Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

Objective: 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.

Research Design: The investigators will employ a hybrid implementation-effectiveness study
design through which the investigators will primarily test the effectiveness of the
implementation strategy, while secondarily evaluating the clinical effectiveness of the
SHUTiTM program. The investigators will use a quasi-experimental pre-/post-cohort design
whereby SHUTiTM will initially be implemented using a low-intensity (control) strategy,
followed by implementation using the experimental strategy. The SHUTiTM program's association
with clinical response will be evaluated in an uncontrolled pre-/post-format.

Methodology: 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. The investigators' currently approved protocol (#0002)
involves interviewing VA providers, administrators, and staff in order to expand and modify
the components of this strategy. 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. Use of the program will continue
and implementation outcomes will be gathered over an additional one-year sustainment phase.
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.

Impact/Significance: The development and testing of evidence-based implementation strategies
for Internet-based self-help programs in VA outpatient care is essential given that (1) there
is an increasing number of Internet-based self-help programs providing evidence-based
treatment for a variety of mental and behavioral health disorders, (2) VA has committed to
improving access to care, especially evidence-based and self-care resources, and (3) there is
a Congressional mandate that VA implement Internet-based care. This will be first controlled
trial of an implementation strategy for Internet-based self-help programs in a VA primary
care (PACT/PCMHI) context.

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.