xml: <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/NCT05986604</url>
    </required_header>
    <id_info>
      <org_study_id>TranS-C+MSI vs. TranS-C Alone</org_study_id>
      <nct_id>NCT05986604</nct_id>
    </id_info>
    <brief_title>NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment</brief_title>
    <official_title>NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Berkeley</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Berkeley</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>
        Mental illness is often chronic, severe, and difficult to treat. Though there has been&#xD;
        significant progress towards establishing effective and efficient interventions for&#xD;
        psychological health problems, many individuals do not gain lasting benefits from these&#xD;
        treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings&#xD;
        from the cognitive science literature to improve treatment outcomes. In this study, the&#xD;
        investigators aim to conduct an open trial that includes individuals 50 years and older to&#xD;
        assess if a novel version of the Memory Support Intervention improves sleep and circadian&#xD;
        functioning, reduces functional impairment, and improves patient memory for treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Life expectancy has increased drastically in the United States. Longer life is too often&#xD;
        associated with illness, discomfort, disability, and dependency. Progress toward promoting&#xD;
        health and well-being as we age must include the identification of novel treatment targets&#xD;
        that are safe, powerful, inexpensive, and deployable. The proposed research will test one&#xD;
        such target-patient memory for the contents of treatment.&#xD;
  &#xD;
        Over 5 years, we will recruit adults who are 50 years and older and who are experiencing&#xD;
        sleep and circadian problems (n = 178, including 20% for attrition). Participants will be&#xD;
        randomly allocated to TranS-C plus the MSI (&quot;TranS-C+MSI&quot;) or TranS-C alone via eight&#xD;
        50-minute, weekly, individual sessions. Assessments will be conducted at baseline,&#xD;
        post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).&#xD;
  &#xD;
        Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian&#xD;
        functioning, (b) improves daytime functioning and (c) improves well-being, by comparing the&#xD;
        effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who&#xD;
        receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.&#xD;
  &#xD;
        Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between&#xD;
        treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be&#xD;
        associated with better memory for treatment relative to TranS-C alone, and in turn, better&#xD;
        memory for treatment will be associated with better sleep and circadian functioning&#xD;
        immediately following treatment and at 6FU and 12FU.&#xD;
  &#xD;
        Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory&#xD;
        support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3.&#xD;
        Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older,&#xD;
        have fewer years of education, poorer baseline cognitive functioning and more severe baseline&#xD;
        sleep disruption and sleep-related impairment.&#xD;
  &#xD;
        Exploratory analyses will compare the treatments on (a) patient adherence as well as&#xD;
        patient-rated treatment credibility and utilization of treatment elements and (b)&#xD;
        provider-rated acceptability, appropriateness, and feasibility.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 25, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomly allocated to TranS-C plus the MSI (&quot;TranS-C+MSI&quot;) or TranS-C alone</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System - Sleep Disturbance</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sheehan Disability Scale</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction with Life Scale</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive and Negative Affect Scale</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WHODAS 2.0</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>A measure of functional impairment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Failures Questionnaire</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Epworth Sleepiness Scale</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Memory for Treatment: Past session recall</measure>
      <time_frame>Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]</time_frame>
      <description>Recall on the Patient Treatment Recall Task</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Memory for Treatment: Cumulative recall</measure>
      <time_frame>Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]</time_frame>
      <description>Recall on the Patient Treatment Recall Task</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalization Task Thoughts Applications</measure>
      <time_frame>Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]</time_frame>
      <description>Measures how treatment points have generalized to the participant's thinking and functioning during every day life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalization Task Generalization Scenarios</measure>
      <time_frame>Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]</time_frame>
      <description>Scenarios involving sleep problems are presented to assess generalization of treatment points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Utilization Scale</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Composite Sleep Health Score</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean sleep efficiency (Daily Sleep Diary)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean total wake time (Daily Sleep Diary)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Daily Sleep Diary mean for total wake time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean for total sleep time (Daily Sleep Diary)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up</time_frame>
      <description>Daily Sleep Diary mean for total sleep time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean for total wake time (Actigraphy)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>Actigraphy mean for total wake time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean for total sleep time (Actigraphy)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>Actigraphy mean for total sleep time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean for daytime activity (Actigraphy)</measure>
      <time_frame>Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>Actigraphy mean for daytime activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Acceptability of Intervention Measure</measure>
      <time_frame>Through therapy completion, an average of 8 weeks following baseline</time_frame>
      <description>Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Appropriateness Intervention Measure</measure>
      <time_frame>Through therapy completion, an average of 8 weeks following baseline</time_frame>
      <description>Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Feasibility of Intervention Measure</measure>
      <time_frame>Through therapy completion, an average of 8 weeks following baseline</time_frame>
      <description>Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Provider-rated TranS-C Checklist</measure>
      <time_frame>Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks</time_frame>
      <description>A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Memory Support Treatment Provider Checklist</measure>
      <time_frame>Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks</time_frame>
      <description>A measure of memory support delivered. This is completed by the therapist at the end of every treatment session</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Patient adherence via the TARS</measure>
      <time_frame>Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks</time_frame>
      <description>A measure of patient treatment adherence completed by the therapist at the end of every treatment session</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Memory Support Rating Scale, total amount</measure>
      <time_frame>Randomly selected therapy tapes</time_frame>
      <description>Assesses the total amount of memory support used by a provider via coding of session tapes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Provider level: Memory Support Rating Scale, number of types</measure>
      <time_frame>Randomly selected therapy tapes</time_frame>
      <description>Assesses the number of types of memory support used by a provider via coding of session tapes</description>
    </secondary_outcome>
    <other_outcome>
      <measure>STOP-BANG Questionnaire</measure>
      <time_frame>Baseline only</time_frame>
      <description>Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea</description>
    </other_outcome>
    <other_outcome>
      <measure>Screen for periodic limb movement disorder</measure>
      <time_frame>Baseline only</time_frame>
      <description>Restless Leg Syndrome Questions</description>
    </other_outcome>
    <other_outcome>
      <measure>Semi-structured interview</measure>
      <time_frame>Only at post-treatment which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>Assess patient perceptions of treatment</description>
    </other_outcome>
    <other_outcome>
      <measure>WatchPAT One</measure>
      <time_frame>Baseline only</time_frame>
      <description>For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse events checklist</measure>
      <time_frame>Only at post-treatment which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>To assess any adverse events experienced as a result of participating in the study</description>
    </other_outcome>
    <other_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>Baseline only</time_frame>
      <description>A measure of cognitive functioning/cognitive impairments to determine eligibility</description>
    </other_outcome>
    <other_outcome>
      <measure>Credibility Expectancy Questionnaire</measure>
      <time_frame>At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment</time_frame>
      <description>Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">178</enrollment>
    <condition>Sleep Disorder</condition>
    <condition>Circadian Dysregulation</condition>
    <condition>Memory Impairment</condition>
    <arm_group>
      <arm_group_label>TranS-C+MSI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TranS-C alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Transdiagnostic Sleep and Circadian Intervention will be delivered alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Memory Support Intervention</intervention_name>
      <description>The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.</description>
      <arm_group_label>TranS-C+MSI</arm_group_label>
      <other_name>MSI</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Transdiagnostic Intervention for Sleep and Circadian Dysfunction</intervention_name>
      <description>TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.</description>
      <arm_group_label>TranS-C alone</arm_group_label>
      <arm_group_label>TranS-C+MSI</arm_group_label>
      <other_name>TranS-C</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Aged 50 years and older;&#xD;
  &#xD;
            2. English language fluency;&#xD;
  &#xD;
            3. Experiencing a mobility impairment;&#xD;
  &#xD;
            4. Low income;&#xD;
  &#xD;
            5. Exhibit a sleep or circadian disturbance as determined by endorsing 4 &quot;quite a bit&quot; or&#xD;
               5 &quot;very much&quot; (or the equivalent for reverse scored items) on one or more PROMIS-SD&#xD;
               questions.&#xD;
  &#xD;
            6. 26-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive&#xD;
               impairment.&#xD;
  &#xD;
            7. Consent to regular communications between the research team and the patient's medical&#xD;
               provider/s;&#xD;
  &#xD;
            8. Able/willing to give informed consent.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Severe (AHI&gt;30) or moderate (AHI of 15-30) untreated OSA;&#xD;
  &#xD;
            2. Medical conditions that prevent a participant from comprehending and following the&#xD;
               basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner&#xD;
               that can't be addressed by a cognitive behavioral treatment (e.g., the Structured&#xD;
               Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM&#xD;
               sleep behavior disorder) or that may preclude full participation (e.g., receipt of end&#xD;
               of life care);&#xD;
  &#xD;
            3. Homelessness;&#xD;
  &#xD;
            4. Night shift work &gt;2 nights per week in the past 3 months;&#xD;
  &#xD;
            5. Substance abuse/dependence only if it makes participation in the study unfeasible;&#xD;
  &#xD;
            6. Suicide risk sufficient to preclude treatment on an outpatient basis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Allison Harvey, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Berkeley</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Allison Harvey, PhD</last_name>
      <phone>5106427138</phone>
      <email>aharvey@berkeley.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California, Berkeley</name>
        <address>
          <city>Berkeley</city>
          <state>California</state>
          <zip>94720-1650</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Allison Harvey, PhD</last_name>
        <phone>510-642-7138</phone>
        <email>aharvey@berkeley.edu</email>
      </contact>
      <contact_backup>
        <last_name>Nena Salazar</last_name>
        <phone>‪(925) 421-0083‬</phone>
        <email>n.salazar@berkeley.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Berkeley</investigator_affiliation>
      <investigator_full_name>Allison Harvey</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Chronobiology Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986604
  org study id: TranS-C+MSI vs. TranS-C Alone
  nct id: NCT05986604
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Mental illness is often chronic, severe, and difficult to treat. Though there has been
        significant progress towards establishing effective and efficient interventions for
        psychological health problems, many individuals do not gain lasting benefits from these
        treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings
        from the cognitive science literature to improve treatment outcomes. In this study, the
        investigators aim to conduct an open trial that includes individuals 50 years and older to
        assess if a novel version of the Memory Support Intervention improves sleep and circadian
        functioning, reduces functional impairment, and improves patient memory for treatment.
  Life expectancy has increased drastically in the United States. Longer life is too often
        associated with illness, discomfort, disability, and dependency. Progress toward promoting
        health and well-being as we age must include the identification of novel treatment targets
        that are safe, powerful, inexpensive, and deployable. The proposed research will test one
        such target-patient memory for the contents of treatment.
  
        Over 5 years, we will recruit adults who are 50 years and older and who are experiencing
        sleep and circadian problems (n = 178, including 20% for attrition). Participants will be
        randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight
        50-minute, weekly, individual sessions. Assessments will be conducted at baseline,
        post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).
  
        Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian
        functioning, (b) improves daytime functioning and (c) improves well-being, by comparing the
        effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who
        receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.
  
        Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between
        treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be
        associated with better memory for treatment relative to TranS-C alone, and in turn, better
        memory for treatment will be associated with better sleep and circadian functioning
        immediately following treatment and at 6FU and 12FU.
  
        Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory
        support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3.
        Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older,
        have fewer years of education, poorer baseline cognitive functioning and more severe baseline
        sleep disruption and sleep-related impairment.
  
        Exploratory analyses will compare the treatments on (a) patient adherence as well as
        patient-rated treatment credibility and utilization of treatment elements and (b)
        provider-rated acceptability, appropriateness, and feasibility.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
  measure: Sheehan Disability Scale
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
  measure: Satisfaction with Life Scale
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: 5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life.
  measure: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).
  measure: Positive and Negative Affect Scale
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect
  measure: WHODAS 2.0
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: A measure of functional impairment
  measure: Cognitive Failures Questionnaire
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.
  measure: Epworth Sleepiness Scale
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
  measure: Memory for Treatment: Past session recall
  time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
  description: Recall on the Patient Treatment Recall Task
  measure: Memory for Treatment: Cumulative recall
  time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
  description: Recall on the Patient Treatment Recall Task
  measure: Generalization Task Thoughts Applications
  time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
  description: Measures how treatment points have generalized to the participant's thinking and functioning during every day life
  measure: Generalization Task Generalization Scenarios
  time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
  description: Scenarios involving sleep problems are presented to assess generalization of treatment points
  measure: Utilization Scale
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: 16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).
  measure: Composite Sleep Health Score
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).
  measure: Mean sleep efficiency (Daily Sleep Diary)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime.
  measure: Mean total wake time (Daily Sleep Diary)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Daily Sleep Diary mean for total wake time
  measure: Mean for total sleep time (Daily Sleep Diary)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
  description: Daily Sleep Diary mean for total sleep time
  measure: Mean for total wake time (Actigraphy)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
  description: Actigraphy mean for total wake time
  measure: Mean for total sleep time (Actigraphy)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
  description: Actigraphy mean for total sleep time
  measure: Mean for daytime activity (Actigraphy)
  time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
  description: Actigraphy mean for daytime activity
  measure: Provider level: Acceptability of Intervention Measure
  time frame: Through therapy completion, an average of 8 weeks following baseline
  description: Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire
  measure: Provider level: Appropriateness Intervention Measure
  time frame: Through therapy completion, an average of 8 weeks following baseline
  description: Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
  measure: Provider level: Feasibility of Intervention Measure
  time frame: Through therapy completion, an average of 8 weeks following baseline
  description: Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire
  measure: Provider level: Provider-rated TranS-C Checklist
  time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
  description: A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session
  measure: Provider level: Memory Support Treatment Provider Checklist
  time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
  description: A measure of memory support delivered. This is completed by the therapist at the end of every treatment session
  measure: Provider level: Patient adherence via the TARS
  time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
  description: A measure of patient treatment adherence completed by the therapist at the end of every treatment session
  measure: Provider level: Memory Support Rating Scale, total amount
  time frame: Randomly selected therapy tapes
  description: Assesses the total amount of memory support used by a provider via coding of session tapes
  measure: Provider level: Memory Support Rating Scale, number of types
  time frame: Randomly selected therapy tapes
  description: Assesses the number of types of memory support used by a provider via coding of session tapes
  measure: STOP-BANG Questionnaire
  time frame: Baseline only
  description: Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea
  measure: Screen for periodic limb movement disorder
  time frame: Baseline only
  description: Restless Leg Syndrome Questions
  measure: Semi-structured interview
  time frame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
  description: Assess patient perceptions of treatment
  measure: WatchPAT One
  time frame: Baseline only
  description: For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility
  measure: Adverse events checklist
  time frame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
  description: To assess any adverse events experienced as a result of participating in the study
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: Baseline only
  description: A measure of cognitive functioning/cognitive impairments to determine eligibility
  measure: Credibility Expectancy Questionnaire
  time frame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
  description: Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.
  arm group label: TranS-C+MSI
  arm group type: Experimental
  description: Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention
  arm group label: TranS-C alone
  arm group type: Active Comparator
  description: The Transdiagnostic Sleep and Circadian Intervention will be delivered alone
  intervention type: Behavioral
  intervention name: Memory Support Intervention
  description: The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
  arm group label: TranS-C+MSI
  other name: MSI
  intervention type: Behavioral
  intervention name: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
  description: TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.
  arm group label: TranS-C alone
  arm group label: TranS-C+MSI
  other name: TranS-C
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Allison Harvey, PhD
  role: Principal Investigator
  affiliation: University of California, Berkeley
  last name: Allison Harvey, PhD
  phone: 5106427138
  email: aharvey@berkeley.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Berkeley
  investigator full name: Allison Harvey
  investigator title: Professor
  mesh term: Sleep Wake Disorders
  mesh term: Chronobiology Disorders