Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease

NCT03041389 | Completed

• 1 other identifier: 13-1388
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia Related to Specified Disorder; Parkinson Disease

Keywords

Computerized Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (5)

• Pittsburgh Insomnia Rating Scale

  12 weeks

• Total Sleep Time

  12 weeks

• Patient Global Impression of Improvement

  12 weeks

• Fatigue Severity Scale

  12 weeks

• Epworth Sleepiness Scale

  12 weeks

Study Arms (2)

CCBT-I Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

CCBT-I Group BEHAVIORAL

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.

CCBT-I Group

Control Group BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old PD patients, as diagnosed by a Movement Disorders neurologist
• Male or Female
• On the stable antiparkinsonian medication in the last 30 days
• Having insomnia defined by \>11 ISI scores
• Access to a computer and internet
• Be able to speak, read and understand English

You may not qualify if:

• Dementia as defined by DSM-IV criteria
• 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.
• Significant hallucinations or psychotic symptoms requiring antipsychotic medications
• 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.
• Presence of significant motor fluctuations, especially nocturnal akinesia that could be contributing to insomnia
• 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.
• Significant renal, hepatic, cardiac and thyroid disease that can interfere with protocol adherence

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anwar Ahmed, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The rater of outcomes questionnaires is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized (1:1 ratio), single-blind, parallel-group, controlled study

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 30, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share