Status:
TERMINATED
Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
Lead Sponsor:
Pacific Institute of Medical Sciences
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief Summary
This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I); Focus of Attention (FOA); Combined CBT-I and FOA; and Sleep Hygiene (control group) for the t...
Detailed Description
This study compares the efficacy of four different types (Cognitive Behavior Therapy for Insomnia (CBT-I), Focus of Attention (FOA), Combined CBT-I and FOA and Sleep Hygiene) of therapies approaches f...
Eligibility Criteria
Inclusion
- Male and female outpatients who are 18 or older to 72 years. Insomnia Severity Index \> or = 10
- Meet diagnostic criteria for Insomnia Disorder per DSM-5 Willing and able to sign Informed consent form Not planning on moving away from the area for the subsequent 12 weeks.
Exclusion
- Participants who answer "yes" to any of the following will be excluded:
- Females who are lactating or who are pregnant
- Night shift workers, and individuals who nap 3 or more times per week over the preceding month
- Consumption of caffeine beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
- Participation in another trial for insomnia
- Persons unable to complete the study questionnaires and psychological tests
- Persons who are unable to participate for the entire duration of the study, or in the opinion of the investigators, are likely to be non-compliant with the obligations inherent in the trial participation
- Persons self-describing with severe anxiety or severe depression (BDI score of 29 or higher) or severe anxiety (BAI score of 36 or higher).
- Persons with a history of epilepsy, seizures, or dementia
- Any significant, severe or unstable, acute or chronically progressive medical or surgical condition
- Serious head injury or stroke within the past year
- Current alcohol or substance abuse/dependence (must have \>90 days of sobriety)
- Presence of other neurological disorders (e.g., multiple sclerosis, Parkinson's Disease)
- Presence of an untreated or unstable medical or psychiatric comorbid condition (e.g., major depressive disorder or psychotic disorder requiring admission within the last two years). People using psychotropic medication, hypnotic or sedative medications may be included if they are on a stable dosage for the last 2 months prior to the study, if the dose remains stable throughout the study, and if the medication is judged to not interfere with the study outcomes.
- Currently on medications known to produce insomnia (e.g., stimulants)
- Sleep apnea (AHI \>15) or previous diagnosis of sleep apnea. Study participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP and agree to use the device during study participation.
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03461666
Start Date
September 5 2018
End Date
July 1 2022
Last Update
April 5 2023
Active Locations (2)
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1
Puget Sound Psychiatric Center
Bothell, Washington, United States, 98011
2
Puget Sound Psychiatry Center
Bothell, Washington, United States, 98011