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Behavioural Intervention

Adapted Cognitive-behavioral Therapy for Depression and Insomnia (CBTiA Trial)

N/A

Waitlist Available

Led By Rébecca Robillard

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current diagnosis of major depressive disorder or persistent depressive disorder confirmed by the Patient Health Questionnaire (PHQ-9) score > 10 and the MDE scale of the Mini International Neuropsychiatric Interview (M.I.N.I.)

Between 18 and 65 years old

Must not have

Taking stimulant medications including, but not limited to, Adderall, Concerta, Ritalin, Desoxyn, Dexedrine, Dextrostat, Ephedrine, Phentermine, Procentra, Vyvanse, and Selegline

Current diagnosis of bipolar disorder, psychotic disorder or post-traumatic stress disorder confirmed by the M.I.N.I.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from pre-intervention (week 0) to the last follow-up (week 10)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to tailor CBTi for people with depression and insomnia, using ambulatory monitoring to measure brain and heart activity throughout the intervention. Results could improve treatment satisfaction, effectiveness, and symptoms of insomnia and depression.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is a non-pharmacological trial focusing on cognitive-behavioral therapy delivered through digital means there are no direct side effects as typically associated with medications. However participants may experience discomfort wearing the ambulatory monitors or stress related to adherence to the intervention protocols.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major or persistent depression.

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I am between 18 and 65 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking stimulant medications.

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I have been diagnosed with bipolar, psychotic disorder, or PTSD.

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I have had a brain injury where I was unconscious for more than 5 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-intervention (week 0) to the last follow-up (week 10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-intervention (week 0) to the last follow-up (week 10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-intervention (week 0) to the last follow-up (week 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Satisfaction with treatment effectiveness as measured with the Modified Treatment Satisfaction Questionnaire for Medication

Treatment acceptability as measured by the Treatment Acceptability/Adherence Scale

Secondary study objectives

Changes in EEG power spectra

Changes in EEG-based sleep latency

Changes in EEG-based slow wave activity

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: eCBTi-objExperimental Treatment1 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-subjActive Control1 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.

0 / 6Eligibility criteria met