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Feasibility of a Personalized SMS Intervention for Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05108194
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Chelsey Wilks, University of Missouri, St. Louis

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Sleep Disorder Behavioral: SMS Personalized Sleep Intervention Early Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will enroll in the intervention after a two week assessment phase.
Masking: None (Open Label)
Masking Description: All participants will be enrolled in the intervention and all participants and study staff will be aware.
Primary Purpose: Treatment
Official Title: Feasibility of a Personalized Short Message Service Intervention for Insomnia
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: 8 weeks ]
    Insomnia severity


Secondary Outcome Measures :
  1. System Usability Scale [ Time Frame: 8 weeks ]
    Usability of the intervention


Other Outcome Measures:
  1. PROMIS: Sleep related impairment [ Time Frame: 8 weeks ]
    Sleep-related functional impairment

  2. Flinders Fatigue Scale [ Time Frame: 8 weeks ]
    Fatigue

  3. Patient Health questionnaire 8 item [ Time Frame: 8 weeks ]
    Depression

  4. Difficulties in Emotion Regulation Scale [ Time Frame: 8 weeks ]
    Emotion regulation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108194


Contacts
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Contact: Chelsey R Wilks, PhD (314) 516-5383 chelseywilks@umsl.edu

Locations
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United States, Missouri
University of Missouri-St Louis Recruiting
Saint Louis, Missouri, United States, 63121
Sponsors and Collaborators
University of Missouri, St. Louis
Investigators
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Principal Investigator: Chelsey R Wilks, PhD University of Missouri, St. Louis
More Information
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Publications:
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
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

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Responsible Party: Chelsey Wilks, Assistant Professor, University of Missouri, St. Louis
ClinicalTrials.gov Identifier: NCT05108194    
Other Study ID Numbers: UMissouriSL
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant outcome data will be made available to other researchers upon approval of home institution ethics approval.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year after data collection is complete
Access Criteria: Approval from home institution internal review board

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chelsey Wilks, University of Missouri, St. Louis:
Insomnia
Sleep
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Nervous System Diseases
Mental Disorders
Neurologic Manifestations