Clinical trial NCT03461666: Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
Official title: A Randomized, Open Label, Sleep Hygiene Controlled 6-Week Study to Compare the Efficacy of Four (CBT-I, FOA, Combined CBT-I and FOA and Sleep Hygiene) Different Behavioral Approaches for the Treatment of Adult Subjects With Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Insomnia
Keywords: Primary insomnia
Behavioral treatment of primary insomnia
Focus of attention
cognitive behavioral therapy for insomnia
Lead sponsor: Pacific Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group
Primary purpose: HEALTH_SERVICES_RESEARCH

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 treatment of insomnia. This study is a randomized, open label study, and the participants are asked to assess the benefits they get from the intervention. This study involve 6 weekly in person one-to-one sessions after screening and completion of the 1-week, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administering the treatment. The Research Department will administer the outcome measures. The review of insomnia improvement will be assessed at at end of treatment, 3 months, 6 months and 12 months follow-up.

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 for the treatment of insomnia. This study is a randomized, open label study, the participants are asked to review the benefits they get from the intervention. This study involve 6 weekly sessions after screening and completion of the end of treatment, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will administer study scales during therapy session. The subjective review of insomnia improvement will be assessed at end of treatment, 3 months, 6 months and 12 months follow-up assessment. Subjects are adult who meet, DSM-5 the diagnostic criteria for primary Insomnia.

Inclusion/Exclusion criteria to be assessed at Screening (Visit 1) and Visit 2. For those found eligible who complete the study, participation will include Screening (Visit 1), 6 weekly sessions after screening, and completion of the post-treatment and 6-month followup assessment.

Once subject sign the consent form, subject will be asked inclusion and exclusion criteria and will be given details about the study as per protocol.

Those eligible will be randomly assigned to one of four behavioral treatment approaches. The participant will have six weekly one hour in person sessions in which the assigned treatment will be administered. The participant will be assessed at the end of treatment and again at 6 month followup.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Self Report Sleep Measures
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Puget Sound Psychiatric Center
state: Washington
city: Bothell
country: United States
facility: Puget Sound Psychiatry Center
state: Washington
Study officials:
affiliation: Puget Sound Psychiatry center
name: Max Hines, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cahn BR, Polich J. Meditation states and traits: EEG, ERP, and neuroimaging studies. Psychol Bull. 2006 Mar;132(2):180-211. doi: 10.1037/0033-2909.132.2.180.