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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
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.
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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