Clinical trial NCT03041389: Computerized Cognitive Behavioral Therapy Trial for Insomnia in Parkinson Disease
Official title: A Computerized Cognitive Behavioral Therapy Randomized, Controlled, Pilot Trial for Insomnia in Parkinson Disease (The ACCORD-PD Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Related to Specified Disorder
Parkinson Disease
Keywords: Computerized Cognitive Behavioral Therapy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1 ratio), single-blind, parallel-group, controlled study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Pittsburgh Insomnia Rating Scale
timeFrame: 12 weeks
measure: Total Sleep Time
timeFrame: 12 weeks
measure: Patient Global Impression of Improvement
timeFrame: 12 weeks
measure: Fatigue Severity Scale
timeFrame: 12 weeks
measure: Epworth Sleepiness Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Anwar Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: