©2024 Stanford Medicine
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-amydgala
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