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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help individuals with both depression and insomnia. It employs a digital version of cognitive-behavioral therapy for insomnia (CBTi) and compares two methods: one uses an EEG headband to track sleep patterns, while the other relies on a sleep diary. The researchers aim to determine if the headband approach improves treatment satisfaction and effectiveness. Ideal participants have a current diagnosis of depression, experience insomnia, and are open to using a smartphone app for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for depression and insomnia.

Will I have to stop taking my current medications?

If you are taking antidepressant or sleep medications, you need to be on a stable dose for at least 1 month before starting the study. If you are taking stimulant medications, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that electronic Cognitive Behavioral Therapy for Insomnia (eCBTi) is generally safe for most people. Studies have found that eCBTi is as effective as in-person therapy for treating insomnia, indicating its safety. Specifically, online CBTI carries a low risk of serious side effects, which are rare.

For the eCBTi-obj treatment, which uses a headband to monitor sleep, studies have not identified any major safety issues. This headband is a non-invasive device commonly used in sleep studies without causing harm.

The eCBTi-subj treatment, which involves sleep diaries, also has a similar safety record. Research consistently shows that online CBTI is well-tolerated, with few side effects.

Both treatments aim to improve sleep and mood with low risk, making them promising options for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to tackle depression and insomnia using an enhanced version of cognitive-behavioral therapy (CBT). Traditional CBT for insomnia usually relies on subjective sleep diaries to tailor sleep schedules. However, one approach in this trial, called eCBTi-obj, goes further by incorporating EEG headbands to track sleep patterns objectively, providing real-time data to fine-tune sleep strategies. This could lead to more precise and personalized treatment plans. The other arm, eCBTi-subj, sticks to the conventional method but still offers a structured program via a mobile app, making therapy more accessible and convenient. Researchers hope these innovations will offer more effective and user-friendly options for managing these conditions.

What evidence suggests that this trial's treatments could be effective for depression and insomnia?

Research has shown that online cognitive-behavioral therapy for insomnia (eCBTi) effectively reduces insomnia severity. Studies indicate that eCBTi can be as effective as face-to-face therapy, improving sleep quality and efficiency. In this trial, participants will join one of two treatment arms. Those using a special sleep-tracking headband (eCBTi-obj) will receive personalized digital CBTi, which has proven effective in treating long-term insomnia. One study found that digital CBTi significantly reduced insomnia symptoms, with 18.6% of participants experiencing complete relief. Participants in the eCBTi-subj arm, based on personal sleep reports, will also receive effective treatment, improving insomnia severity and other sleep-related issues. Both treatment methods show promise for people with insomnia, especially when linked with depression. ^{3 4 5 6 7}

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

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

I am currently taking stimulant medications.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9978641/

The Implementation and Effectiveness of Digital Cognitive ... Among enrollees, digital CBTi was acceptable and the Insomnia Severity Index decreased by 4.3 points (t = 6.41, p < 0.001) and 13 (18.6%) reached remission. The ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia This review summarizes evidence on CBT-I/eCBT-I and AI, highlighting key gaps. •. eCBT-I provides similar effectiveness to in-clinic CBT-I ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0285757

Protocol for a randomized controlled trial | PLOS One While e-CBTi produces comparable outcomes to in-person CBTi, there is a lack of comparison to active pharmacotherapies.

4. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... The findings of this study offer compelling evidence for the efficacy of tailored, digital CBT-I to treat chronic insomnia among older adults.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05990855

Using Sleep Wearables to Adapt Cognitive-behavioral ... This study aims to better adapt cognitive behavioral therapy for insomnia (CBTi) for people with comorbid depression by using objective sleep measures to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11384180/

Efficacy of eHealth Versus In-Person Cognitive Behavioral ... eCBTI and ipCBTI were found to be statistically significantly equivalent for treating insomnia for most examined outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2279754/

Cognitive Behavioral Therapy for Insomnia Enhances ... Indication of Efficacy​​ EsCIT + CBTI resulted in a higher rate of remission from depression (61.5%) than EsCIT + CTRL (33.3%), but this large difference was not ...