Adapted Cognitive-behavioral Therapy for Depression and Insomnia

(CBTiA Trial)

Overseen By Caitlin Higginson, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Ottawa

Must not be taking: Stimulants, Psychotropics

Disqualifiers: Bipolar, Psychotic, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to better adapt cognitive behavioral therapy for insomnia (CBTi) for people with comorbid depression by using objective sleep measures to tailor the behavioral interventions components of CBTi. Using ambulatory monitors, we also aim to investigate changes in brain activity and heart rate throughout the intervention. In this parallel-group randomized clinical trial, participants undergo one week of baseline ambulatory monitoring after which they are randomly assigned to one of two intervention arms: 1) digitally delivered CBTi (eCBTi) based on standard subjective sleep measures (sleep diary), or 2) eCBTi based on objective sleep measures (EEG headband). The intervention spans over 5-weeks, followed by a week of ambulatory monitoring and follow-up measures one week and one month after the end of the intervention. The study also includes a post-intervention interview to gather feedback on participant experiences. The overall protocol includes online questionnaires and structured clinical interviews assessing sleep, insomnia, and mental health, as well as treatment-related measures before, during, and after the intervention. It is anticipated that eCBTi using objective sleep measures will lead to better treatment acceptability, satisfaction, and effectiveness, including greater improvements in symptoms of insomnia and depression. It is also anticipated that sleep EEG and heart rate profiles will improve along the course of eCBTi.

Who Is on the Research Team?

Rébecca Robillard

Principal Investigator

University of Ottawa Institute of Mental Health Research at The Royal

Are You a Good Fit for This Trial?

Adults aged 18-65 with major depressive disorder or persistent depressive disorder, confirmed by specific questionnaire scores, who experience insomnia. Participants must have a smartphone for the sleep intervention app and speak English well enough to consent and follow study instructions. Exclusions include recent time zone travel, certain hairstyles affecting EEG recordings, bipolar/psychotic disorders, brain injury with significant unconsciousness, substance abuse (except tobacco/alcohol), extreme obesity (BMI >45), shift work within a month of entry, other significant health issues or unstable medication use.

Inclusion Criteria

I have been diagnosed with major or persistent depression.

You have sleep problems that are causing noticeable symptoms.

I don't have sleep problems except for trouble falling or staying asleep.

Exclusion Criteria

I am currently taking stimulant medications.

Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires

You have certain hairstyles like mini-braids, dreadlocks, hair extensions, or natural afro-hair that might affect the recording of the EEG headband.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening form and phone interview

Baseline Monitoring

Participants undergo 7 days of home-based ambulatory monitoring using EEG headband and other devices

1 week

1 visit (in-person) to collect and return equipment

Treatment

Participants receive a 5-week eCBTi program delivered via a mobile application, with weekly adjustments to sleep window based on sleep data

5 weeks

Weekly virtual feedback sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment questionnaires and psychiatric assessments

4 weeks

1 in-person visit and additional virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• eCBTi-obj
• eCBTi-subj

Trial Overview The trial is testing two forms of digitally delivered cognitive behavioral therapy for insomnia tailored to people with depression: one based on subjective sleep diaries (eCBTi-subj) and another using objective measures from an EEG headband (eCBTi-obj). The study includes initial monitoring, a 5-week treatment phase with either method randomly assigned, followed by post-treatment monitoring and interviews to assess satisfaction and effectiveness in improving sleep and depression symptoms.

How Is the Trial Designed?

Group I: eCBTi-obj Experimental Treatment 1 Intervention

In the experimental condition, participants will complete a 5-week eCBTi program delivered via a mobile application while wearing an EEG headband (Muse S) during sleep. As part of the sleep restriction therapy component of CBTi, participants will be asked to follow an individualized sleep window (i.e., bed and wake schedule) which will be adjusted each week based on objective sleep data derived from their EEG recordings from the previous week. Participants will also receive a weekly sleep report based on this data.

Group II: eCBTi-subj Active Control 1 Intervention

In the active comparator condition, participants will complete the same 5-week eCBTi program, but will not be wearing an EEG headband during the intervention. As part of the sleep restriction therapy component of CBTi, participants will be asked to follow an individualized sleep window (i.e., bed and wake schedule) which will be adjusted each week based on the subjective sleep data derived from their sleep diary of the previous week, as is typically done during classical CBTi. Participants will not receive any EEG-based sleep report during the intervention.

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+