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Feasibility of a Personalized SMS Intervention for Insomnia

Primary Purpose

Insomnia, Sleep Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
SMS Personalized Sleep Intervention
Sponsored by
University of Missouri, St. Louis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri-St LouisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
Insomnia severity

Secondary Outcome Measures

System Usability Scale
Usability of the intervention

Full Information

First Posted
October 11, 2021
Last Updated
April 18, 2022
Sponsor
University of Missouri, St. Louis
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1. Study Identification

Unique Protocol Identification Number
NCT05108194
Brief Title
Feasibility of a Personalized SMS Intervention for Insomnia
Official Title
Feasibility of a Personalized Short Message Service Intervention for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, St. Louis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Disorder
Keywords
Insomnia, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All participants will enroll in the intervention after a two week assessment phase.
Masking
None (Open Label)
Masking Description
All participants will be enrolled in the intervention and all participants and study staff will be aware.
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS Personalized Sleep Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Insomnia severity
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
System Usability Scale
Description
Usability of the intervention
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
PROMIS: Sleep related impairment
Description
Sleep-related functional impairment
Time Frame
8 weeks
Title
Flinders Fatigue Scale
Description
Fatigue
Time Frame
8 weeks
Title
Patient Health questionnaire 8 item
Description
Depression
Time Frame
8 weeks
Title
Difficulties in Emotion Regulation Scale
Description
Emotion regulation
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsey R Wilks, PhD
Phone
(314) 516-5383
Email
chelseywilks@umsl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chelsey R Wilks, PhD
Organizational Affiliation
University of Missouri, St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Feasibility of a Personalized SMS Intervention for Insomnia

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