Status:
UNKNOWN
Using Sleep Wearables to Adapt Cognitive-behavioral Therapy for Insomnia in the Context of Depression (CBTiA)
Lead Sponsor:
University of Ottawa
Conditions:
Insomnia
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
1. Background Insomnia is a major public health burden that disproportionately affects individuals with depression. Sleep disturbances are present in approximately 80-90% of cases of depression an...
Eligibility Criteria
Inclusion
- Between 18 and 65 years old
- Asymptomatic on the Sleep Disorders Symptoms Checklist-25 (except for insomnia)
- Symptomatic on the Sleep Condition Indicator (i.e. score above \<3 on specific combination of items
- 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.)
- Having a smartphone and willingness to install a sleep intervention application on it
Exclusion
- Current diagnosis of bipolar disorder, psychotic disorder or post-traumatic stress disorder confirmed by the M.I.N.I.
- Brain injury with loss of consciousness for over 5 minutes
- Self-reported substance use disorder (i.e. alcohol, cannabis, or illicit drugs) or \> monthly use of illicit drugs reported on item-2 of the WHO Alcohol, Smoking and Substance Involvement Screening Test (except tobacco, alcohol, and cannabis)
- Body mass index \> 45
- Shift work or rotating shifts within 1 month of study entry
- Recent travel to a difference time zone
- Any clinically significant cardiopulmonary, gastrointestinal, pancreatic, hepatic, renal, hematologic, endocrine, neurological (including seizure disorder), or sleep disorder (other than insomnia)
- Taking any psychotropic medications p.r.n. (If taking any antidepressant or sleep medications, needs to be on a stable dose for at least 1 month prior to study start).
- Taking stimulant medications including, but not limited to, Adderall, Concerta, Ritalin, Desoxyn, Dexedrine, Dextrostat, Ephedrine, Phentermine, Procentra, Vyvanse, and Selegline
- Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires
- Individuals with mini-braids, dreadlocks, hair extension or natural afro-hair that can alter the EEG headband recording
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05990855
Start Date
August 1 2023
End Date
January 1 2025
Last Update
August 23 2023
Active Locations (1)
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1
Sleep Research Unit, University of Ottawa Institute of Mental Health Research at the Royal
Ottawa, Ontario, Canada, K1Z7K4