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

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

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.

Condition or disease	Intervention/treatment	Phase
Primary Insomnia	Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel group
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: September 5, 2018
• Estimated Primary Completion Date: November 1, 2021
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cognitive Behavior Therapy-Insomnia; Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.	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.
Active Comparator: Focus Of Attention; Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.	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.
Active Comparator: Combined-CBT-I and FOA Group; Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.	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.
Active Comparator: Sleep Hygiene; Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Insomnia Severity Index [ Time Frame: through study completion, an average of 1 year ]
   ISI: assess the severity of insomnia.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 72 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

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

Locations

United States, Washington

Puget Sound Psychiatric Center; Enrolling by invitation

Bothell, Washington, United States, 98011

Puget Sound Psychiatry Center; Recruiting

Bothell, Washington, United States, 98011

Contact: Max Hines, Ph.D 425-949-5779 max@pspc.org

Contact: Syed Mustafa, M.D 425-806-5021 sjmustafamd@pspc.org

Principal Investigator: Max Hines, Ph.D

Sponsors and Collaborators

Pacific Institute of Medical Sciences

Investigators

• Principal Investigator: Max Hines, Ph.D; Puget Sound Psychiatry center

  Study Documents (Full-Text)

Documents provided by Pacific Institute of Medical Sciences:

Study Protocol  [PDF] February 12, 2018

Informed Consent Form  [PDF] September 23, 2020

More Information

Publications of Results:

Becher AK, Höhne 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.

Cahn BR, Polich J. Meditation states and traits: EEG, ERP, and neuroimaging studies. Psychol Bull. 2006 Mar;132(2):180-211. Review.

• Responsible Party: Pacific Institute of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03461666
• Other Study ID Numbers: PSPC-17-01
• First Posted: March 12, 2018
• Last Update Posted: September 30, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Finding to present in peer review journals

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pacific Institute of Medical Sciences:

Primary insomnia; Behavioral treatment of primary insomnia; Focus of attention; cognitive behavioral therapy for insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders