<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424407</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-56961</org_study_id>
    <secondary_id>R61MH120245</secondary_id>
    <nct_id>NCT04424407</nct_id>
  </id_info>
  <brief_title>A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety</brief_title>
  <official_title>A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive&#xD;
      symptoms through disruption of brain networks that regulate emotional functions. However, we&#xD;
      do not yet know to what degree the emotion regulation brain network is modified by the&#xD;
      restoration of sleep, or whether the degree to which a sleep intervention modifies these&#xD;
      neural targets mediates reductions in other depressive symptoms including suicidality.&#xD;
&#xD;
      The overall aim is to test the efficacy of an established sleep intervention (Cognitive&#xD;
      Behavioral Therapy for Insomnia (CBT-I)) in reducing depressive symptoms through improving&#xD;
      emotion regulation brain function in individuals with elevated depressive symptoms and&#xD;
      clinically meaningful sleep disturbance.&#xD;
&#xD;
      In this study, we will assess feasibility of recruitment and retention as well as target&#xD;
      engagement. Target engagement is defined as the treatment effect on increasing mPFC-amygala&#xD;
      connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation&#xD;
      paradigms. Participants will be 70 adults experiencing at least moderate sleep disturbances&#xD;
      and who also have elevated anxious and/or depressive symptoms. Emotion distress and sleep&#xD;
      disruption will be assessed prior to, and weekly while receiving six Cognitive Behavioral&#xD;
      Therapy for Insomnia (CBT-I) across a period of 8 weeks. CBT-I improves sleep patterns&#xD;
      through a combination of sleep restriction, stimulus control, mindfulness training, cognitive&#xD;
      therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Using fMRI&#xD;
      scanning, emotion regulation network neural targets will be assayed prior to and following&#xD;
      completion of CBT-I treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2021</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a single-armed trial. All participants will receive Cognitive Behavioral Therapy for Insomnia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit activation will be quantified by blood flow in regions of interest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit connectivity will be quantified by the correlation of the blood flow between regions of interest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Beck Depression Inventory</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe).&#xD;
The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PSG Sleep Efficiency</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Sleep efficiency (SE) is the percentage of total time in bed actually spent sleeping. Based on the overnight PSG sleep recording, SE will be calculated as the total time (minutes) spent asleep (sum of Stages N1, N2, N3, and REM) divided by the total time (minutes) in bed, and multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Columbia Suicide Severity Rating Scale</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>The Columbia Suicide Severity Rating Scale is a 12-item checklist that was designed to quantify the severity of suicidal ideation and behavior. It is composed of two parts. The first six questions ask about suicidal ideation and behavior in the past month while the last six questions ask about suicidal ideation and behavior since the last visit. The CSSRS has been proven to be reliable and valid. It has also been shown to have high sensitivity and specificity to the different suicidal behavior classifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Sleep Onset Latency (SOL) is the time (minutes) from &quot;lights out&quot; to actually falling asleep (sleep onset).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph Number of Arousals as a Measure of Sleep Continuity</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Number of Arousals is determined by number of times of awakening as seen on the actigraph data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Sleep Onset Latency (SOL) is the time (minutes) from &quot;lights out&quot; or start of total recording time, to actually falling asleep as indicated by EEG changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSG Number of Arousals as a Measure of Sleep Architecture</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Number of Arousals is determined by number of times of awakening by EEG changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset) measured by EEG changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Total Sleep Time (TST) is the total time (minutes) spent asleep, from the start of sleep onsetto sleep offset, subtracting any periods of wakefulness. TST includes stages N1, N2, N3, and REM sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.&#xD;
Duration of non-rapid eye movement (NREM) sleep includes stages N1, N2, and N3, and is measured in minutes. The duration of sleep outside of those stages that is associated with specific EEG stages is REM sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Physiology measured by PSG</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Topographical EEG power spectral density analysis associated with sleep stages will be calculated in the Delta (0.5-Hz), Theta (4-7Hz), Alpha (7-11Hz), Sigma (12-15Hz), Beta-1 (15-20Hz), Beta-2 (20-35Hz) and Gamma (35-45Hz) bands, according to published methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insomnia Severity Index (ISI) Scale Score</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social and Occupational Functioning Assessment Scale (SOFAS)</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>The SOFAS is a clinician-rated, global rating scale of overall level of current functioning based on social and occupational functioning. The scoring considers impairments in functioning directly related to physical and/or mental impairments. Scores range from 0 - 100, with lower scores indicating lower levels of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in World Health Organization quality of life assessment (WHOQoL)</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>The WHOQOL-BRIEF is a 26-item brief version of the WHOQOL, that measures quality of life based on six domains: physical health, psychological state, level of independence, social relations, environment, and spirituality/religion/personal beliefs. Four general items about subjective overall QOL and health are also included. Only domain and general item scores are calculated in the WHOQOL-BREF. Items are scored on scales of 1 to 5, and higher scores indicate higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Anxiety Inventory</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms.&#xD;
Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG</measure>
    <time_frame>Assessed at week 0 and week 11</time_frame>
    <description>RSA is the phenomenon of an increased heart rate during inhalation and a decreased heart rate during exhalation. Since these fluctuations are controlled mainly by vagal influences on the heart, RSA serves as a reliable metric for measuring parasympathetic activity. RSA has been proven to be a reliable measure of emotion regulation and emotional responding in numerous studies.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Insomnia</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia</intervention_name>
    <description>Participants will meet with a psychologist once a week for six weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.</description>
    <arm_group_label>CBT-I</arm_group_label>
    <other_name>CBT-I</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 25-60&#xD;
&#xD;
          -  Subjective complaint of sleep disturbance for ≥ 3 months (ISI&gt;15)&#xD;
&#xD;
          -  Subjective complaint of depression (BDI≥14) and not at imminent risk for suicide, as&#xD;
             measured by CSSRS assessment&#xD;
&#xD;
          -  Fluent and literate in English&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Reside within 60 miles of Stanford University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other sleep or circadian rhythm disorders&#xD;
&#xD;
          -  Medications that would significantly impact sleep, alertness, or mood&#xD;
&#xD;
          -  &gt;14 alcoholic drinks per week or &gt;4 drinks per occasion&#xD;
&#xD;
          -  General medical condition, disease or neurological disorder that interferes with the&#xD;
             assessments or outpatient participation&#xD;
&#xD;
          -  Substance abuse or dependence&#xD;
&#xD;
          -  Mild traumatic brain injury&#xD;
&#xD;
          -  Severe impediment to vision, hearing and/or hand movement, likely to interfere with&#xD;
             the ability to follow study protocols&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Current or lifetime history of bipolar disorder or psychosis&#xD;
&#xD;
          -  Current or or expected cognitive behavior therapy or other evidence-based&#xD;
             psychotherapies for another condition&#xD;
&#xD;
          -  Received CBT-I within the past year&#xD;
&#xD;
          -  Acute or unstable chronic illness&#xD;
&#xD;
          -  Current exposure to trauma, or exposure to trauma within the past 3 months&#xD;
&#xD;
          -  Working a rotating shift that overlaps with 2400h.&#xD;
&#xD;
          -  Presence of suicidal ideations representing imminent risk as determined by the&#xD;
             empirically-supported, standardized suicide risk assessment&quot; to the exclusion criteria&#xD;
&#xD;
          -  Individuals who are not CPAP adherent or have untreated OSA of moderate severity or&#xD;
             worse (AHI ≥ 15)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Goldstein-Piekarski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pandora Lam</last_name>
    <phone>650-497-5130</phone>
    <email>pal217@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olivia Magana</last_name>
    <phone>650-723-2011</phone>
    <email>hv3478@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pandora Lam</last_name>
      <phone>650-497-5130</phone>
      <email>pal217@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Olivia Magana</last_name>
      <phone>650-723-2011</phone>
      <email>hv3478@stanford.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Andrea Goldstein-Piekarski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Andrea Goldstein-Piekarski</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>CBT-I</keyword>
  <keyword>Cognitive Behavioral Therapy for Insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424407
org study id: IRB-56961
secondary id: R61MH120245
nct id: NCT04424407
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive
      symptoms through disruption of brain networks that regulate emotional functions. However, we
      do not yet know to what degree the emotion regulation brain network is modified by the
      restoration of sleep, or whether the degree to which a sleep intervention modifies these
      neural targets mediates reductions in other depressive symptoms including suicidality.

      The overall aim is to test the efficacy of an established sleep intervention (Cognitive
      Behavioral Therapy for Insomnia (CBT-I)) in reducing depressive symptoms through improving
      emotion regulation brain function in individuals with elevated depressive symptoms and
      clinically meaningful sleep disturbance.

      In this study, we will assess feasibility of recruitment and retention as well as target
      engagement. Target engagement is defined as the treatment effect on increasing mPFC-amygala
      connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation
      paradigms. Participants will be 70 adults experiencing at least moderate sleep disturbances
      and who also have elevated anxious and/or depressive symptoms. Emotion distress and sleep
      disruption will be assessed prior to, and weekly while receiving six Cognitive Behavioral
      Therapy for Insomnia (CBT-I) across a period of 8 weeks. CBT-I improves sleep patterns
      through a combination of sleep restriction, stimulus control, mindfulness training, cognitive
      therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Using fMRI
      scanning, emotion regulation network neural targets will be assayed prior to and following
      completion of CBT-I treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a single-armed trial. All participants will receive Cognitive Behavioral Therapy for Insomnia
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging
time frame: Assessed at week 0 and week 11
description: During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit activation will be quantified by blood flow in regions of interest.
measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
time frame: Assessed at week 0 and week 11
description: During functional magnetic resonance imaging the Emotion Regulation Network will be engaged by emotional tasks, and circuit connectivity will be quantified by the correlation of the blood flow between regions of interest.
measure: Change in Beck Depression Inventory
time frame: Assessed at week 0 and week 11
description: This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe).
The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.
measure: Change in PSG Sleep Efficiency
time frame: Assessed at week 0 and week 11
description: Sleep efficiency (SE) is the percentage of total time in bed actually spent sleeping. Based on the overnight PSG sleep recording, SE will be calculated as the total time (minutes) spent asleep (sum of Stages N1, N2, N3, and REM) divided by the total time (minutes) in bed, and multiplied by 100.
measure: Change in Columbia Suicide Severity Rating Scale
time frame: Assessed at week 0 and week 11
description: The Columbia Suicide Severity Rating Scale is a 12-item checklist that was designed to quantify the severity of suicidal ideation and behavior. It is composed of two parts. The first six questions ask about suicidal ideation and behavior in the past month while the last six questions ask about suicidal ideation and behavior since the last visit. The CSSRS has been proven to be reliable and valid. It has also been shown to have high sensitivity and specificity to the different suicidal behavior classifications.
measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity
time frame: Assessed at week 0 and week 11
description: Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset).
measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity
time frame: Assessed at week 0 and week 11
description: Number of Arousals is determined by number of times of awakening as seen on the actigraph data.
measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity
time frame: Assessed at week 0 and week 11
description: Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).
measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity
time frame: Assessed at week 0 and week 11
description: Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.
measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity
time frame: Assessed at week 0 and week 11
description: Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture
time frame: Assessed at week 0 and week 11
description: Sleep Onset Latency (SOL) is the time (minutes) from "lights out" or start of total recording time, to actually falling asleep as indicated by EEG changes.
measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture
time frame: Assessed at week 0 and week 11
description: Number of Arousals is determined by number of times of awakening by EEG changes.
measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture
time frame: Assessed at week 0 and week 11
description: Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset) measured by EEG changes.
measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture
time frame: Assessed at week 0 and week 11
description: Total Sleep Time (TST) is the total time (minutes) spent asleep, from the start of sleep onsetto sleep offset, subtracting any periods of wakefulness. TST includes stages N1, N2, N3, and REM sleep.
measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture
time frame: Assessed at week 0 and week 11
description: Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
Duration of non-rapid eye movement (NREM) sleep includes stages N1, N2, and N3, and is measured in minutes. The duration of sleep outside of those stages that is associated with specific EEG stages is REM sleep.
measure: Change in Sleep Physiology measured by PSG
time frame: Assessed at week 0 and week 11
description: Topographical EEG power spectral density analysis associated with sleep stages will be calculated in the Delta (0.5-Hz), Theta (4-7Hz), Alpha (7-11Hz), Sigma (12-15Hz), Beta-1 (15-20Hz), Beta-2 (20-35Hz) and Gamma (35-45Hz) bands, according to published methods.
measure: Change in Insomnia Severity Index (ISI) Scale Score
time frame: Assessed at week 0 and week 11
description: Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.
measure: Change in Social and Occupational Functioning Assessment Scale (SOFAS)
time frame: Assessed at week 0 and week 11
description: The SOFAS is a clinician-rated, global rating scale of overall level of current functioning based on social and occupational functioning. The scoring considers impairments in functioning directly related to physical and/or mental impairments. Scores range from 0 - 100, with lower scores indicating lower levels of functioning.
measure: Change in World Health Organization quality of life assessment (WHOQoL)
time frame: Assessed at week 0 and week 11
description: The WHOQOL-BRIEF is a 26-item brief version of the WHOQOL, that measures quality of life based on six domains: physical health, psychological state, level of independence, social relations, environment, and spirituality/religion/personal beliefs. Four general items about subjective overall QOL and health are also included. Only domain and general item scores are calculated in the WHOQOL-BREF. Items are scored on scales of 1 to 5, and higher scores indicate higher quality of life.
measure: Change in Beck Anxiety Inventory
time frame: Assessed at week 0 and week 11
description: The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms.
Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.
measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG
time frame: Assessed at week 0 and week 11
description: RSA is the phenomenon of an increased heart rate during inhalation and a decreased heart rate during exhalation. Since these fluctuations are controlled mainly by vagal influences on the heart, RSA serves as a reliable metric for measuring parasympathetic activity. RSA has been proven to be a reliable measure of emotion regulation and emotional responding in numerous studies.
arm group label: CBT-I
arm group type: Other
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia
description: Participants will meet with a psychologist once a week for six weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.
arm group label: CBT-I
other name: CBT-I
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Andrea Goldstein-Piekarski, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Pandora Lam
phone: 650-497-5130
email: pal217@stanford.edu
last name: Olivia Magana
phone: 650-723-2011
email: hv3478@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Andrea Goldstein-Piekarski
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No