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Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

NCT05490550 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-03-21

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

COAST-enhanced CBTI

Participants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed.

BEHAVIORAL

Military Treatment Facility Insomnia Care As Usual

Participants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place.

Sponsors & Collaborators

  • Noctem, LLC

    lead INDUSTRY

Principal Investigators

  • Anne Germain · Noctem, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490550 on ClinicalTrials.gov