Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease
Condition: Insomnia Related to Specified Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Intervention name(s): CCBT-I Group; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized (1:1 ratio), single-blind, parallel-group, controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Computerized Cognitive Behavioral Therapy