Clinical trial NCT04424407: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety
Official title: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Insomnia
Depression
Anxiety
CBT-I
Cognitive Behavioral Therapy for Insomnia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-06-11
Enrollment: 51
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-armed trial. All participants will receive Cognitive Behavioral Therapy for Insomnia
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging
timeFrame: Assessed at week 0 and week 11
measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
timeFrame: Assessed at week 0 and week 11
measure: Change in Beck Depression Inventory
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Sleep Efficiency
timeFrame: Assessed at week 0 and week 11
Secondary outcomes:
measure: Change in Columbia Suicide Severity Rating Scale
timeFrame: Assessed at week 0 and week 11
measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity
timeFrame: Assessed at week 0 and week 11
measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity
timeFrame: Assessed at week 0 and week 11
measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity
timeFrame: Assessed at week 0 and week 11
measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity
timeFrame: Assessed at week 0 and week 11
measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture
timeFrame: Assessed at week 0 and week 11
measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture
timeFrame: Assessed at week 0 and week 11
measure: Change in Sleep Physiology measured by PSG
timeFrame: Assessed at week 0 and week 11
measure: Change in Insomnia Severity Index (ISI) Scale Score
timeFrame: Assessed at week 0 and week 11
measure: Change in 36-Item Short Form Survey (SF-36) Score
timeFrame: Assessed at week 0 and week 11
measure: Change in Beck Anxiety Inventory
timeFrame: Assessed at week 0 and week 11
measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG
timeFrame: Assessed at week 0 and week 11
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrea Goldstein-Piekarski, PhD
role: PRINCIPAL_INVESTIGATOR
References: