RECRUITING

Sleep Mechanisms of Regulating Emotions

Conditions

Insomnia Depression Anxiety CBT-I Cognitive Behavioral Therapy for Insomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)

Quick Facts

Study Start:2024-08-31

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06373718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females of any racial or ethnic group, aged 25-60 * 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) 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)

Inclusion Criteria

Exclusion Criteria

* Males and females of any racial or ethnic group, aged 25-60
* 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) 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)

Contacts and Locations

Study Contact

Pandora A Lam

CONTACT

650-497-5130

pal217@stanford.edu

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-31

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-08-31

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Insomnia
Depression
Anxiety
CBT-I
Cognitive Behavioral Therapy for Insomnia

Additional Relevant MeSH Terms

Insomnia
Depression