NCT03109210

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Insomnia, Primary
• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-15
• Primary completion: 2022-04-14
• Completion: 2026-06-30
• First posted: 2017-04-12
• Last updated: 2025-02-21

Locations

2 sites across 1 country: United States