BridgeMD
New treatment option for Insomnia
Official title Sleep Mechanisms Of Regulating Emotions
ClinicalTrials.gov ID: NCT06373718
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will...
- Use of psychotropic medications that would significantly impact sleep, alertness, or mood and unwilling or unable to discontinue medication...
- 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
See the full eligibility 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
- 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)...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.