Feasibility of a Personalized SMS Intervention for Insomnia

Sponsor

University of Missouri, St. Louis (Other)

Overall Status

Recruiting

CT.gov ID

NCT05108194

Collaborator

(none)

Enrollment

Location

Arm

6.5

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Sleep Disorder	Behavioral: SMS Personalized Sleep Intervention	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Primary Purpose:

Treatment

Official Title:

Feasibility of a Personalized Short Message Service Intervention for Insomnia

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Insomnia Severity Index [8 weeks]
Insomnia severity

Secondary Outcome Measures

System Usability Scale [8 weeks]
Usability of the intervention

Other Outcome Measures

PROMIS: Sleep related impairment [8 weeks]
Sleep-related functional impairment
Flinders Fatigue Scale [8 weeks]
Fatigue
Patient Health questionnaire 8 item [8 weeks]
Depression
Difficulties in Emotion Regulation Scale [8 weeks]
Emotion regulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri-St Louis	Saint Louis	Missouri	United States	63121

Sponsors and Collaborators

University of Missouri, St. Louis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Chelsey Wilks, Assistant Professor, University of Missouri, St. Louis

ClinicalTrials.gov Identifier:

NCT05108194

Other Study ID Numbers:

UMissouriSL

First Posted:

Nov 4, 2021

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chelsey Wilks, Assistant Professor, University of Missouri, St. Louis

Insomnia

Sleep

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Sleep Wake Disorders

Study Results

No Results Posted as of Apr 25, 2022