N/A Completed N=51 Treatment

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

Source: ClinicalTrials.gov NCT04424407 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcomePrimary: Change in Amygdala Activation During the Facial Expressions of Emotion Task (Conscious Condition) as Assessed by Functional Magnetic Resonance Imaging — 0.11; -0.18; 0.22; -0.25 Beta weights (arbitrary units) — p=0.008

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 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-amygdala 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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Amygdala Activation During the Facial Expressions of Emotion Task (Conscious Condition) as Assessed by Functional Magnetic Resonance Imaging	0.11; -0.18; 0.22; -0.25; 0.11; -0.07	0.008 sig
PRIMARY Change in Amygdala Activation During the Facial Expressions of Emotion Task (Nonconscious Condition) as Assessed by Functional Magnetic Resonance Imaging	-0.01; -0.01; 0.009; -0.01; 0.02; 0.001	0.99
PRIMARY Change in Amygdala Activation During the Emotion Regulation Scenes Task	0.35; 0.05; -0.05; 0.03	0.65
PRIMARY Change in Amygdala-Medial Prefrontal Cortex Connectivity During the Facial Expressions of Emotion Task (Conscious Condition) as Assessed by Functional Magnetic Resonance Imaging	0.004; 0.02; -0.04; -0.02; 0.007; -0.10	0.86
PRIMARY Change in Beck Depression Inventory (BDI)	17.5; -6.61	<0.0001 sig
PRIMARY Change in PSG Sleep Efficiency	78.9; 8.57	0.002 sig
SECONDARY Change in Beck Scale of Suicidal Ideation Total Score	1.74; -1.11	<0.0001 sig
SECONDARY Change in Columbia Suicide Severity Rating Scale	37; 41; 13; 5; 0; 1	0.03 sig
SECONDARY Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity	—	—
SECONDARY Change in Actigraph Number of Arousals as a Measure of Sleep Continuity	—	—
SECONDARY Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity	—	—
SECONDARY Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity	—	—
SECONDARY Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity	—	—
SECONDARY Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture	30.29; -11.44	0.28
SECONDARY Change in PSG Number of Arousals as a Measure of Sleep Architecture	21.96; -1.44	0.33
SECONDARY Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture	58.3; -27.74	0.013 sig
SECONDARY Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture	362.23; 5.67	0.66
SECONDARY Change in Sleep Physiology Measured by PSG	29.52; 0.04; 18.77; 0.40; 17.47; 0.37	0.96
SECONDARY Change in Insomnia Severity Index (ISI) Scale Score	15.7; -7.98	<0.0001 sig
SECONDARY Change in 36-Item Short Form Survey (SF-36) Score	31.72; 7.64; 54.38; 0.25	<0.0001 sig
SECONDARY Change in Beck Anxiety Inventory (BAI)	9.87; -3.78	<0.0001 sig
SECONDARY Change in Respiratory Sinus Arrhythmia (RSA)- Measured by PSG	—	—

Eligibility Criteria

Inclusion Criteria

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 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)

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Data sourced from ClinicalTrials.gov (NCT04424407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.