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NCT03151083 · ClinicalTrials.gov registry record · NA
Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care
A NA study of Insomnia, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT03151083 is a NA study of Insomnia that has completed, run by VA Office of Research and Development. The registered enrollment target is 77 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03151083, a NA study of Insomnia, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods. The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, S
Conditions Studied
Interventions
- BEHAVIORAL Internet-based Self-help Insomnia Intervention
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2021-06-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03151083
The ClinicalTrials.gov registry entry for NCT03151083 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (55% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Internet-based Self-help Insomnia Intervention is the first listed.
NCT03151083 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT03151083 about?
NCT03151083 is a clinical study titled "Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care". Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT...
What is the current status of trial NCT03151083?
This trial is currently completed. It is a NA study. The enrollment target is 77 participants. The study started on 2017-05-30. Estimated completion is 2021-06-01.
What conditions does trial NCT03151083 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT03151083?
The interventions under investigation include: Internet-based Self-help Insomnia Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03151083?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03151083 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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