<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/NCT03041389</url>
  </required_header>
  <id_info>
    <org_study_id>13-1388</org_study_id>
    <nct_id>NCT03041389</nct_id>
  </id_info>
  <brief_title>Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease</brief_title>
  <acronym>ACCORD-PD</acronym>
  <official_title>A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and&#xD;
      are often based on pharmacological treatments. It has been shown that the cognitive&#xD;
      behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the&#xD;
      effect of computerized cognitive behavioural therapy on insomnia in PD has not been evaluated&#xD;
      before. The aim of this study is to demonstrate the beneficial effects of 6-weeks of&#xD;
      computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in&#xD;
      Parkinson's disease patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized (1:1 ratio), single-blind, parallel-group, controlled&#xD;
      study on Computerized cognitive behavioral therapy for insomnia (CCBT-I) treatment for PD&#xD;
      patients which evaluates clinical and sleep variables before and after 6-week CCBT-I.&#xD;
&#xD;
      28 subjects with idiopathic PD having insomnia will be recruited for this study. Insomnia&#xD;
      will be defined by &gt;11 Insomnia Severity Index (ISI) scores as 11 was found in a study&#xD;
      examining sensitivity/specificity for ISI cutoffs to be highest % correctly identified in&#xD;
      clinical sample.&#xD;
&#xD;
      After a screening visit, the patients will be randomized to either the CCBT-I 6-week&#xD;
      treatment arm or the control treatment arm. At the end of the screening patients will also&#xD;
      receive 2 enveloped packages of questionnaires to be completed at Week 8 and Week 12 (after&#xD;
      baseline) at home and mailed back to the Principal Investigator (PI) at the study center. The&#xD;
      patients will get a follow-up phone call every week for the treatment period and during Week&#xD;
      8 and Week 12 to remind them to complete evaluations and mail back to the PI.&#xD;
&#xD;
      The Cleveland Clinic Wellness Institute will also send weekly email prompts to the&#xD;
      participants in the CCBT-I treatment arm to ensure/improve compliance with the online sleep&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</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>Randomized (1:1 ratio), single-blind, parallel-group, controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The rater of outcomes questionnaires is blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant difference in the mean Insomnia Severity Index (ISI), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Insomnia Rating Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant difference in the mean Pittsburgh Insomnia Rating Scale (PIRS-20) from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant increase in Total Sleep Time (TST) in PD subjects, from baseline to Week 12, who were randomized to CCBT-I via daily sleep logs in the online program as compared to the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Improvement</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant difference in the number of patients who significantly improved based on Patient Global Impression of Improvement (PGI-I) from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant difference in the mean Fatigue Severity Scale (FSS), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>To demonstrate a significant difference in the mean Epworth Sleepiness Scale (ESS), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Insomnia Related to Specified Disorder</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>CCBT-I Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients who will be randomized to CCBT-I group will get Cleveland Clinic CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program). The program involves a 6-week effective sleep therapy, an online sleep log and daily sleep score, six specially crafted relaxation practices, daily sleep improvement recommendations, activities to help the patient get the sleep needed, daily e-mails from the patient's program coach, daily articles to help the patient get the most out of the program and a mobile application for easy sleep tracking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients who will be randomized control group will be given a reading material only including recommendations about sleep hygiene, stimulus control and sleep restriction. The control group will have access to the CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program), if proven effective, after the study is completed.&#xD;
To identify PD-specific barriers to Internet usage and CCBT-I, all patients at the end of the study or at the time of drop out will have a questionnaire on the barriers to CCBT-I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CCBT-I Group</intervention_name>
    <description>Every patient will have a unique password to access to CCBT-I. The program consists of 5 cores: sleep log, day's lesson, activities, relaxation and progress. Each day, the patients fill in sleep logs before getting the day's lesson. Filling sleep log will be reminded daily by the program coach from Sleep Center.</description>
    <arm_group_label>CCBT-I Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Reading material only including recommendations about sleep hygiene, stimulus control and sleep restriction. Access to the CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program), if proven effective, after the study is completed.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 35-85 years old PD patients, as diagnosed by a Movement Disorders neurologist&#xD;
&#xD;
          2. Male or Female&#xD;
&#xD;
          3. On the stable antiparkinsonian medication in the last 30 days&#xD;
&#xD;
          4. Having insomnia defined by &gt;11 ISI scores&#xD;
&#xD;
          5. Access to a computer and internet&#xD;
&#xD;
          6. Be able to speak, read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dementia as defined by DSM-IV criteria&#xD;
&#xD;
          2. Patients with suboptimally treated depression and significant depressive symptoms as&#xD;
             defined by a PHQ-9 score of &gt;15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild&#xD;
             depression; 10-14 Moderate depression; 15-19 Moderately severe depression;20-27 Severe&#xD;
             depression). Antidepressant medications, prescribed for depression or anxiety, will be&#xD;
             allowed if the patient has been on a stable dose for at least 1 month.&#xD;
&#xD;
          3. Significant hallucinations or psychotic symptoms requiring antipsychotic medications&#xD;
&#xD;
          4. Presence of significant sleep disorders that could be contributing to insomnia such as&#xD;
             known sleep apnea, PLMS, RBD, RLS on screening exam by medical history and&#xD;
             neurological exam.&#xD;
&#xD;
          5. Presence of significant motor fluctuations, especially nocturnal akinesia that could&#xD;
             be contributing to insomnia&#xD;
&#xD;
          6. Use of sedatives, benzodiazepines or sedating anti-depressants (such as mirtazapine,&#xD;
             TCAs), modafinil, stimulants, anticholinergic medications, zolpidem, zopiclone,&#xD;
             eszopiclone, zaleplon will be allowed if the the patient has been on a stable dose for&#xD;
             at least 1 month and if not taken as a sleep aid.&#xD;
&#xD;
          7. Significant renal, hepatic, cardiac and thyroid disease that can interfere with&#xD;
             protocol adherence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anwar Ahmed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Anwar Ahmed, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Computerized Cognitive Behavioral Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD made available to other researchers.</ipd_description>
  </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/NCT03041389
org study id: 13-1388
nct id: NCT03041389
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and
      are often based on pharmacological treatments. It has been shown that the cognitive
      behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the
      effect of computerized cognitive behavioural therapy on insomnia in PD has not been evaluated
      before. The aim of this study is to demonstrate the beneficial effects of 6-weeks of
      computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in
      Parkinson's disease patients.
The investigators propose a randomized (1:1 ratio), single-blind, parallel-group, controlled
      study on Computerized cognitive behavioral therapy for insomnia (CCBT-I) treatment for PD
      patients which evaluates clinical and sleep variables before and after 6-week CCBT-I.

      28 subjects with idiopathic PD having insomnia will be recruited for this study. Insomnia
      will be defined by >11 Insomnia Severity Index (ISI) scores as 11 was found in a study
      examining sensitivity/specificity for ISI cutoffs to be highest % correctly identified in
      clinical sample.

      After a screening visit, the patients will be randomized to either the CCBT-I 6-week
      treatment arm or the control treatment arm. At the end of the screening patients will also
      receive 2 enveloped packages of questionnaires to be completed at Week 8 and Week 12 (after
      baseline) at home and mailed back to the Principal Investigator (PI) at the study center. The
      patients will get a follow-up phone call every week for the treatment period and during Week
      8 and Week 12 to remind them to complete evaluations and mail back to the PI.

      The Cleveland Clinic Wellness Institute will also send weekly email prompts to the
      participants in the CCBT-I treatment arm to ensure/improve compliance with the online sleep
      program.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized (1:1 ratio), single-blind, parallel-group, controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The rater of outcomes questionnaires is blinded.
measure: Insomnia Severity Index
time frame: 12 weeks
description: To demonstrate a significant difference in the mean Insomnia Severity Index (ISI), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group
measure: Pittsburgh Insomnia Rating Scale
time frame: 12 weeks
description: To demonstrate a significant difference in the mean Pittsburgh Insomnia Rating Scale (PIRS-20) from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group
measure: Total Sleep Time
time frame: 12 weeks
description: To demonstrate a significant increase in Total Sleep Time (TST) in PD subjects, from baseline to Week 12, who were randomized to CCBT-I via daily sleep logs in the online program as compared to the control group
measure: Patient Global Impression of Improvement
time frame: 12 weeks
description: To demonstrate a significant difference in the number of patients who significantly improved based on Patient Global Impression of Improvement (PGI-I) from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group
measure: Fatigue Severity Scale
time frame: 12 weeks
description: To demonstrate a significant difference in the mean Fatigue Severity Scale (FSS), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group
measure: Epworth Sleepiness Scale
time frame: 12 weeks
description: To demonstrate a significant difference in the mean Epworth Sleepiness Scale (ESS), from baseline to Week 12 among subjects randomized to CCBT-I treatment versus the control group
arm group label: CCBT-I Group
arm group type: Experimental
description: The patients who will be randomized to CCBT-I group will get Cleveland Clinic CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program). The program involves a 6-week effective sleep therapy, an online sleep log and daily sleep score, six specially crafted relaxation practices, daily sleep improvement recommendations, activities to help the patient get the sleep needed, daily e-mails from the patient's program coach, daily articles to help the patient get the most out of the program and a mobile application for easy sleep tracking.
arm group label: Control Group
arm group type: Active Comparator
description: The patients who will be randomized control group will be given a reading material only including recommendations about sleep hygiene, stimulus control and sleep restriction. The control group will have access to the CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program), if proven effective, after the study is completed.
To identify PD-specific barriers to Internet usage and CCBT-I, all patients at the end of the study or at the time of drop out will have a questionnaire on the barriers to CCBT-I.
intervention type: Behavioral
intervention name: CCBT-I Group
description: Every patient will have a unique password to access to CCBT-I. The program consists of 5 cores: sleep log, day's lesson, activities, relaxation and progress. Each day, the patients fill in sleep logs before getting the day's lesson. Filling sleep log will be reminded daily by the program coach from Sleep Center.
arm group label: CCBT-I Group
intervention type: Behavioral
intervention name: Control Group
description: Reading material only including recommendations about sleep hygiene, stimulus control and sleep restriction. Access to the CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program), if proven effective, after the study is completed.
arm group label: Control Group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Anwar Ahmed, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Anwar Ahmed, MD
investigator title: Principal Investigator
mesh term: Parkinson Disease
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No
ipd description: No IPD made available to other researchers.