Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05108194
Other study ID # UMissouriSL
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 15, 2021
Est. completion date June 1, 2022

Study information

Verified date April 2022
Source University of Missouri, St. Louis
Contact Chelsey R Wilks, PhD
Phone (314) 516-5383
Email chelseywilks@umsl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research is to establish a proof of concept for optimizing and evaluating a personalized SMS intervention based for individuals with chronic sleep problems.


Description:

Insomnia is a pervasive disorder affecting approximately 10-40% of the U.S. population in a given year. In addition, insomnia has been identified as a transdiagnostic symptom that cuts across numerous other psychological disorders. Interventions that target disordered sleep may attenuate symptomatic distress for a multitude of psychological disorders, making it a potentially potent intervention target with broad public health potential. Despite the ubiquity of the problem, only a fraction of individuals who could benefit actually receive the most effective intervention for insomnia, cognitive behavioral therapy for insomnia (CBT-I). Emerging research has pointed to the possibility of monitoring behavior and delivering personalized interventions to specific individuals via mobile devices. Personalized and adaptive interventions delivered via Short Message Service (SMS) provide a relatively simple solution to prompt individuals to engage in personalized interventions outside the context of opening or downloading a mobile mental health app. The content of text messages have the capacity to modulate behavior via prompts, motivational messages, and "nudges." By using brief, motivational messages based on evidence-based treatment for sleep (e.g. CBT-I), there is the potential to reduce dysfunctional sleep patterns at scale.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - clinical insomnia (defined by scoring = 15 on the insomnia severity index) Exclusion Criteria: - under 18 y.o. - unable to read or write in English - do not own a Smart Phone

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS Personalized Sleep Intervention
All participants will be enrolled in the intervention to evaluate the feasibility and acceptability of the SMS-PSI. After the data training and validation phase, participants will be provided with at least one and up to three daily text messages that offer users a specific strategy based on strategies from CBTi. All participants will have access to a "user dashboard", which is a web-app that includes personalized sleep-tracking information and the opportunity to customize their messaging. The person-level acceptability and adherence to the sleep strategies will be evaluated via self-report endorsement from daily diary and whether users added suggestions to their calendars. Both adherence and acceptability will be collected and integrated with the selection algorithm to optimize subsequent SMS suggestions.

Locations

Country Name City State
United States University of Missouri-St Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri, St. Louis

Country where clinical trial is conducted

United States, 

References & Publications (31)

Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability Scale. Int J Hum-Comput Interact. 2008;24(6):574-594. http://doi:10.1080/10447310802205776

Britton PC, McKinney JM, Bishop TM, Pigeon WR, Hirsch JK. Insomnia and risk for suicidal behavior: A test of a mechanistic transdiagnostic model in veterans. J Affect Disord. 2019 Feb 15;245:412-418. doi: 10.1016/j.jad.2018.11.044. Epub 2018 Nov 5. — View Citation

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 May;28(2):193-213. — View Citation

Cai GH, Theorell-Haglöw J, Janson C, Svartengren M, Elmståhl S, Lind L, Lindberg E. Insomnia symptoms and sleep duration and their combined effects in relation to associations with obesity and central obesity. Sleep Med. 2018 Jun;46:81-87. doi: 10.1016/j.sleep.2018.03.009. Epub 2018 Apr 3. — View Citation

Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4. — View Citation

Dolsen MR, Asarnow LD, Harvey AG. Insomnia as a transdiagnostic process in psychiatric disorders. Curr Psychiatry Rep. 2014 Sep;16(9):471. doi: 10.1007/s11920-014-0471-y. Review. — View Citation

Fortier-Brochu E, Beaulieu-Bonneau S, Ivers H, Morin CM. Insomnia and daytime cognitive performance: a meta-analysis. Sleep Med Rev. 2012 Feb;16(1):83-94. doi: 10.1016/j.smrv.2011.03.008. Epub 2011 Jun 1. — View Citation

Gradisar M, Lack L, Richards H, Harris J, Gallasch J, Boundy M, Johnston A. The Flinders Fatigue Scale: preliminary psychometric properties and clinical sensitivity of a new scale for measuring daytime fatigue associated with insomnia. J Clin Sleep Med. 2007 Dec 15;3(7):722-8. — View Citation

Gratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. J Psychopathol Behav Assess. 2004;26(1):41-54. http://doi:10.1023/B:JOBA.0000007455.08539.94

Hardeman W, Houghton J, Lane K, Jones A, Naughton F. A systematic review of just-in-time adaptive interventions (JITAIs) to promote physical activity. Int J Behav Nutr Phys Act. 2019 Apr 3;16(1):31. doi: 10.1186/s12966-019-0792-7. — View Citation

Hébert ET, Ra CK, Alexander AC, Helt A, Moisiuc R, Kendzor DE, Vidrine DJ, Funk-Lawler RK, Businelle MS. A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Mar 9;22(3):e16907. doi: 10.2196/16907. — View Citation

Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. J Couns Psychol. 1989;36(2):223-233. http://doi:10.1037/0022-0167.36.2.223

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4. Review. — View Citation

Lattie EG, Schueller SM, Sargent E, Stiles-Shields C, Tomasino KN, Corden ME, Begale M, Karr CJ, Mohr DC. Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps. Internet Interv. 2016 May;4(2):152-158. Epub 2016 Jun 16. — View Citation

Lau PW, Lau EY, Wong del P, Ransdell L. A systematic review of information and communication technology-based interventions for promoting physical activity behavior change in children and adolescents. J Med Internet Res. 2011 Jul 13;13(3):e48. doi: 10.2196/jmir.1533. Review. — View Citation

Mai E, Buysse DJ. Insomnia: Prevalence, Impact, Pathogenesis, Differential Diagnosis, and Evaluation. Sleep Med Clin. 2008;3(2):167-174. — View Citation

Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. — View Citation

Margolies SO, Rybarczyk B, Vrana SR, Leszczyszyn DJ, Lynch J. Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. J Clin Psychol. 2013 Oct;69(10):1026-42. doi: 10.1002/jclp.21970. Epub 2013 Apr 29. — View Citation

Mcmurtry SL, Hudson WW. The Client Satisfaction Inventory: Results of an Initial Validation Study. Res Soc Work Pract. 2000;10(5):644-663. http://doi:10.1177/104973150001000506

Mitchell MD, Gehrman P, Perlis M, Umscheid CA. Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review. BMC Fam Pract. 2012 May 25;13:40. doi: 10.1186/1471-2296-13-40. Review. — View Citation

Morin CM, Rodrigue S, Ivers H. Role of stress, arousal, and coping skills in primary insomnia. Psychosom Med. 2003 Mar-Apr;65(2):259-67. — View Citation

Saeb S, Cybulski TR, Schueller SM, Kording KP, Mohr DC. Authorship Correction: Scalable Passive Sleep Monitoring Using Mobile Phones: Opportunities and Obstacles. J Med Internet Res. 2017 Apr 28;19(4):e143. doi: 10.2196/jmir.7932. — View Citation

Schroeder J, Suh J, Wilks C, Czerwinski M, Munson SA, Fogarty J, Althoff T. Data-Driven Implications for Translating Evidence-Based Psychotherapies into Technology-Delivered Interventions. Int Conf Pervasive Comput Technol Healthc. 2020 May;2020:274-287. doi: 10.1145/3421937.3421975. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Stinson K, Tang NK, Harvey AG. Barriers to treatment seeking in primary insomnia in the United Kingdom: a cross-sectional perspective. Sleep. 2006 Dec;29(12):1643-6. — View Citation

Szaszi B, Palinkas A, Palfi B, Szollosi A, Aczel B. A Systematic Scoping Review of the Choice Architecture Movement: Toward Understanding When and Why Nudges Work: Systematic Scoping Review of the Nudge Movement. J Behav Decis Mak. 2018;31(3):355-366. http://doi:10.1002/bdm.2035

Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841. Review. — View Citation

Waite F, Myers E, Harvey AG, Espie CA, Startup H, Sheaves B, Freeman D. Treating Sleep Problems in Patients with Schizophrenia. Behav Cogn Psychother. 2016 May;44(3):273-87. doi: 10.1017/S1352465815000430. Epub 2015 Jul 30. — View Citation

Wilks CR, Lungu A, Ang SY, Matsumiya B, Yin Q, Linehan MM. A randomized controlled trial of an Internet delivered dialectical behavior therapy skills training for suicidal and heavy episodic drinkers. J Affect Disord. 2018 May;232:219-228. doi: 10.1016/j.jad.2018.02.053. Epub 2018 Feb 17. — View Citation

Wilks CR, Yin Q, Zuromski KL. User Experience Affects Dropout from Internet-Delivered Dialectical Behavior Therapy. Telemed J E Health. 2020 Jun;26(6):794-797. doi: 10.1089/tmj.2019.0124. Epub 2019 Sep 6. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other PROMIS: Sleep related impairment Sleep-related functional impairment 8 weeks
Other Flinders Fatigue Scale Fatigue 8 weeks
Other Patient Health questionnaire 8 item Depression 8 weeks
Other Difficulties in Emotion Regulation Scale Emotion regulation 8 weeks
Primary Insomnia Severity Index Insomnia severity 8 weeks
Secondary System Usability Scale Usability of the intervention 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A