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

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.

Inclusion Criteria:

To be included participants must > 21 years old and:

1. have a diagnosis of OSA with an AHI > 5 on a diagnostic polysomnogram;

2. accept PAP as primary/sole OSA therapy, been given a prescription for PAP and filled
it within the last 3 months, have had an opportunity to use PAP for at least one
month, and show mean use of > 1 hour per night;

3. have a complaint of persistent (i.e., > 3 months) sleep onset or sleep maintenance
difficulties despite having adequate opportunity for sleep and accompanied by
significant daytime impairment or distress about poor sleep;

4. an Insomnia Severity Index (ISI) score > 10 indicating at least "mild" insomnia; and

5. a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights per
week during two weeks of sleep diary monitoring.

Exclusion Criteria:

1. an untreated psychiatric disorder (e.g., major depression) found on structured
interviews as these conditions have specific treatments and it would be inappropriate
not to offer those treatments;

2. a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction for
insomnia may precipitate hallucinations and mania;

3. an imminent risk for suicide;

4. alcohol or drug abuse within the past year;

5. terminal illness (e.g., cancer), or neurological degenerative disease (e.g.,
dementia);

6. current use of medications known to cause insomnia (e.g., stimulants);

7. comorbid narcolepsy, idiopathic hypersomnia, restless legs syndrome (score of >11 in
the IRLS), periodic limb movement during sleep (known PLMS with arousal > 15 per
hour), or a circadian rhythm sleep disorder if habitual bedtimes are later than 3:00
AM or rising times are later than 11:00 AM; or

8. consuming > 2 alcoholic beverages per day on a regular basis; or

9. consuming more than 10 caffeinated beverages per day on a regular basis; or

10. consuming marijuana in any form on a regular basis >1 time per week, or if used after
4:00 p.m; or

11. change in thyroid medication dosage or received a new prescription for thyroid
medication 3 months before the screening visit; or

12. physician-diagnosed or self-reported seizure disorder.