Sleep Mechanisms Of Regulating Emotions

Stanford University150 enrolled

Overview

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.

Several lines of evidence suggest that insomnia contributes to emotionally distressing depressive mood symptoms through disruption of brain networks that regulate emotional functions. Of particular concern, insomnia is associated with an increased risk for suicide, even when accounting for the presence of other depressive symptoms. However, it is not yet know to what degree that the emotion regulation brain network is modified by the restoration of sleep, or whether the degree to which a sleep intervention engages these neural targets mediates reductions in depressive symptoms and suicidality. This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target. This project aims to extend the initial findings from the first phase (IRB-56961) to (1) confirm target engagement, defined as the treatment effect on increasing mPFC-amygdala connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation paradigms, by testing the hypothesis that compared with a control condition, CBT-I participants will show significant change in the emotion regulation network targets that met the Go Criteria of the first phase in the direction of normalization, at the end of treatment, (2) examine the relationships of target engagement to treatment outcomes by study group, and (3) test whether emotion regulation network measures at baseline predict depressive symptom and suicidality reduction. Participants will be 150 adults experiencing at least moderate sleep disturbances and who also have elevated anxious and/or depressive symptoms. Eligible participants will be randomized into either the Immediate Treatment group, which will receive six sessions of CBT-I over the eight weeks of treatment phase immediately after randomization, or the Enhanced Sleep Hygiene group, which will be provided with two sessions of sleep hygiene / sleep education and four additional meetings including monitoring of sleep and mood symptoms and will be offered the same CBT-I as the Immediate Treatment group upon completion of the 6-month follow-up session, approximately 7 months after randomization. Emotion distress and sleep disruption will be assessed prior to, and weekly during the eight weeks of treatment phase. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Insomnia Depression

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

CBT-I improves sleep through a combination of behavioral interventions (stimulus control (SC), sleep restriction (SR)), cognitive therapy (CT) as well as additional components such as mindfulness training and sleep hygiene education. SC is an intervention that re-establishes the connection between the bed/bedroom with sleep to help develop a more consistent sleep/wake pattern. SR leads to higher quality sleep by reducing excessive time spent in bed to the actual amount of sleep, thereby creating mild sleep deprivation and increasing the homeostatic sleep drive. Like CT for other disorders, CT for insomnia targets maladaptive thoughts and cognitions that may interfere with sleep.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females of any racial or ethnic group, aged 25-60 * Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10) * Insomnia complaint ≥ 3 months in duration * Subjective complaint of depressive symptoms as defined by scores of ≥ 14 on the BDI * 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 that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders * Use of psychotropic medications that would significantly impact sleep, alertness, or mood and unwilling or unable to discontinue medication specifically prescribed for sleep disturbance \> two weeks (anti-depressants) or \>1 week (sleep medications) prior to baseline data collection * Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion) * Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment * General medical condition, disease or neurological disorder that interferes with the assessments * Substance abuse or dependence * History of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities OR traumatic brain injury in the past two months * Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols * Pregnant or breast feeding * Current or lifetime history of bipolar disorder or psychosis * Current or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition * Received cognitive behavioral therapy for insomnia within the past year * Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months * Current exposure to trauma, or exposure to trauma within the past 3 months * Working a rotating shift that overlaps with 2400h * Individuals who were high risk for sleep apnea on the Berlin Questionnaire and are not CPAP adherent or have untreated OSA of moderate severity or worse (AHI ≥ 15)

Locations (1)

Stanford University

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging

During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit activation will be quantified by blood flow in regions of interest.

Time frame: Assessed at baseline (week 1) and end of treatment (week 13)

Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging

During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit connectivity will be quantified by the correlation of the blood flow between regions of interest.

Time frame: Assessed at baseline (week 1) and end of treatment (week 13)

Change in Beck Depression Inventory

This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe). The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.

Time frame: Assessed at baseline (week 1), throughout treatment phase (weeks 3-11), end of treatment (week 13), and 6-month follow-up (week 39)

Change in PSG Sleep Efficiency

Sleep efficiency (SE) is the percentage of total time in bed actually spent sleeping. Based on the overnight PSG sleep recording, SE will be calculated as the total time (minutes) spent asleep (sum of Stages N1, N2, N3, and REM) divided by the total time (minutes) in bed, and multiplied by 100.

Central Contacts

Pandora A Lam

CONTACT

650-497-5130 pal217@stanford.edu

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in Columbia Suicide Severity Rating Scale

The Columbia Suicide Severity Rating Scale is a 12-item checklist that was designed to quantify the severity of suicidal ideation and behavior. It is composed of two parts. The first six questions ask about suicidal ideation and behavior in the past month while the last six questions ask about suicidal ideation and behavior since the last visit. The CSSRS has been proven to be reliable and valid. It has also been shown to have high sensitivity and specificity to the different suicidal behavior classifications.