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

• ClinicalTrials.gov Identifier: NCT03109210
• Recruitment Status: Recruiting
• First Posted: April 12, 2017
• Last Update Posted: September 9, 2020
• Sponsor: National Jewish Health
• Collaborator: Stanford University
• Information provided by (Responsible Party): National Jewish Health

Tracking Information

• First Submitted Date: March 27, 2017
• First Posted Date: April 12, 2017
• Last Update Posted Date: September 9, 2020
• Actual Study Start Date: April 15, 2017
• Estimated Primary Completion Date: April 14, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2017)

• Insomnia Severity Index (ISI) score change [ Time Frame: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment. ]
  Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
• Quebec Sleep Questionnaire (QSQ) score change [ Time Frame: Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28. ]
  Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 5, 2017)

• Change in subjective measurement of total sleep time [ Time Frame: Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time. ]
  Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of total sleep time.
• Change in subjective measurement of sleep efficiency [ Time Frame: Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time. ]
  Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of sleep efficiency.
• Positive Airway Pressure (PAP) Therapy Adherence [ Time Frame: Adherence data will be collected through study completion, an average of one year. ]
  Participants' adherence to PAP therapy will be passively monitored during their participation in the study.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea
• Official Title: Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Insomnia, Primary
• Sleep Apnea, Obstructive

Intervention

• Behavioral: Online Cognitive Behavioral Therapy (OCBT)
  Cognitive behavioral therapy delivered via commercial online software.
  Other Name: OCBT
• Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)
  Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.
  Other Name: TCBT

Study Arms

• No Intervention: 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.
• Experimental: 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).
  Interventions:

  • Behavioral: Online Cognitive Behavioral Therapy (OCBT)
  • Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 5, 2017): 384
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 14, 2023
• Estimated Primary Completion Date: April 14, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Rachel Johnson, MA; 303-398-1058; johnsonr@njhealth.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03109210
• Other Study ID Numbers: HS2989
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: National Jewish Health
• Study Sponsor: National Jewish Health
• Collaborators: Stanford University
• Investigators: Not Provided
• PRS Account: National Jewish Health
• Verification Date: September 2020