Sleep therapy for insomnia and depression and its effect on brain emotion networks
Tests cognitive behavioral therapy for insomnia in adults with insomnia and depression.
Key facts
- Who runs it
- Stanford University
- Where
- Palo Alto, United StatesSee the site
- Trial code
- Registry title
- Sleep Mechanisms Of Regulating Emotions
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 12 Aug 2024
- Expected to end
- Jun 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Cognitive Behavioral Therapy for Insomnia
- Record updated
- 20 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with insomnia and depressive symptoms. It tests a talking therapy for sleep problems called Cognitive Behavioral Therapy for Insomnia (CBT-I).
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- Insomnia for at least 3 months that causes daytime problems or distress (ISI score ≥ 10). Depressive symptoms with a BDI score of ≥ 14.
- Earlier treatment
- You cannot join if you had CBT-I in the past year. You must be willing to stop sleep medicines >1 week and anti-depressants > two weeks before the study starts.
Main reasons for not taking part
- Other sleep disorders, or untreated moderate or worse sleep apnea (AHI ≥ 15)
- Bipolar disorder or psychosis, now or in the past, or serious current suicide risk
- Pregnant or breast feeding
- Heavy alcohol use (>14 drinks per week or > 4 drinks per occasion) or substance abuse
- Acute or unstable chronic illness, or night shift work that overlaps with 2400h
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- General medical condition, disease or neurological disorder that interferes with the assessments
- History of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
- Current or lifetime history of bipolar disorder or psychosis
- Current or expected cognitive behavior therapy or other evidence-based psychotherapies for another condition
- 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
- Substance abuse or dependence
- 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 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Stanford UniversityPalo Alto, United StatesContact: Kaela MandlerTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Immediate TreatmentTreatment being tested
Participants randomized to the Immediate Treatment group will receive CBT-I treatment immediately after randomization.
Treatment: Cognitive Behavioral Therapy for Insomnia
- Enhanced Sleep HygieneOther group
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.
Treatment: Cognitive Behavioral Therapy for Insomnia
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)
- Plain-language title
- Sleep therapy for insomnia and depression and its effect on brain emotion networksGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06373718, who can take part
- Record updated
- 20 April 2026