RecruitingNot ApplicableNCT06373718

Sleep Mechanisms Of Regulating Emotions

A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)


Sponsor

Stanford University

Enrollment

150 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.


Eligibility

Min Age: 25 YearsMax Age: 60 Years

Inclusion Criteria7

  • Males and females of any racial or ethnic group, aged 25-60
  • Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10)
  • Insomnia complaint ≥ 3 months in duration
  • Subjective complaint of depressive symptoms as defined by scores of ≥ 14 on the BDI
  • Fluent and literate in English
  • Written, informed consent
  • Reside within 60 miles of Stanford University

Exclusion Criteria16

  • Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders
  • Use of psychotropic medications that would significantly impact sleep, alertness, or mood and unwilling or unable to discontinue medication specifically prescribed for sleep disturbance \> two weeks (anti-depressants) or \>1 week (sleep medications) prior to baseline data collection
  • Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion)
  • Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment
  • General medical condition, disease or neurological disorder that interferes with the assessments
  • Substance abuse or dependence
  • History of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
  • Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
  • Pregnant or breast feeding
  • Current or lifetime history of bipolar disorder or psychosis
  • Current or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition
  • Received cognitive behavioral therapy for insomnia within the past year
  • Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months
  • Current exposure to trauma, or exposure to trauma within the past 3 months
  • Working a rotating shift that overlaps with 2400h
  • Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent or have untreated OSA of moderate severity or worse (AHI ≥ 15)

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia

CBT-I improves sleep through a combination of behavioral interventions (stimulus control (SC), sleep restriction (SR)), cognitive therapy (CT) as well as additional components such as mindfulness training and sleep hygiene education. SC is an intervention that re-establishes the connection between the bed/bedroom with sleep to help develop a more consistent sleep/wake pattern. SR leads to higher quality sleep by reducing excessive time spent in bed to the actual amount of sleep, thereby creating mild sleep deprivation and increasing the homeostatic sleep drive. Like CT for other disorders, CT for insomnia targets maladaptive thoughts and cognitions that may interfere with sleep.


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06373718


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