Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

NCT03461666 | Terminated

• 1 other identifier: PSPC-17-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self Report Sleep Measures

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

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Insomnia Severity Index

  through study completion, an average of 1 year

Study Arms (4)

Cognitive Behavior Therapy-Insomnia

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene

Focus Of Attention

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene

Combined-CBT-I and FOA Group

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene

Sleep Hygiene

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene

Interventions

Cognitive Behavior Therapy-Insomnia BEHAVIORAL

Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.

Cognitive Behavior Therapy-Insomnia; Combined-CBT-I and FOA Group; Focus Of Attention; Sleep Hygiene

Focus of Attention BEHAVIORAL

Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.

Cognitive Behavior Therapy-Insomnia; Combined-CBT-I and FOA Group; Focus Of Attention; Sleep Hygiene

Combined-CBT-I and FOA Group BEHAVIORAL

Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.

Cognitive Behavior Therapy-Insomnia; Combined-CBT-I and FOA Group; Focus Of Attention; Sleep Hygiene

Sleep Hygiene BEHAVIORAL

Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.

Cognitive Behavior Therapy-Insomnia; Combined-CBT-I and FOA Group; Focus Of Attention; Sleep Hygiene

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pacific Institute of Medical Sciences: lead

Study Sites (2)

Puget Sound Psychiatric Center

Bothell, Washington, 98011, United States

Location

Puget Sound Psychiatry Center

Bothell, Washington, 98011, United States

Location

Related Publications (2)

• 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.

  PMID: 25345689 RESULT

• 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.

  PMID: 16536641 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Max Hines, Ph.D

  Puget Sound Psychiatry center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel group

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: March 12, 2018
• Study Start: September 5, 2018
• Primary Completion: November 1, 2021
• Study Completion: July 1, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)