Feasibility of a Personalized SMS Intervention for Insomnia

Early Phase 1

• Conditions: Insomnia; Sleep Disorder
• Interventions: Behavioral: SMS Personalized Sleep Intervention

• Registration Number: NCT05108194
• Lead Sponsor: University of Missouri, St. Louis

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.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-04
• Study Start: 2021-11-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: Intervention	SMS Personalized Sleep 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.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	8 weeks	Insomnia severity

Secondary Outcome Measures

Name	Time	Method
System Usability Scale	8 weeks	Usability of the intervention

Trial Locations

Locations (1)

University of Missouri-St Louis; 🇺🇸 Saint Louis, Missouri, United States