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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This dual-site randomized clinical trial will use a "SMART" design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with online Cognitive Behavioral Therapy improves short-term outcomes of comorbid obstructive sleep apnea(OSA)/insomnia; and (2) providing a higher intensity 2nd-stage cognitive behavioral therapy (CBT) to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. After completing baseline assessment, the 384 comorbid OSA\insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT (n=288) or UC (usual care PAP + sleep hygiene education; n=96). Insomnia and OSA will be reassessed after 8 weeks. OCBT recipients who meet "remission" criteria will continue PAP but be offered no additional insomnia intervention and will complete study outcome measures again after an additional 8-weeks and at 3 and 6 month follow-ups. OCBT recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, expanded engagement in OCBT or a switch to therapist-directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points. ;

Study Design

Related Conditions & MeSH terms

Apnea
Insomnia, Primary
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT03109210
Study type	Interventional
Source	National Jewish Health
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 15, 2017
Completion date	June 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms