N/A
Completed N=77
Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care
Source: ClinicalTrials.gov NCT03151083 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Program Engagement: Completion of the First Program Module — 17; 12; 16 Participants
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.
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 | — |
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. Informational only — not medical advice.