Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Description

The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.

Conditions

Chronic Insomnia

Study Overview

Study Details

Study overview

The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.

Comparing Insomnia Care As Usual to Digital Augmentation

Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Condition
Chronic Insomnia
Intervention / Treatment

-

Contacts and Locations

Lakewood

Madigan Army Medical Center, Lakewood, Washington, United States, 98431

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician.
  • * Age 18 or older.
  • * Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures.
  • * If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks)
  • * Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)
  • * Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others.
  • * Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study.
  • * Having planned or attempted suicide or the harming of others in the past 6 months.
  • * Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care.
  • * Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living.
  • * Active substance use disorder.
  • * Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders.
  • * Currently pregnant, breastfeeding, or being the parent of a newborn \< 3 months old.
  • * Untreated seizure disorder.
  • * Suspected, diagnosed, or inadequately treated sleep apnea (less than 4 hours of CPAP use per night).
  • * Anticipates relocating/moving out of state in the next 3 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Noctem, LLC,

Anne Germain, PRINCIPAL_INVESTIGATOR, Noctem, LLC

Study Record Dates

2025-03