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Feasibility of a Personalized SMS Intervention for Insomnia

Feasibility of a Personalized Short Message Service Intervention for Insomnia

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05108194
Enrollment
50
Registered
2021-11-04
Start date
2021-11-15
Completion date
2022-06-01
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Sleep Disorder

Keywords

Insomnia, Sleep

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.

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.

Interventions

BEHAVIORALSMS 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.

Sponsors

University of Missouri, St. Louis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

All participants will be enrolled in the intervention and all participants and study staff will be aware.

Intervention model description

All participants will enroll in the intervention after a two week assessment phase.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity Index8 weeksInsomnia severity

Secondary

MeasureTime frameDescription
System Usability Scale8 weeksUsability of the intervention

Other

MeasureTime frameDescription
PROMIS: Sleep related impairment8 weeksSleep-related functional impairment
Flinders Fatigue Scale8 weeksFatigue
Patient Health questionnaire 8 item8 weeksDepression
Difficulties in Emotion Regulation Scale8 weeksEmotion regulation

Countries

United States

Contacts

Primary ContactChelsey R Wilks, PhD
chelseywilks@umsl.edu(314) 516-5383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026