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

NCT05990855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-08-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

COMBINATION_PRODUCT

eCBTi-obj

eCBTi based on objective sleep measures recorded by the Muse S headband.

BEHAVIORAL

eCBTi-subj

eCBTi based on standard subjective sleep measures recorded on the sleep diary.

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Rébecca Robillard · University of Ottawa Institute of Mental Health Research at The Royal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990855 on ClinicalTrials.gov