NCT06373718 · Stanford University
Sleep Mechanisms Of Regulating Emotions
(SleepMORE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Cognitive Behavioral Therapy for Insomnia
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.
Primary outcome measures
Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging
Time frame: Assessed at baseline (week 1) and end of treatment (week 13)
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.
Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
Time frame: Assessed at baseline (week 1) and end of treatment (week 13)
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.
Change in Beck Depression Inventory
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)
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.
Change in PSG Sleep Efficiency
Time frame: Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)
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.
Change in Insomnia Severity Index (ISI) Scale Score
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)
Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females of any racial or ethnic group, aged 18-65
- 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)
Where
- Palo Alto, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations