Feasibility of a Personalized SMS Intervention for Insomnia

NCT05108194 | Unknown Early Phase 1

• 1 other identifier: UMissouriSL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep Disorder

Keywords

Insomnia; Sleep

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  Insomnia severity

  8 weeks

Secondary Outcomes (1)

• System Usability Scale

  8 weeks

Other Outcomes (4)

• PROMIS: Sleep related impairment

  8 weeks

• Flinders Fatigue Scale

  8 weeks

• Patient Health questionnaire 8 item

  8 weeks

Study Arms (1)

Arm 1: Intervention

EXPERIMENTAL

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

Interventions

SMS Personalized Sleep Intervention BEHAVIORAL

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.

Arm 1: Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical insomnia (defined by scoring ≥ 15 on the insomnia severity index)

You may not qualify if:

• under 18 y.o.
• unable to read or write in English
• do not own a Smart Phone

Sponsors & Collaborators

• University of Missouri, St. Louis: lead

Study Sites (1)

University of Missouri-St Louis

St Louis, Missouri, 63121, United States

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chelsey R Wilks, PhD

  University of Missouri, St. Louis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsey R Wilks, PhD

CONTACT

(314) 516-5383; chelseywilks@umsl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will be enrolled in the intervention and all participants and study staff will be aware.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 4, 2021
• Study Start: November 15, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after data collection is complete
• Access Criteria: Approval from home institution internal review board

Locations

US (1)