Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT05108194
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2021-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Personalized SMS Intervention for Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All participants will be enrolled in the intervention and all participants and study staff will be aware.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will enroll in the intervention after a two week assessment phase.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PROMIS: Sleep related impairment', 'timeFrame': '8 weeks', 'description': 'Sleep-related functional impairment'}, {'measure': 'Flinders Fatigue Scale', 'timeFrame': '8 weeks', 'description': 'Fatigue'}, {'measure': 'Patient Health questionnaire 8 item', 'timeFrame': '8 weeks', 'description': 'Depression'}, {'measure': 'Difficulties in Emotion Regulation Scale', 'timeFrame': '8 weeks', 'description': 'Emotion regulation'}], 'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': '8 weeks', 'description': 'Insomnia severity'}], 'secondaryOutcomes': [{'measure': 'System Usability Scale', 'timeFrame': '8 weeks', 'description': 'Usability of the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Sleep'], 'conditions': ['Insomnia', 'Sleep Disorder']}, 'referencesModule': {'references': [{'pmid': '19122760', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25030972', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30423469', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29773216', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19962922', 'type': 'BACKGROUND', '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.'}, {'pmid': '12651993', 'type': 'BACKGROUND', '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. doi: 10.1097/01.psy.0000030391.09558.a3.'}, {'pmid': '21636297', 'type': 'BACKGROUND', '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.'}, {'pmid': '23629959', 'type': 'BACKGROUND', 'citation': 'Margolies SO, Rybarczyk B, Vrana SR, Leszczyszyn DJ, Lynch J. 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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.'}, {'pmid': '22631616', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17252896', 'type': 'BACKGROUND', '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. doi: 10.1093/sleep/29.12.1643.'}, {'pmid': '27398319', 'type': 'BACKGROUND', '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. doi: 10.1016/j.invent.2016.06.003. Epub 2016 Jun 16.'}, {'pmid': '21749967', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'pmid': '30943983', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32149716', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30578218', 'type': 'BACKGROUND', '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.'}, {'pmid': '29499504', 'type': 'BACKGROUND', '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. 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Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.'}, {'pmid': '20685078', 'type': 'BACKGROUND', '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.'}, {'pmid': '18198807', 'type': 'BACKGROUND', '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.'}, {'pmid': '11556941', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16717171', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical insomnia (defined by scoring ≥ 15 on the insomnia severity index)\n\nExclusion Criteria:\n\n* under 18 y.o.\n* unable to read or write in English\n* do not own a Smart Phone'}, 'identificationModule': {'nctId': 'NCT05108194', 'briefTitle': 'Feasibility of a Personalized SMS Intervention for Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, St. Louis'}, 'officialTitle': 'Feasibility of a Personalized Short Message Service Intervention for Insomnia', 'orgStudyIdInfo': {'id': 'UMissouriSL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Intervention', 'description': "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.", 'interventionNames': ['Behavioral: SMS Personalized Sleep Intervention']}], 'interventions': [{'name': 'SMS Personalized Sleep Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Arm 1: Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63121', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Missouri-St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Chelsey R Wilks, PhD', 'role': 'CONTACT', 'email': 'chelseywilks@umsl.edu', 'phone': '(314) 516-5383'}], 'overallOfficials': [{'name': 'Chelsey R Wilks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri, St. Louis'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'One year after data collection is complete', 'ipdSharing': 'YES', 'description': 'De-identified participant outcome data will be made available to other researchers upon approval of home institution ethics approval.', 'accessCriteria': 'Approval from home institution internal review board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, St. Louis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chelsey Wilks', 'investigatorAffiliation': 'University of Missouri, St. Louis'}}}}