Feasibility of a Personalized SMS Intervention for Insomnia

April 18, 2022 updated by: Chelsey Wilks, University of Missouri, St. Louis

Feasibility of a Personalized Short Message Service Intervention for Insomnia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63121
        • Recruiting
        • University of Missouri-St Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index
Time Frame: 8 weeks
Insomnia severity
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 8 weeks
Usability of the intervention
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS: Sleep related impairment
Time Frame: 8 weeks
Sleep-related functional impairment
8 weeks
Flinders Fatigue Scale
Time Frame: 8 weeks
Fatigue
8 weeks
Patient Health questionnaire 8 item
Time Frame: 8 weeks
Depression
8 weeks
Difficulties in Emotion Regulation Scale
Time Frame: 8 weeks
Emotion regulation
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, St. Louis

Investigators

  • Principal Investigator: Chelsey R Wilks, PhD, University of Missouri, St. Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMissouriSL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant outcome data will be made available to other researchers upon approval of home institution ethics approval.

IPD Sharing Time Frame

One year after data collection is complete

IPD Sharing Access Criteria

Approval from home institution internal review board

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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