A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety

NCT ID: NCT04424407

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-03-23

Brief Summary

Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive symptoms through disruption of brain networks that regulate emotional functions. However, we do not yet know to what degree the emotion regulation brain network is modified by the restoration of sleep, or whether the degree to which a sleep intervention modifies these neural targets mediates reductions in other depressive symptoms including suicidality.

The overall aim is to test the efficacy of an established sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in reducing depressive symptoms through improving emotion regulation brain function in individuals with elevated depressive symptoms and clinically meaningful sleep disturbance.

In this study, we will assess feasibility of recruitment and retention as well as target engagement. Target engagement is defined as the treatment effect on increasing mPFC-amygdala connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation paradigms. Participants will be 70 adults experiencing at least moderate sleep disturbances and who also have elevated anxious and/or depressive symptoms. Emotion distress and sleep disruption will be assessed prior to, and weekly while receiving six Cognitive Behavioral Therapy for Insomnia (CBT-I) across a period of 8 weeks. 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: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-I

Group Type: OTHER

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Participants will meet with a psychologist once a week for six weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.

Interventions

Cognitive Behavioral Therapy for Insomnia

Participants will meet with a psychologist once a week for six weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

Eligibility Criteria

Inclusion Criteria

• Ages 25-60
• Subjective complaint of sleep disturbance for ≥ 3 months (ISI≥10)
• Subjective complaint of depression (BDI≥14) and not at imminent risk for suicide, as measured by CSSRS assessment
• 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
• Medications that would significantly impact sleep, alertness, or mood
• >14 alcoholic drinks per week or >4 drinks per occasion
• General medical condition, disease or neurological disorder that interferes with the assessments or outpatient participation
• Substance abuse or dependence
• Mild traumatic brain injury
• Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols
• Pregnant or breast feeding
• Current or lifetime history of bipolar disorder or psychosis
• Current or or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition
• Received CBT-I within the past year
• Acute or unstable chronic illness
• Current exposure to trauma, or exposure to trauma within the past 3 months
• Working a rotating shift that overlaps with 2400h.
• Individuals who 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

Principal Investigators

Andrea Goldstein-Piekarski, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Original

View Document

Document Type: Statistical Analysis Plan: Revised

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R61MH120245

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-56961

Identifier Type: -

Identifier Source: org_study_id