Sleep Mechanisms Of Regulating Emotions Study for Insomnia and Depression

This study is looking at how a sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBT-I) affects the brain's ability to manage emotions in people with insomnia and depression. CBT-I uses techniques like changing sleep habits and thoughts about sleep to improve rest. Researchers want to see if improving sleep with CBT-I can change specific brain networks involved in emotion regulation, and if these changes help reduce symptoms of depression. You might be able to join if you are 18-65 years old, have had insomnia for at least 3 months, and also experience depressive symptoms. The study is currently unclear on its recruitment status and plans to enroll 120 participants.

Study design: This is an interventional study planning to enroll 120 participants. It is the second phase of a two-phased project.
What's involved: You would be assessed at the beginning of the study (week 1), throughout the treatment phase (weeks 3-11), at the end of treatment (week 13), and for a follow-up at 6 months (week 39). These assessments include functional magnetic resonance imaging (fMRI) brain scans and questionnaires like the Beck Depression Inventory.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed up for 6 months after the end of treatment (week 39).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Sleep Mechanisms Of Regulating Emotions

Recruiting

NAAges 18–65InterventionalTreatment

Stanford University

~120 participants

Updated 2026-04-20 on ClinicalTrials.gov

What's tested:Cognitive Behavioral Therapy for Insomnia

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over Assessed at baseline (week 1) and end of treatment (week 13)

+4 more outcomes measured

Conditions

Insomnia

Depression

Where it's being run

1 sites across 1 states

California1

Study leadership

Andrea Goldstein, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Kaela Mandler

[email protected]

650-721-6089

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imagingAssessed 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 imagingAssessed 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 InventoryAssessed 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 EfficiencyAssessed 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 ScoreAssessed 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.

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