Primary InsomniaCEBATINCT03461666
Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
A study testing Cognitive Behavior Therapy-Insomnia, Focus of Attention and Combined-CBT-I and FOA Group in people with Primary Insomnia, run by Pacific Institute of Medical Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Cognitive Behavior Therapy-Insomnia, Focus of Attention and Combined-CBT-I and FOA Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Puget Sound Psychiatric Center
Bothell, Washington, 98011
Puget Sound Psychiatry Center
Bothell, Washington, 98011
About this study
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
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.
Read the 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.
- Conditions
- Primary Insomnia
- Being tested
- Cognitive Behavior Therapy-Insomnia, Focus of Attention, Combined-CBT-I and FOA Group, Sleep Hygiene
- Keywords
- Primary insomnia, Behavioral treatment of primary insomnia, Focus of attention, cognitive behavioral therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy-InsomniaBehavioural
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Focus of AttentionBehavioural
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Combined-CBT-I and FOA GroupBehavioural
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
Sleep HygieneBehavioural
Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy-Insomnia | Active comparator | Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive Behavior Therapy-Insomnia; Behavioral: Focus of Attention; Behavioral: Combined-CBT-I and FOA Group; Behavioral: Sleep Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Report Sleep Measures
SRSM: assess overall quantity of sleep satisfaction on the Self Report Sleep Measures.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Insomnia Severity Index
ISI: assess the severity of insomnia.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start5 Sep 2018
- Primary completion1 Nov 2021
- Study completion1 Jul 2022
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Hines, Ph.D, Principal investigator, Puget Sound Psychiatry center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461666
- Sponsor's protocol ID
- PSPC-17-01
- Acronym
- CEBATI
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2017
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Finding to present in peer review journals
Publications
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.
PubMed 25345689Cahn 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.
PubMed 16536641
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03461666
- Acronym / sponsor ID
- CEBATI / PSPC-17-01
- Conditions
- Primary Insomnia
- Keywords
- Primary insomnia, Behavioral treatment of primary insomnia, Focus of attention, cognitive behavioral therapy for insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Pacific Institute of Medical SciencesUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- parallel group
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy-Insomnia | Active comparator | Behavioral: Cognitive Behavior Therapy-Insomnia, Behavioral: Focus of Attention, Behavioral: Combined-CBT-I and FOA Group, Behavioral: Sleep HygieneParticipants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
| Focus Of Attention | Active comparator | Behavioral: Cognitive Behavior Therapy-Insomnia, Behavioral: Focus of Attention, Behavioral: Combined-CBT-I and FOA Group, Behavioral: Sleep HygieneParticipants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
| Combined-CBT-I and FOA Group | Active comparator | Behavioral: Cognitive Behavior Therapy-Insomnia, Behavioral: Focus of Attention, Behavioral: Combined-CBT-I and FOA Group, Behavioral: Sleep HygieneParticipants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
| Sleep Hygiene | Active comparator | Behavioral: Cognitive Behavior Therapy-Insomnia, Behavioral: Focus of Attention, Behavioral: Combined-CBT-I and FOA Group, Behavioral: Sleep HygieneParticipants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy-InsomniaBehavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. | Behavioural | Cognitive Behavior Therapy-Insomnia, Combined-CBT-I and FOA Group, Focus Of Attention, Sleep Hygiene |
| Focus of AttentionBehavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. | Behavioural | Cognitive Behavior Therapy-Insomnia, Combined-CBT-I and FOA Group, Focus Of Attention, Sleep Hygiene |
| Combined-CBT-I and FOA GroupBehavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. | Behavioural | Cognitive Behavior Therapy-Insomnia, Combined-CBT-I and FOA Group, Focus Of Attention, Sleep Hygiene |
| Sleep HygieneBehavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. | Behavioural | Cognitive Behavior Therapy-Insomnia, Combined-CBT-I and FOA Group, Focus Of Attention, Sleep Hygiene |
Primary outcome
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.
1 secondary outcome
Insomnia Severity Index
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Results publication: PubMed 25345689Becher 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 publication: PubMed 16536641Cahn 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.
- Individual participant dataSharing planned: No. Finding to present in peer review journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Hines, Ph.D principal investigator
Puget Sound Psychiatry center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy-Insomnia, Focus of Attention and Combined-CBT-I and FOA Group in people with Primary Insomnia, run by Pacific Institute of Medical Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Report Sleep Measures (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.