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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041389
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Anwar Ahmed, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Insomnia Related to Specified Disorder Parkinson Disease Behavioral: CCBT-I Group Behavioral: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized (1:1 ratio), single-blind, parallel-group, controlled study
Masking: Single (Outcomes Assessor)
Masking Description: The rater of outcomes questionnaires is blinded.
Primary Purpose: Treatment
Official Title: A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CCBT-I Group
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.
Behavioral: CCBT-I Group
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.

Active Comparator: Control Group

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.

Behavioral: Control Group
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 Measures :
  1. Insomnia Severity Index [ Time Frame: 12 weeks ]
    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 :
  1. Pittsburgh Insomnia Rating Scale [ Time Frame: 12 weeks ]
    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

  2. Total Sleep Time [ Time Frame: 12 weeks ]
    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

  3. Patient Global Impression of Improvement [ Time Frame: 12 weeks ]
    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

  4. Fatigue Severity Scale [ Time Frame: 12 weeks ]
    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

  5. Epworth Sleepiness Scale [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041389


Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Anwar Ahmed, MD The Cleveland Clinic
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Responsible Party: Anwar Ahmed, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03041389    
Other Study ID Numbers: 13-1388
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anwar Ahmed, MD, The Cleveland Clinic:
Computerized Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Parkinson Disease
Sleep Initiation and Maintenance Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders