Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Cognitive Behavioral Therapy for Insomnia

Phase:

N/A

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

   - Caffeine consumption ≤ 3 8 ounce cups prior to lunch every day for ≥ 3 weeks prior to
   treatment

   - Written informed consent.

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 de novo cognitive behavior therapy 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.

Ages Eligible for Study

25 Years - 60 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrea N Goldstein-Piekarski
650-721-4780
Recruiting