Sleep Mechanisms Of Regulating Emotions

NCT ID: NCT06373718

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2027-06-30

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.

Detailed Description

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.

Conditions

Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Treatment

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

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Enhanced Sleep Hygiene

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.

Group Type: OTHER

Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Andrea Goldstein-Piekarski

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pandora A Lam

Role: CONTACT

pal217@stanford.edu

650-497-5130

Facility Contacts

Pandora Lam

Role: primary

pal217@stanford.edu

650-497-5130

Other Identifiers

R33MH120245

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-74553

Identifier Type: -

Identifier Source: org_study_id