<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/NCT04426838</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00115210</org_study_id>
    <nct_id>NCT04426838</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad</brief_title>
  <official_title>Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alzheimer's Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</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>
      Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It&#xD;
      contributes to earlier placement of the PLwD in nursing homes and increase the risk for many&#xD;
      psychological and cognitive health issues and poor quality of life for both the PLwD and the&#xD;
      caregivers. Given the potential harmful side effects of medications, non-medication&#xD;
      alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to&#xD;
      improve disturbed sleep in this population. CBTi which includes stimulus control, sleep&#xD;
      compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has&#xD;
      durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep&#xD;
      disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the&#xD;
      PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for&#xD;
      intervention has the potential to lead to improved sleep and health outcomes for both&#xD;
      persons. There is no current published research on CBTi when the PLwD and their caregivers&#xD;
      receive the intervention at the same time; as a result, the researchers will examine the 1)&#xD;
      feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for&#xD;
      community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances.&#xD;
      Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary&#xD;
      efficacy of the intervention will be assessed using objective (actigraphy) and subjective&#xD;
      sleep quality measures. In addition, semi-structured interviews will be conducted to examine&#xD;
      the acceptability and satisfaction with the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience&#xD;
      sleep disturbances, which are distressing for both the PLwD and their caregivers.&#xD;
      Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can&#xD;
      affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep&#xD;
      duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a&#xD;
      myriad of psychological, cognitive, behavioral, and physiological health issues and poor&#xD;
      quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and&#xD;
      the negative health consequences of sleep disturbances on the dyad, there is a critical need&#xD;
      to develop and provide effective interventions to improve their sleep. Pharmacologic&#xD;
      treatment often results in potential harmful side effects like falls and cognitive decline;&#xD;
      therefore, non-pharmacologic approaches are recommended for this population.&#xD;
&#xD;
      Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has&#xD;
      demonstrated effectiveness for improving sleep disturbances in multiple populations, is&#xD;
      delivered in various formats including face-to-face and videoconferencing. Individually, PLwD&#xD;
      and caregivers have successfully deployed behavioral sleep techniques, resulting in improved&#xD;
      sleep quality. However, there is no current published research on CBTi completed&#xD;
      simultaneously by the PLwD-caregiver dyad, and that is exactly what the researchers of this&#xD;
      study seek to do with early-stage individuals and their caregivers. The researchers premise&#xD;
      this effort on the notion that a dyadic intervention can use early-stage individuals'&#xD;
      retained capacity for communication and comprehension to establish in-the-moment agreements&#xD;
      about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in&#xD;
      the PLwD and to pair that with acquired strategies to engender his/her own positive sleep&#xD;
      behaviors.&#xD;
&#xD;
      This project seeks to gather formative and preliminary data on CBTi delivered simultaneously&#xD;
      to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to&#xD;
      determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi&#xD;
      intervention administered to 40 PLwD-caregiver dyads via videoconferencing sessions who will&#xD;
      receive the intervention as a unit. Objective and subjective sleep, depressive symptoms, and&#xD;
      cognitive health data will be collected at baseline, and 1 week and 3 months post-completion&#xD;
      of the intervention.&#xD;
&#xD;
      In community-dwelling PLwD and their caregivers where both persons in the dyad self-report&#xD;
      sleep disturbances, the specific aims for this study are:&#xD;
&#xD;
        1. Assess the feasibility of a video conferencing dyad-based CBTi intervention.&#xD;
&#xD;
        2. Evaluate the acceptability of a video conferencing dyad-based CBTi intervention.&#xD;
&#xD;
        3. Examine the preliminary efficacy of video conferencing CBTi intervention on sleep&#xD;
           quality outcomes including sleep efficiency and perceived sleep quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Actual">March 10, 2023</completion_date>
  <primary_completion_date type="Actual">March 10, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Adherence with Study Interventions</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Attrition from the Study</measure>
    <time_frame>Week 4</time_frame>
    <description>Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability the Intervention</measure>
    <time_frame>Week 5 (1 week post-intervention)</time_frame>
    <description>Acceptability of the interventions will be assessed with a qualitative interview with caregivers after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Disorders Inventory (SDI) - Frequency Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The SDI asks caretakers to report the frequency that eight symptoms of insomnia have been exhibited by the PLwD in the past two weeks. Responses range from 0 to 4 where 0 = not present and 4 = every night. Total frequency scores range from 0 to 32 with higher scores indicating more frequent symptoms of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Disorders Inventory (SDI) - Severity Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The SDI asks caretakers to report the severity of eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 3 where 0 = not present and 3 = marked. Total frequency scores range from 0 to 24 with higher scores indicating more severe symptoms of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The SDI asks caretakers to report the amount of distress they are experiencing due to eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 5 where 0 = not at all and 5 = extremely. Total frequency scores range from 0 to 40 with higher scores indicating more severe caregiver distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insomnia Severity Index Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The Insomnia Severity Index includes 7 questions asking about insomnia during the past two weeks. Responses are given on a scale from 0 to 4 where 0 = no problems and 4 = the most extreme problems. Total scores range from 0 to 28 where higher scores indicate greater problems with insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The SF-12 Health Survey includes 12 items asking respondents how they have been feeling and activities they are doing. Physical and mental health composite scores are computed and range from 0 to 100 where 100 is the highest level of health. The computed composite scores can be compared with a national norm with a mean of 50 and a standard deviation of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score</measure>
    <time_frame>Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)</time_frame>
    <description>The CES-D includes 20 items asking respondents how frequently they felt symptoms of depression during the past week. Responses are given on a scale from 0 to 3 where 0 = rarely or none of the time and 3 = most or all of the time. Certain items are reverse scored so that lower scores equate to lower symptom frequency. Total scores range from 0 to 60 with higher scores indicating greater symptoms of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Duration</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep duration (minutes per night) will be assessed with actigraphy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Fragmentation Index</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. The sleep fragmentation index (number of awakenings and sleep stage shifts divided by sleep time) will be assessed with actigraphy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Onset Latency</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep onset latency (the length of time, in minutes, that it takes to transition from wakefulness to sleep) will be assessed with actigraphy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Wake After Sleep Onset</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake after sleep onset (periods of wakefulness occurring after sleep onset) will be assessed with actigraphy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bed Time</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Bed time will be assessed with actigraphy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Wake Time</measure>
    <time_frame>Baseline (for two weeks prior to the intervention), Day 1 through Week 4</time_frame>
    <description>Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake time will be assessed with actigraphy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Persons living with dementia in a dyad receiving the CBTi intervention in a videoconferencing format.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregivers in a dyad receiving the CBTi intervention in a videoconferencing format.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference</intervention_name>
    <description>The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference.</description>
    <arm_group_label>Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi)</arm_group_label>
    <arm_group_label>PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for the PLwD&#xD;
&#xD;
          -  Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and&#xD;
             related dementias (ADRD)&#xD;
&#xD;
          -  Co-residence with the caregiver in the community&#xD;
&#xD;
          -  Montreal Cognitive Assessment (MOCA) score between 12 and 25&#xD;
&#xD;
          -  Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or&#xD;
             opioids in the past 90 days&#xD;
&#xD;
          -  Presence of sleep problems determined by using the proxy-rated Sleep Disorders&#xD;
             Inventory (presence of at least one sleep disturbance symptom of moderate severity)&#xD;
&#xD;
        Inclusion Criteria for the Caregiver&#xD;
&#xD;
          -  Informal caregivers (family/friends) of co-residing PLwD&#xD;
&#xD;
          -  Providing unpaid assistance, on average 20 hours weekly, for a person in the early&#xD;
             stage of illness who is community-dwelling&#xD;
&#xD;
          -  Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30&#xD;
             minutes more than 3 nights weekly&#xD;
&#xD;
        Inclusion Criteria for the Dyad&#xD;
&#xD;
          -  Tolerate and agrees to wear wrist actigraph&#xD;
&#xD;
          -  Be able to read, speak and understand English&#xD;
&#xD;
          -  Have no uncorrectable vision or hearing deficits that might impede participation&#xD;
&#xD;
        Exclusion Criteria for the PLwD&#xD;
&#xD;
          -  None&#xD;
&#xD;
        Exclusion Criteria for the Caregivers&#xD;
&#xD;
          -  Moderate to severe cognitive impairment defined as MoCA score &lt;17&#xD;
&#xD;
          -  Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule&#xD;
             within the prior three months&#xD;
&#xD;
          -  Presence of an acute medical or psychiatric condition which would interfere with the&#xD;
             subject's ability to realistically follow the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenna Brewster, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goizueta Alzheimer's Disease Research Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Glenna Brewster</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cognitive behavioral therapy for insomnia</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Caregiver</keyword>
  <keyword>Cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT04426838
org study id: IRB00115210
nct id: NCT04426838
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It
      contributes to earlier placement of the PLwD in nursing homes and increase the risk for many
      psychological and cognitive health issues and poor quality of life for both the PLwD and the
      caregivers. Given the potential harmful side effects of medications, non-medication
      alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to
      improve disturbed sleep in this population. CBTi which includes stimulus control, sleep
      compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has
      durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep
      disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the
      PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for
      intervention has the potential to lead to improved sleep and health outcomes for both
      persons. There is no current published research on CBTi when the PLwD and their caregivers
      receive the intervention at the same time; as a result, the researchers will examine the 1)
      feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for
      community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances.
      Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary
      efficacy of the intervention will be assessed using objective (actigraphy) and subjective
      sleep quality measures. In addition, semi-structured interviews will be conducted to examine
      the acceptability and satisfaction with the intervention.
Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience
      sleep disturbances, which are distressing for both the PLwD and their caregivers.
      Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can
      affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep
      duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a
      myriad of psychological, cognitive, behavioral, and physiological health issues and poor
      quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and
      the negative health consequences of sleep disturbances on the dyad, there is a critical need
      to develop and provide effective interventions to improve their sleep. Pharmacologic
      treatment often results in potential harmful side effects like falls and cognitive decline;
      therefore, non-pharmacologic approaches are recommended for this population.

      Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has
      demonstrated effectiveness for improving sleep disturbances in multiple populations, is
      delivered in various formats including face-to-face and videoconferencing. Individually, PLwD
      and caregivers have successfully deployed behavioral sleep techniques, resulting in improved
      sleep quality. However, there is no current published research on CBTi completed
      simultaneously by the PLwD-caregiver dyad, and that is exactly what the researchers of this
      study seek to do with early-stage individuals and their caregivers. The researchers premise
      this effort on the notion that a dyadic intervention can use early-stage individuals'
      retained capacity for communication and comprehension to establish in-the-moment agreements
      about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in
      the PLwD and to pair that with acquired strategies to engender his/her own positive sleep
      behaviors.

      This project seeks to gather formative and preliminary data on CBTi delivered simultaneously
      to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to
      determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi
      intervention administered to 40 PLwD-caregiver dyads via videoconferencing sessions who will
      receive the intervention as a unit. Objective and subjective sleep, depressive symptoms, and
      cognitive health data will be collected at baseline, and 1 week and 3 months post-completion
      of the intervention.

      In community-dwelling PLwD and their caregivers where both persons in the dyad self-report
      sleep disturbances, the specific aims for this study are:

        1. Assess the feasibility of a video conferencing dyad-based CBTi intervention.

        2. Evaluate the acceptability of a video conferencing dyad-based CBTi intervention.

        3. Examine the preliminary efficacy of video conferencing CBTi intervention on sleep
           quality outcomes including sleep efficiency and perceived sleep quality.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Adherence with Study Interventions
time frame: Weeks 1, 2, 3, 4
description: Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks
measure: Percent Attrition from the Study
time frame: Week 4
description: Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.
measure: Acceptability the Intervention
time frame: Week 5 (1 week post-intervention)
description: Acceptability of the interventions will be assessed with a qualitative interview with caregivers after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.
measure: Change in Sleep Disorders Inventory (SDI) - Frequency Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The SDI asks caretakers to report the frequency that eight symptoms of insomnia have been exhibited by the PLwD in the past two weeks. Responses range from 0 to 4 where 0 = not present and 4 = every night. Total frequency scores range from 0 to 32 with higher scores indicating more frequent symptoms of insomnia.
measure: Change in Sleep Disorders Inventory (SDI) - Severity Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The SDI asks caretakers to report the severity of eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 3 where 0 = not present and 3 = marked. Total frequency scores range from 0 to 24 with higher scores indicating more severe symptoms of insomnia.
measure: Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The SDI asks caretakers to report the amount of distress they are experiencing due to eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 5 where 0 = not at all and 5 = extremely. Total frequency scores range from 0 to 40 with higher scores indicating more severe caregiver distress.
measure: Change in Insomnia Severity Index Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The Insomnia Severity Index includes 7 questions asking about insomnia during the past two weeks. Responses are given on a scale from 0 to 4 where 0 = no problems and 4 = the most extreme problems. Total scores range from 0 to 28 where higher scores indicate greater problems with insomnia.
measure: Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The SF-12 Health Survey includes 12 items asking respondents how they have been feeling and activities they are doing. Physical and mental health composite scores are computed and range from 0 to 100 where 100 is the highest level of health. The computed composite scores can be compared with a national norm with a mean of 50 and a standard deviation of 10.
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
description: The CES-D includes 20 items asking respondents how frequently they felt symptoms of depression during the past week. Responses are given on a scale from 0 to 3 where 0 = rarely or none of the time and 3 = most or all of the time. Certain items are reverse scored so that lower scores equate to lower symptom frequency. Total scores range from 0 to 60 with higher scores indicating greater symptoms of depression.
measure: Change in Sleep Duration
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep duration (minutes per night) will be assessed with actigraphy.
measure: Change in Sleep Fragmentation Index
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. The sleep fragmentation index (number of awakenings and sleep stage shifts divided by sleep time) will be assessed with actigraphy.
measure: Change in Sleep Onset Latency
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep onset latency (the length of time, in minutes, that it takes to transition from wakefulness to sleep) will be assessed with actigraphy.
measure: Change in Wake After Sleep Onset
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake after sleep onset (periods of wakefulness occurring after sleep onset) will be assessed with actigraphy.
measure: Change in Bed Time
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Bed time will be assessed with actigraphy.
measure: Change in Wake Time
time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
description: Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake time will be assessed with actigraphy.
arm group label: PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)
arm group type: Experimental
description: Persons living with dementia in a dyad receiving the CBTi intervention in a videoconferencing format.
arm group label: Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi)
arm group type: Experimental
description: Caregivers in a dyad receiving the CBTi intervention in a videoconferencing format.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference
description: The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference.
arm group label: Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi)
arm group label: PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Glenna Brewster, PhD, RN
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Glenna Brewster
investigator title: Assistant Professor
mesh term: Dementia
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No