Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06373718

Sleep Mechanisms Of Regulating Emotions

Led by Stanford University · Updated on 2026-04-20

120

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sleep Mechanisms Of Regulating Emotions

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 65
  • Subjective complaint of insomnia with daytime impairment or distress (Insomnia Severity Index  10)
  • Insomnia lasting 3 months or more
  • Subjective depressive symptoms with Beck Depression Inventory score  14
  • Fluent and literate in English
  • Provide written informed consent
  • Reside within 60 miles of Stanford University
Not Eligible

You will not qualify if you...

  • Other sleep or circadian rhythm disorders significantly affecting sleep
  • Use of psychotropic medications impacting sleep, alertness, or mood, unwilling or unable to stop them >2 weeks (antidepressants) or >1 week (sleep meds) before baseline
  • Excessive alcohol use (>14 drinks/week or >4 drinks per occasion)
  • Suicidal ideation with imminent risk
  • Medical, neurological, or general conditions interfering with assessments
  • Substance abuse or dependence
  • Significant head trauma with lasting neurological deficits or brain abnormalities, or recent traumatic brain injury within 2 months
  • Severe vision, hearing, or hand movement impairments affecting study participation
  • Pregnant or breastfeeding
  • Current or past bipolar disorder or psychosis
  • Current or expected cognitive behavioral therapy or other evidence-based psychotherapy for another condition
  • Received CBT for insomnia within the past year
  • Acute or unstable chronic illness affecting study participation
  • Recent trauma exposure within 3 months
  • Rotating shift work overlapping midnight
  • High risk for sleep apnea with non-adherence to CPAP or untreated moderate to severe obstructive sleep apnea (AHI  15)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

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Research Team

K

Kaela Mandler

CONTACT

L

Leah Harris

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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