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

Not Recruiting

Trial ID: NCT04424407

Purpose

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 what degree the emotion regulation brain network is modified by the restoration of sleep, or whether the degree to which a sleep intervention modifies these neural targets mediates reductions in other depressive symptoms including suicidality. The overall aim is to test the efficacy of an established sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in reducing depressive symptoms through improving emotion regulation brain function in individuals with elevated depressive symptoms and clinically meaningful sleep disturbance. In this study, we will assess feasibility of recruitment and retention as well as target engagement. Target engagement is defined as the treatment effect on increasing mPFC-amygala connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation paradigms. Participants will be 70 adults experiencing at least moderate sleep disturbances and who also have elevated anxious and/or depressive symptoms. Emotion distress and sleep disruption will be assessed prior to, and weekly while receiving six Cognitive Behavioral Therapy for Insomnia (CBT-I) across a period of 8 weeks. CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Using fMRI scanning, emotion regulation network neural targets will be assayed prior to and following completion of CBT-I treatment.

Official Title

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

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Ages 25-60

   - Subjective complaint of sleep disturbance for ≥ 3 months (ISI>15)

   - 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 Criteria:

   - 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)

Intervention(s):

behavioral: Cognitive Behavioral Therapy for Insomnia

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pandora Lam
650-497-5130