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

NCT05990855 | Unknown

• 1 other identifier: 2022030
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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

Insomnia; Major Depressive Disorder; Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (2)

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

  Satisfaction with treatment effectiveness, side effects, and convenience as rated on the Modified Treatment Satisfaction Questionnaire for Medication (mTQSM). The TQSM is a 14-item self-report scale with total scores ranging from 14-98, higher scores indicating greater treatment satisfaction. This questionnaire has been adapted for the purpose of this study: the term "medication" has been replaced by "intervention", and the term "condition" had been replaced by "symptoms of insomnia or depression".

  7 weeks

• Treatment acceptability as measured by the Treatment Acceptability/Adherence Scale

  Adherence to CBT-I guidelines and perceived helpfulness of treatment guidelines as rated on the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item questionnaire with total scores ranging from 10-70, higher scores indicating greater treatment acceptability and adherence.

  7 weeks

Secondary Outcomes (26)

• Treatment acceptability as indexed by the number of drop outs

  7 weeks

• Satisfaction with treatment effectiveness as measured by the Modified Treatment Satisfaction Scale

  7 weeks

• Changes in insomnia symptoms

  From pre-intervention (week 0) to the last follow-up (week 10)

• Changes in EEG-based sleep latency

  From pre-intervention (week 0) to post-intervention (week 7)

• Changes in EEG-based total sleep time

  From pre-intervention (week 0) to post-intervention (week 7)

Study Arms (2)

eCBTi-obj

EXPERIMENTAL

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.

Combination Product: eCBTi-obj

eCBTi-subj

ACTIVE COMPARATOR

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.

Behavioral: eCBTi-subj

Interventions

eCBTi-obj COMBINATION_PRODUCT

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

eCBTi-obj

eCBTi-subj BEHAVIORAL

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

eCBTi-subj

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

Sleep Research Unit, University of Ottawa Institute of Mental Health Research at the Royal

Ottawa, Ontario, K1Z7K4, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Rébecca Robillard

  University of Ottawa Institute of Mental Health Research at The Royal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rébecca Robillard, PhD

CONTACT

(613) 722-6521; CBTiA@theroyal.ca

Caitlin Higginson, MSc

CONTACT

(613) 722-6521; Caitlin.Higginson@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All researchers involved in clinical assessments or data processing will be blinded to the assignment of these different conditions. Participants will be asked not to discuss the modality of sleep measurements (Sleep diary or EEG headband) with the research staff or their care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)