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

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ClinicalTrials.gov Identifier: NCT03461666
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pacific Institute of Medical Sciences

Tracking Information
First Submitted Date  ICMJE December 22, 2017
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
Self Report Sleep Measures [ Time Frame: through study completion, an average of 1 year ]
SRSM: assess overall quantity of sleep satisfaction on the Self Report Sleep Measures.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
Insomnia Severity Index [ Time Frame: through study completion, an average of 1 year ]
ISI: assess the severity of insomnia.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
parallel group
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • Behavioral: Cognitive Behavior Therapy-Insomnia
    Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
  • Behavioral: Focus of Attention
    Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
  • Behavioral: Combined-CBT-I and FOA Group
    Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
  • Behavioral: Sleep Hygiene
    Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Study Arms  ICMJE
  • Active Comparator: Cognitive Behavior Therapy-Insomnia
    Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
    Interventions:
    • Behavioral: Cognitive Behavior Therapy-Insomnia
    • Behavioral: Focus of Attention
    • Behavioral: Combined-CBT-I and FOA Group
    • Behavioral: Sleep Hygiene
  • Active Comparator: Focus Of Attention
    Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
    Interventions:
    • Behavioral: Cognitive Behavior Therapy-Insomnia
    • Behavioral: Focus of Attention
    • Behavioral: Combined-CBT-I and FOA Group
    • Behavioral: Sleep Hygiene
  • Active Comparator: Combined-CBT-I and FOA Group
    Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
    Interventions:
    • Behavioral: Cognitive Behavior Therapy-Insomnia
    • Behavioral: Focus of Attention
    • Behavioral: Combined-CBT-I and FOA Group
    • Behavioral: Sleep Hygiene
  • Active Comparator: Sleep Hygiene
    Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.
    Interventions:
    • Behavioral: Cognitive Behavior Therapy-Insomnia
    • Behavioral: Focus of Attention
    • Behavioral: Combined-CBT-I and FOA Group
    • Behavioral: Sleep Hygiene
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Max Hines, Ph.D 425-949-5779/ 425-223-2304 max@pspc.org
Contact: Syed Mustafa, M.D 425-806-5021 sjmustafamd@pspc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03461666
Other Study ID Numbers  ICMJE PSPC-17-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Finding to present in peer review journals
Responsible Party Pacific Institute of Medical Sciences
Study Sponsor  ICMJE Pacific Institute of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Max Hines, Ph.D Puget Sound Psychiatry center
PRS Account Pacific Institute of Medical Sciences
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP