and J. R.T. Davidson. 2001. “SPRINT: A Brief Global Assessment of Post-traumatic Stress Disorder”. International Clinical Psychopharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004850-200109000-00005.
- Mohd Azmi, Nor Amira Syahira, Norsham Juliana, Nur Islami Mohd Fahmi Teng, Sahar Azmani, Srijit Das, and Nadia Effendy. 2020. “Consequences of Circadian Disruption in Shift Workers on Chrononutrition and Their Psychosocial Well-being”. International Journal of Environmental Research and Public Health. MDPI AG. doi:10.3390/ijerph17062043.
- Moore, Brian A, Lynn M Tison, Javier G Palacios, Alan L Peterson, and Vincent Mysliwiec. 2021. “Incidence of Insomnia and Obstructive Sleep Apnea in Active Duty United States Military Service Members”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/zsab024.
- Talbot, Lisa S., Shira Maguen, Thomas J. Metzler, Martha Schmitz, Shannon E. McCaslin, Anne Richards, Michael L. Perlis, et al.. 2014. “Cognitive Behavioral Therapy for Insomnia in Posttraumatic Stress Disorder: A Randomized Controlled Trial”. Sleep. Oxford University Press (OUP). doi:10.5665/sleep.3408.
- Gellis, Les A., and Philip R. Gehrman, "Cognitive Behavioral Treatment for Insomnia in Veterans with Long-Standing Posttraumatic Stress Disorder: A Pilot Study," Journal of Aggression, Maltreatment and Trauma, Vol. 20, No. 8, 2011
- Grant S, Colaiaco B, Motala A, Shanman RM, Sorbero ME, Hempel S. Needle acupuncture for posttraumatic stress disorder (PTSD): A systematicreview. Santa Monica, CA: RAND Corporation, 15 March 2017.i-xxii, 1-94 pp. 2017:i-xxii, 1-94.
- Kulka RA, Schlenger WE, Fairbank JA, et al. Trauma and the Vietnam War Generation: Report of Findings From the National Vi etnam VeteransReadjustment Study. New York, NY: Brunner/Mazel; 1990.
- National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep. 2005 Sep;28(9):1049-57. doi: 10.1093/sleep/28.9.1049. No abstract available.
- Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
- Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;:
- Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
- Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
- Van Camp RO. Zolpidem in fatigue management for surge operations of remotely piloted aircraft. Aviat Space Environ Med. 2009 Jun;80(6):553-5. doi: 10.3357/asem.2460.2009.
- Connor KM, Davidson JR. SPRINT: a brief global assessment of post-traumatic stress disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):279-84. doi: 10.1097/00004850-200109000-00005.
- Mohd Azmi NAS, Juliana N, Mohd Fahmi Teng NI, Azmani S, Das S, Effendy N. Consequences of Circadian Disruption in Shift Workers on Chrononutrition and their Psychosocial Well-Being. Int J Environ Res Public Health. 2020 Mar 19;17(6):2043. doi: 10.3390/ijerph17062043.
- Engdahl B, Dikel TN, Eberly R, Blank A Jr. Posttraumatic stress disorder in a community group of former prisoners of war: a normative response to severe trauma. Am J Psychiatry. 1997 Nov;154(11):1576-81. doi: 10.1176/ajp.154.11.1576.
- Oosterman JE, Wopereis S, Kalsbeek A. The Circadian Clock, Shift Work, and Tissue-Specific Insulin Resistance. Endocrinology. 2020 Dec 1;161(12):bqaa180. doi: 10.1210/endocr/bqaa180.
- Hou Y, Liu L, Chen X, Li Q, Li J. Association between circadian disruption and diseases: A narrative review. Life Sci. 2020 Dec 1;262:118512. doi: 10.1016/j.lfs.2020.118512. Epub 2020 Sep 30.
- Moore BA, Tison LM, Palacios JG, Peterson AL, Mysliwiec V. Incidence of insomnia and obstructive sleep apnea in active duty United States military service members. Sleep. 2021 Jul 9;44(7):zsab024. doi: 10.1093/sleep/zsab024.
- Colvonen PJ, Straus LD, Stepnowsky C, McCarthy MJ, Goldstein LA, Norman SB. Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. Curr Psychiatry Rep. 2018 Jun 21;20(7):48. doi: 10.1007/s11920-018-0916-9.
- Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL, Wu RM, Schoenfeld FB. Sleep disturbances in the Vietnam generation: findings from a nationally representative sample of male Vietnam veterans. Am J Psychiatry. 1998 Jul;155(7):929-33. doi: 10.1176/ajp.155.7.929.
- Paul Crawford 2022. "Auricular Acupuncture for Sleep Disturbances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956341.
Frequently Asked Questions
What is the aggregate figure of participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study's recruitment period began on May 1st of 2022 and was recently updated on June 6th 2022. A total of 316 participants are needed for the trial at a single site." - Anonymous Online Contributor
Is the enrollment process for this trial still available?
"As detailed on clinicaltrials.gov, the recruitment process for this trial is in full swing and has been so since May 1st 2022 when it was first posted. The study's information was last edited on June 6th 2022." - Anonymous Online Contributor