Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease (ACCORD-PD)

• ClinicalTrials.gov Identifier: NCT03041389
• Recruitment Status: Completed
• First Posted: February 2, 2017
• Last Update Posted: February 2, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Anwar Ahmed, MD, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Insomnia Related to Specified Disorder; Parkinson Disease	Behavioral: CCBT-I Group; Behavioral: Control Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized (1:1 ratio), single-blind, parallel-group, controlled study
• Masking: Single (Outcomes Assessor)
• Masking Description: The rater of outcomes questionnaires is blinded.
• Primary Purpose: Treatment
• Official Title: A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: January 1, 2016
• Actual Study Completion Date: June 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Insomnia Severity Index [ Time Frame: 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 :

1. Pittsburgh Insomnia Rating Scale [ Time Frame: 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
2. Total Sleep Time [ Time Frame: 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
3. Patient Global Impression of Improvement [ Time Frame: 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
4. Fatigue Severity Scale [ Time Frame: 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
5. Epworth Sleepiness Scale [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Anwar Ahmed, MD; The Cleveland Clinic

More Information

• Responsible Party: Anwar Ahmed, MD, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03041389
• Other Study ID Numbers: 13-1388
• First Posted: February 2, 2017
• Last Update Posted: February 2, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No IPD made available to other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anwar Ahmed, MD, The Cleveland Clinic:

Computerized Cognitive Behavioral Therapy

Additional relevant MeSH terms:

Parkinson Disease; Sleep Initiation and Maintenance Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders