Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease

Not Applicable

Completed

• Conditions: Insomnia Related to Specified Disorder; Parkinson Disease
• Interventions: Behavioral: Control Group; Behavioral: CCBT-I Group

• Registration Number: NCT03041389
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-01-01
• Study Completion: 2016-06-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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.
CCBT-I Group	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.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	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

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