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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. COVID Complications.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavior Therapy-Insomnia | Active Comparator | Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
|
| Focus Of Attention | Active Comparator | Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
|
| Combined-CBT-I and FOA Group | Active Comparator | Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
|
| Sleep Hygiene | Active Comparator | Participants receive 6 one hour in person behavioral psycho-intervention sessions from a treatment provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy-Insomnia | Behavioral | Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | ISI: assess the severity of insomnia. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Hines, Ph.D | Puget Sound Psychiatry center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puget Sound Psychiatric Center | Bothell | Washington | 98011 | United States | ||
| Puget Sound Psychiatry Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25345689 | Result | 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. | |
| 16536641 | 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. |
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Finding to present in peer review journals
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2018 | Mar 10, 2018 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2020 | Sep 23, 2020 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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parallel group
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| Focus of Attention | Behavioral | Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. |
|
| Combined-CBT-I and FOA Group | Behavioral | Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. |
|
| Sleep Hygiene | Behavioral | Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each. |
|
| Bothell |
| Washington |
| 98011 |
| United States |
| D001523 |
| Mental Disorders |