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

Stanford University

Status

Completed

Conditions

Insomnia

Depression

Treatments

Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04424407

R61MH120245 (U.S. NIH Grant/Contract)

IRB-56961

Details and patient eligibility

About

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-amydgala 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.

Enrollment

51 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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.
Presence of suicidal ideations representing imminent risk as determined by the empirically-supported, standardized suicide risk assessment" to the exclusion criteria
Individuals who are not CPAP adherent or have untreated OSA of moderate severity or worse (AHI ≥ 15)