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The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based Cognitive Behavioral Therapy for Insomnia | Experimental | This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based Cognitive Behavioral Therapy for Insomnia | Behavioral | This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (Total), Change From Baseline to Follow-up | Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia. | pre-intervention, intervention completion (expected average of 7 weeks) |
| Completion of All 7 Modules of the Intervention | Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program. | on average 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
A single subject completed informed consent procedures and signed the informed consent document, but then was found not to meet exclusion criteria on review of the medical record. The individual was disenrolled.
100 Individuals were recruited between October 2013 and May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet-based Cognitive Behavioral Therapy for Insomnia | This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Veterans recieving care at the VA Connecticut out patient Substance Use Disorders Clinic
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet-based Cognitive Behavioral Therapy for Insomnia | This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (Total), Change From Baseline to Follow-up | Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia. | The number of individuals provided access to the program and reporting baseline and follow-up data | Posted | Mean | Standard Deviation | units on a scale | pre-intervention, intervention completion (expected average of 7 weeks) |
|
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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 | Internet-based Cognitive Behavioral Therapy for Insomnia | This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Hermes | VA Connecticut Healthcare system | 203 932 5711 | 7422 | eric.hermes@va.gov |
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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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|
| years |
|
| Sex: Female, Male | gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Completion of All 7 Modules of the Intervention | Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program. | Posted | Number | participants | on average 7 weeks |
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| 0 |
| 51 |
| 0 |
| 51 |
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| D001523 |
| Mental Disorders |