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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CBTiA Trial 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.Check my eligibility

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.See study design

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.

CBTiA Trial 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.

CBTiA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Changes in EEG power spectra

Changes in EEG-based sleep latency

Changes in EEG-based slow wave activity

+23 more

CBTiA 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor

206 Previous Clinical Trials

266,089 Total Patients Enrolled

Rébecca RobillardPrincipal InvestigatorUniversity of Ottawa Institute of Mental Health Research at the Royal

Media Library

eCBTi-obj (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05990855 — N/A

Insomnia Research Study Groups: eCBTi-obj, eCBTi-subj

Insomnia Clinical Trial 2023: eCBTi-obj Highlights & Side Effects. Trial Name: NCT05990855 — N/A

eCBTi-obj (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05990855 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participants in this experimental research?

"This medical research is open to any individuals aged 18 and up, but not yet 65."

Answered by AI

Am I eligible to be a participant in this research study?

"52 individuals will be accepted into this insomnia study, so long as they are between legal adulthood and seniors."

Answered by AI

Are any enrollees being accepted into this experimental study at the present moment?

"According to records on clinicaltrials.gov, this medical investigation is no longer recruiting candidates. The study was initially posted on August 1st 2023 and underwent its most recent update around a week later. However, there are still 1563 other trials actively seeking participants at the moment of writing."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary assessment of this clinical trial, conducted over a 7 week period, will be the Treatment Component Adherence Scale to gauge treatment acceptability. Secondary metrics such as perceived symptom improvements and overall satisfaction with treatment effectiveness (as measured by the Modified Treatment Satisfaction Scale) will also be evaluated. This extended survey additionally looks at changes in insomnia symptoms (Insomnia Severity Index-7 scores), EEG-based sleep latency, energy level, work productivity, coping ability, life enjoyment levels, hopefulness indexing self-esteem and mood fluctuations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Sleep Wearables to Adapt Cognitive-behavioral Therapy for Insomnia in the Context of Depression (CBTiA)

Rébecca Robillard 2023. "Using Sleep Wearables to Adapt Cognitive-behavioral Therapy for Insomnia in the Context of Depression (CBTiA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05990855.