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Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease (ACCORD-PD)

Primary Purpose

Insomnia Related to Specified Disorder, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CCBT-I Group
Control Group
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Related to Specified Disorder focused on measuring Computerized Cognitive Behavioral Therapy

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 35-85 years old PD patients, as diagnosed by a Movement Disorders neurologist
  2. Male or Female
  3. On the stable antiparkinsonian medication in the last 30 days
  4. Having insomnia defined by >11 ISI scores
  5. Access to a computer and internet
  6. Be able to speak, read and understand English

Exclusion Criteria:

  1. Dementia as defined by DSM-IV criteria
  2. Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of >15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression;20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 1 month.
  3. Significant hallucinations or psychotic symptoms requiring antipsychotic medications
  4. Presence of significant sleep disorders that could be contributing to insomnia such as known sleep apnea, PLMS, RBD, RLS on screening exam by medical history and neurological exam.
  5. Presence of significant motor fluctuations, especially nocturnal akinesia that could be contributing to insomnia
  6. Use of sedatives, benzodiazepines or sedating anti-depressants (such as mirtazapine, TCAs), modafinil, stimulants, anticholinergic medications, zolpidem, zopiclone, eszopiclone, zaleplon will be allowed if the the patient has been on a stable dose for at least 1 month and if not taken as a sleep aid.
  7. Significant renal, hepatic, cardiac and thyroid disease that can interfere with protocol adherence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CCBT-I Group

    Control Group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Insomnia Severity Index
    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

    Secondary Outcome Measures

    Pittsburgh Insomnia Rating Scale
    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
    Total Sleep Time
    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
    Patient Global Impression of Improvement
    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
    Fatigue Severity Scale
    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
    Epworth Sleepiness Scale
    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

    Full Information

    First Posted
    February 1, 2017
    Last Updated
    February 1, 2017
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041389
    Brief Title
    Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease
    Acronym
    ACCORD-PD
    Official Title
    A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia Related to Specified Disorder, Parkinson Disease
    Keywords
    Computerized Cognitive Behavioral Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized (1:1 ratio), single-blind, parallel-group, controlled study
    Masking
    Outcomes Assessor
    Masking Description
    The rater of outcomes questionnaires is blinded.
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CCBT-I Group
    Arm Type
    Experimental
    Arm 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 Title
    Control Group
    Arm Type
    Active Comparator
    Arm 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(s)
    CCBT-I Group
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control Group
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Insomnia Severity Index
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Pittsburgh Insomnia Rating Scale
    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
    Time Frame
    12 weeks
    Title
    Total Sleep Time
    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
    Time Frame
    12 weeks
    Title
    Patient Global Impression of Improvement
    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
    Time Frame
    12 weeks
    Title
    Fatigue Severity Scale
    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
    Time Frame
    12 weeks
    Title
    Epworth Sleepiness Scale
    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
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 35-85 years old PD patients, as diagnosed by a Movement Disorders neurologist Male or Female On the stable antiparkinsonian medication in the last 30 days Having insomnia defined by >11 ISI scores Access to a computer and internet Be able to speak, read and understand English Exclusion Criteria: Dementia as defined by DSM-IV criteria Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of >15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression;20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 1 month. Significant hallucinations or psychotic symptoms requiring antipsychotic medications Presence of significant sleep disorders that could be contributing to insomnia such as known sleep apnea, PLMS, RBD, RLS on screening exam by medical history and neurological exam. Presence of significant motor fluctuations, especially nocturnal akinesia that could be contributing to insomnia Use of sedatives, benzodiazepines or sedating anti-depressants (such as mirtazapine, TCAs), modafinil, stimulants, anticholinergic medications, zolpidem, zopiclone, eszopiclone, zaleplon will be allowed if the the patient has been on a stable dose for at least 1 month and if not taken as a sleep aid. Significant renal, hepatic, cardiac and thyroid disease that can interfere with protocol adherence
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anwar Ahmed, MD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No IPD made available to other researchers.

    Learn more about this trial

    Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease

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