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Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea

NCT03109210 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-02-21

No results posted yet for this study

Summary

This two-site randomized clinical trial will investigate and compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.

Conditions

  • Insomnia, Primary
  • Sleep Apnea, Obstructive

Interventions

BEHAVIORAL

Online Cognitive Behavioral Therapy (OCBT)

Cognitive behavioral therapy delivered via commercial online software.

BEHAVIORAL

Therapist-directed Cognitive Behavioral Therapy (TCBT)

Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2022-04-14
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03109210 on ClinicalTrials.gov