Feasibility of a Personalized SMS Intervention for Insomnia

Insomnia Clinical Trial

Official title:

Feasibility of a Personalized Short Message Service Intervention for Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108194
• Other study ID #: UMissouriSL
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 15, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2022
• Source: University of Missouri, St. Louis
• Contact: Chelsey R Wilks, PhD
• Phone: (314) 516-5383
• Email: chelseywilks[@]umsl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Missouri-St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, St. Louis

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS: Sleep related impairment	Sleep-related functional impairment	8 weeks
Other	Flinders Fatigue Scale	Fatigue	8 weeks
Other	Patient Health questionnaire 8 item	Depression	8 weeks
Other	Difficulties in Emotion Regulation Scale	Emotion regulation	8 weeks
Primary	Insomnia Severity Index	Insomnia severity	8 weeks
Secondary	System Usability Scale	Usability of the intervention	8 weeks