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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RX001836-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| VA Maryland Health Care System | FED |
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The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
Specific Aim 1: Develop empirically-derived guidelines for the clinical tailoring of CBT-I materials and procedures for Veterans with psychotic disorders through an iterative process with input from Veteran clients, CBT-I experts and providers, as well as those with expertise in psychotic disorders.
Specific Aim 2: Establish the acceptability of CBT-I for Veterans with psychotic disorders and insomnia when delivered using guidelines developed in Specific Aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 Veterans with psychosis and insomnia.
Specific Aim 3: Conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of CBT-I in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Experimental | CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime. |
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| Health and Wellness | Active Comparator | Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Behavioral | CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity. | Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity. | Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks. |
| Veterans RAND 36-Item Health Survey Mental Component Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A. Klingaman, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18840034 | Background | Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004. | |
| 24005883 | Background | Bramoweth AD, Germain A. Deployment-related insomnia in military personnel and veterans. Curr Psychiatry Rep. 2013 Oct;15(10):401. doi: 10.1007/s11920-013-0401-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy-Insomnia | Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime. |
| FG001 | Health and Wellness | Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy-Insomnia | Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Index (ISI) | ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
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From baseline to an average of 22 weeks per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy-Insomnia | Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A participant wore a watch device according to the protocol and experienced skin irritation where the device was worn. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A Klingaman PhD | Department of Veterans Affairs | 410-259-7810 | elizabeth.klingaman@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Apr 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2020 | Apr 20, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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|
| Health and Wellness | Behavioral | Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). |
|
Veterans RAND 36-Item Health Survey score Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental quality of life. |
| Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
| Veterans RAND 36-Item Health Survey Mental Component Score | Veterans RAND 36-Item Health Survey Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental health quality of life. | Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks. |
| World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | WHO-DAS score; scores range from 0 to 100 where 100 is full disability. | Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
| World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | WHO-DAS score; scores range from 0 to 100 where 100 is full disability. | Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks. |
| 26279058 | Background | Klingaman EA, Palmer-Bacon J, Bennett ME, Rowland LM. Sleep Disorders Among People With Schizophrenia: Emerging Research. Curr Psychiatry Rep. 2015 Oct;17(10):79. doi: 10.1007/s11920-015-0616-7. |
| 23423416 | Background | Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193. |
| 16448292 | Background | Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3. |
| 21367359 | Background | Myers E, Startup H, Freeman D. Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: a pilot trial. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):330-6. doi: 10.1016/j.jbtep.2011.02.004. Epub 2011 Mar 2. |
| 14982330 | Background | Dopke CA, Lehner RK, Wells AM. Cognitive-behavioral group therapy for insomnia in individuals with serious mental illnesses: a preliminary evaluation. Psychiatr Rehabil J. 2004 Winter;27(3):235-42. doi: 10.2975/27.2004.235.242. |
| BG001 | Health and Wellness | Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index | Scale ranges from 0-28, with higher scores indicating more severe insomnia. | Mean | Standard Deviation | units on a scale |
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| OG001 | Health and Wellness | Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). |
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| Secondary | Insomnia Severity Index (ISI) | ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks. |
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| Secondary | Veterans RAND 36-Item Health Survey Mental Component Score | Veterans RAND 36-Item Health Survey score Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental quality of life. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
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| Secondary | Veterans RAND 36-Item Health Survey Mental Component Score | Veterans RAND 36-Item Health Survey Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental health quality of life. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks. |
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| Secondary | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | WHO-DAS score; scores range from 0 to 100 where 100 is full disability. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. |
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| Secondary | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | WHO-DAS score; scores range from 0 to 100 where 100 is full disability. | Posted | Mean | Standard Deviation | units on a scale | Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks. |
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| 2 |
| 26 |
| 0 |
| 26 |
| 1 |
| 26 |
| EG001 | Health and Wellness | Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating). | 0 | 21 | 0 | 21 | 0 | 21 |
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| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |