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

NCT ID: NCT03109210

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Care

Participants randomized to standard care will receive normal follow-up care with their health care provider. This will include routine assessment and adjustment of PAP therapy, and instruction in proper sleep hygiene.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

In addition to standard care procedures, participants randomized to the intervention arm will receive up to two sequential treatments. First, participants will receive Online Cognitive Behavioral Therapy (OCBT). Those who meet criteria for remission after this first treatment will continue through follow-up without further treatment. Those who do not will be randomized again to either extended OCBT, or Therapist-directed Cognitive Behavioral Therapy (TCBT).

Group Type: EXPERIMENTAL

Online Cognitive Behavioral Therapy (OCBT)

Intervention Type: BEHAVIORAL

Cognitive behavioral therapy delivered via commercial online software.

Therapist-directed Cognitive Behavioral Therapy (TCBT)

Intervention Type: BEHAVIORAL

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

Interventions

Online Cognitive Behavioral Therapy (OCBT)

Cognitive behavioral therapy delivered via commercial online software.

Intervention Type: BEHAVIORAL

Therapist-directed Cognitive Behavioral Therapy (TCBT)

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

Intervention Type: BEHAVIORAL

Other Intervention Names

OCBT; TCBT

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford Univeristy

Palo Alto, California, United States

National Jewish Health

Denver, Colorado, United States

Countries

United States

References

Eldridge-Smith ED, Manber R, Tsai S, Kushida C, Simmons B, Johnson R, Horberg R, Depew A, Abraibesh A, Simpson N, Strand M, Espie CA, Edinger JD. Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol. Trials. 2022 Sep 24;23(1):806. doi: 10.1186/s13063-022-06753-4.

Reference Type: DERIVED

PMID: 36153634 (View on PubMed)

Other Identifiers

HS2989

Identifier Type: -

Identifier Source: org_study_id