Feasibility of a Personalized SMS Intervention for Insomnia
NCT ID: NCT05108194
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2021-11-15
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Intervention
Participants (N=50) who endorse insomnia will be followed for 8 weeks. All participants will be asked to download a separate app to passively monitor sleep that will inform the personalized messages. Participants will also be asked to respond to daily prompts in order to validate the passive sleep data. The study includes two phases: (1) a training and validation phase and (2) an intervention phase. During phase 1, participants' sleep habits and other behaviors will be monitored for two weeks in order to validate and optimize the SMS personalized sleep intervention (PSI). In phase 2, participants will be transitioned to the intervention phase of the study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unable to read or write in English
* do not own a Smart Phone
18 Years
ALL
No
Sponsors
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University of Missouri, St. Louis
OTHER
Responsible Party
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Chelsey Wilks
Assistant Professor
Principal Investigators
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Chelsey R Wilks, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri, St. Louis
Locations
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University of Missouri-St Louis
St Louis, Missouri, United States
Countries
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Central Contacts
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References
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Mai E, Buysse DJ. Insomnia: Prevalence, Impact, Pathogenesis, Differential Diagnosis, and Evaluation. Sleep Med Clin. 2008;3(2):167-174. doi: 10.1016/j.jsmc.2008.02.001. No abstract available.
Dolsen EA, 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.
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.
Cai GH, Theorell-Haglow J, Janson C, Svartengren M, Elmstahl 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.
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.
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. doi: 10.1097/01.psy.0000030391.09558.a3.
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.
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.
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. doi: 10.1093/sleep/31.4.489.
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.
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.
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.
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. doi: 10.1093/sleep/29.12.1643.
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. doi: 10.1016/j.invent.2016.06.003. Epub 2016 Jun 16.
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.
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
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.
Hebert 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.
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.
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.
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.
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.
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. doi: 10.1016/0165-1781(89)90047-4.
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.
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.
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. doi: 10.1046/j.1525-1497.2001.016009606.x.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
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
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
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
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
Other Identifiers
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UMissouriSL
Identifier Type: -
Identifier Source: org_study_id
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