Sleep Mechanisms Of Regulating Emotions

NCT06373718 | Recruiting DMC

• 2 other identifiers: IRB-74553R33MH120245
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Depression

Keywords

Insomnia; Depression; Anxiety; CBT-I; Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

• Change in Insomnia Severity Index (ISI) Scale Score

  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.

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

Secondary Outcomes (15)

• Change in Columbia Suicide Severity Rating Scale

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

• Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

• Change in Actigraph Number of Arousals as a Measure of Sleep Continuity

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

• Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

• Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity

  Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants randomized to the Immediate Treatment group will receive CBT-I treatment immediately after randomization.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Enhanced Sleep Hygiene

OTHER

Participants randomized to the Enhanced Sleep Hygiene (ESH) group will be offered the same CBT-I described above approximately 7 months after being randomized. We will also provide a list of referrals for treatment upon completion of their end of treatment visit (approx. week 11) should they choose to seek treatment sooner. In the interim, they will be provided with two sessions of sleep hygiene / sleep education and four additional meetings including monitoring of sleep and mood symptoms.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: CBT-I

Enhanced Sleep Hygiene; Immediate Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrea Goldstein, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaela Mandler

CONTACT

650-721-6089; kaelam@stanford.edu

Leah Harris

CONTACT

leahharr@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Enrolled participants will be randomized into either the Immediate Treatment group, or the Enhanced Sleep Hygiene group. Both study groups will receive CBT-I.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)