Clinical trial NCT05108194: Feasibility of a Personalized SMS Intervention for Insomnia
Official title: Feasibility of a Personalized Short Message Service Intervention for Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Insomnia
Sleep Disorder
Keywords: Insomnia
Sleep
Lead sponsor: University of Missouri, St. Louis
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will enroll in the intervention after a two week assessment phase.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 8 weeks
Secondary outcomes:
measure: System Usability Scale
timeFrame: 8 weeks
Other outcomes:
measure: PROMIS: Sleep related impairment
timeFrame: 8 weeks
measure: Flinders Fatigue Scale
timeFrame: 8 weeks
measure: Patient Health questionnaire 8 item
timeFrame: 8 weeks
measure: Difficulties in Emotion Regulation Scale
timeFrame: 8 weeks
Locations:
city: Saint Louis
country: United States
facility: University of Missouri-St Louis
state: Missouri
Study officials:
affiliation: University of Missouri, St. Louis
name: Chelsey R Wilks, PhD
role: PRINCIPAL_INVESTIGATOR
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