Investigating how sleep therapy affects emotional regulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project explores the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on the brain's emotion regulation network. It aims to confirm whether CBT-I can enhance connectivity between the medial prefrontal cortex and amygdala, potentially reducing depressive symptoms and suicidality. The study will compare outcomes between participants receiving CBT-I and a control group, assessing changes in brain activity related to emotional regulation. This is the second phase of a larger investigation into the relationship between sleep restoration and emotional health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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)

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Andrea Goldstein, PhD — Stanford University
• Study coordinator: Kaela Mandler
• Email: kaelam@stanford.edu
• Phone: 650-721-6089

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.