Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT06373718

Conditions

Insomnia

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Study Details

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.

Conditions

Insomnia

Depression

Study ID

NCT06373718

Start date

Aug 12, 2024

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Treatment

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

other: 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.

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.

Primary outcome measure

  • Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging [ Time Frame: Assessed at baseline (week 1) and end of treatment (week 13) ]
  • Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging [ Time Frame: Assessed at baseline (week 1) and end of treatment (week 13) ]
  • Change in Beck Depression Inventory [ Time Frame: Assessed at baseline (week 1), throughout treatment phase (weeks 3-11), end of treatment (week 13), and 6-month follow-up (week 39) ]
  • Change in PSG Sleep Efficiency [ Time Frame: Assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 39) ]
  • Change in Insomnia Severity Index (ISI) Scale Score [ Time Frame: Assessed at baseline (week 1), throughout treatment phase (weeks 3-11), end of treatment (week 13), and 6-month follow-up (week 39) ]

Central Contacts and Locations

Central contacts

Kaela Mandler

650-721-6089kaelam@stanford.edu

Leah Harris

leahharr@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kaela Mandler

kaelam@stanford.edu

Principal Investigator:

Andrea Goldstein-Piekarski, PhD

More Information

Sponsor

Stanford University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Insomnia
  • Depression
  • Anxiety
  • CBT-I
  • Cognitive Behavioral Therapy for Insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.