N/A
N=77
Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03151083 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Program Engagement: Completion of the First Program Module — 17; 12; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet-based Self-help Insomnia Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Engagement: Completion of the First Program Module |
17; 12; 16 | — |
| SECONDARY Program Completion |
10; 7; 7 | — |
| SECONDARY Provider Adoption |
31; 26; 34 | — |
| SECONDARY Insomnia Severity Index |
4.3 | — |
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, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.
Eligibility Criteria
Inclusion Criteria
- Patients Receiving care from a VA Connecticut West Haven PACT/PCMHI Provider
- Diagnosed with insomnia lasting 3 months by the PACT provider, as evidenced by referral by the provider for access to the SHUTiTM program
- Able to provide valid informed consent, as evidenced by answering questions indicating their understanding of the content of the Informed Consent Document
- Willing to participate in an internet-based self-help program for insomnia after the access to and requirements of the program are explained to them
- English-speaking (The SHUTiTM program is only available in English)
Exclusion Criteria
- Evidence of acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month, including suicidality, homicidally, mania, or psychotic decompensation.
- Evidence of a conservator of person either verbally reported by the patient or upon inspection of the medical record.
Data sourced from ClinicalTrials.gov (NCT03151083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.