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Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia (CEBATI)

Primary Purpose

Primary Insomnia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy-Insomnia
Focus of Attention
Combined-CBT-I and FOA Group
Sleep Hygiene
Sponsored by
Pacific Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Primary Insomnia focused on measuring Primary insomnia, Behavioral treatment of primary insomnia, Focus of attention, cognitive behavioral therapy for insomnia

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Puget Sound Psychiatric Center
  • Puget Sound Psychiatry Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cognitive Behavior Therapy-Insomnia

Focus Of Attention

Combined-CBT-I and FOA Group

Sleep Hygiene

Arm Description

Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.

Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.

Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.

Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.

Outcomes

Primary Outcome Measures

Self Report Sleep Measures
SRSM: assess overall quantity of sleep satisfaction on the Self Report Sleep Measures.

Secondary Outcome Measures

Insomnia Severity Index
ISI: assess the severity of insomnia.

Full Information

First Posted
December 22, 2017
Last Updated
March 31, 2023
Sponsor
Pacific Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03461666
Brief Title
Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
Acronym
CEBATI
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacific Institute of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia, Behavioral treatment of primary insomnia, Focus of attention, cognitive behavioral therapy for insomnia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavior Therapy-Insomnia
Arm Type
Active Comparator
Arm Description
Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
Arm Title
Focus Of Attention
Arm Type
Active Comparator
Arm Description
Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
Arm Title
Combined-CBT-I and FOA Group
Arm Type
Active Comparator
Arm Description
Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
Arm Title
Sleep Hygiene
Arm Type
Active Comparator
Arm Description
Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy-Insomnia
Intervention Description
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Intervention Type
Behavioral
Intervention Name(s)
Focus of Attention
Intervention Description
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Intervention Type
Behavioral
Intervention Name(s)
Combined-CBT-I and FOA Group
Intervention Description
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene
Intervention Description
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Primary Outcome Measure Information:
Title
Self Report Sleep Measures
Description
SRSM: assess overall quantity of sleep satisfaction on the Self Report Sleep Measures.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
ISI: assess the severity of insomnia.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Hines, Ph.D
Organizational Affiliation
Puget Sound Psychiatry center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puget Sound Psychiatric Center
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Puget Sound Psychiatry Center
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Finding to present in peer review journals
Citations:
PubMed Identifier
25345689
Citation
Becher AK, Hohne M, Axmacher N, Chaieb L, Elger CE, Fell J. Intracranial electroencephalography power and phase synchronization changes during monaural and binaural beat stimulation. Eur J Neurosci. 2015 Jan;41(2):254-63. doi: 10.1111/ejn.12760. Epub 2014 Oct 25.
Results Reference
result
PubMed Identifier
16536641
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.
Results Reference
result

Learn more about this trial

Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

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