RECRUITING

Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Conditions

Chronic Insomnia Insomnia Cognitive Behavioral Therapy for Insomnia (CBTI)Digital Technology Adherence Monitoring

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Comparing Insomnia Care As Usual to Digital Augmentation

Quick Facts

Study Start:2023-08-16

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05490550

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Anne Germain, PhD

CONTACT

(412) 897-3183

anne@noctemhealth.com

Megan Wolfson, LCSW

CONTACT

(412) 360-4878

megan@noctemhealth.com

Principal Investigator

Anne Germain

PRINCIPAL_INVESTIGATOR

Noctem, LLC

Study Locations (Sites)

Madigan Army Medical Center

Lakewood, Washington, 98431

United States

Collaborators and Investigators

Sponsor: Noctem, LLC

Anne Germain, PRINCIPAL_INVESTIGATOR, Noctem, LLC

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 Registration Dates

Study Start Date2023-08-16

Study Completion Date2025-03

Study Record Updates

Study Start Date2023-08-16

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Insomnia
Cognitive Behavioral Therapy for Insomnia (CBTI)
Digital Technology
Adherence Monitoring

Additional Relevant MeSH Terms

Chronic Insomnia