Status:
COMPLETED
A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Insomnia
Depression
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive symptoms through disruption of brain networks that regulate emotional functions. However, we do not yet know to...
Eligibility Criteria
Inclusion
- Ages 25-60
- Subjective complaint of sleep disturbance for ≥ 3 months (ISI≥10)
- Subjective complaint of depression (BDI≥14) and not at imminent risk for suicide, as measured by CSSRS assessment
- Fluent and literate in English
- Written informed consent.
- Reside within 60 miles of Stanford University
Exclusion
- Presence of other sleep or circadian rhythm disorders
- Medications that would significantly impact sleep, alertness, or mood
- \>14 alcoholic drinks per week or \>4 drinks per occasion
- General medical condition, disease or neurological disorder that interferes with the assessments or outpatient participation
- Substance abuse or dependence
- Mild traumatic brain injury
- Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols
- Pregnant or breast feeding
- Current or lifetime history of bipolar disorder or psychosis
- Current or or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition
- Received CBT-I within the past year
- Acute or unstable chronic illness
- Current exposure to trauma, or exposure to trauma within the past 3 months
- Working a rotating shift that overlaps with 2400h.
- Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment" to the exclusion criteria
- Individuals who are not CPAP adherent or have untreated OSA of moderate severity or worse (AHI ≥ 15)
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04424407
Start Date
May 28 2021
End Date
March 23 2024
Last Update
October 15 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304