NCT03041389

Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease

A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Related to Specified Disorder
• Parkinson Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-06-30
• First posted: 2017-02-02
• Last updated: 2017-02-02