BACKGROUND/RATIONALE:
For Veterans with schizophrenia the VA strives to provide evidence-based, recovery-oriented, mental health services, and to involve families/supporters in those treatments. As part of this approach to care the VA adopted Family Psycho-Education (FPE) as the standard for care of Veterans with schizophrenia. The only evidence based treatment that includes patients and families is FPE. Despite the importance of this treatment, multiple barriers result in only a small fraction of Veterans and families who could benefit actually receiving this treatment.

E-health delivery can address barriers to availability and utilization of in-person FPE, including the absence of economies of scale in some clinics, CBOCs, or geographic areas due to insufficient numbers of Veterans in need; stigma associated with mental health treatment; lack of clinical expertise at many locations; Veteran cognitive impairments and/or cyclical symptom exacerbations that create barriers to attending in-person treatments; difficulties scheduling meetings when Veterans and families can attend; and travel barriers.
Our on-going work created guidelines to design e-health applications for persons with schizophrenia (e.g., Rotondi, VA RR&D D61804R), and a highly transportable web-based intervention termed Schizophrenia On-line Access to Resources (SOAR) (Rotondi, R01 MH63484).

OBJECTIVE(S):
The objectives of this study are to: 1) conduct a non-inferiority randomized trial of SOAR, in-person MFG, and treatment as usual (TAU) that compares changes in severity of positive and negative psychiatric symptoms, and family psychological burden, during treatment and 3-months post-treatment; 2) conduct exploratory analyses to identify Veteran and family characteristics that are associated with decreased levels of psychiatric symptoms and caregiver burden across the two arms and within each arm (e.g., benefiting from either treatment). These analyses will also look for important moderators and mediators of treatment effects.

METHODS:
This study will conduct a randomized non-inferiority comparative effectiveness trial of SOAR, in-person MFG, and treatment as usual (TAU) with (n=109 total) and their families. Veterans will be included who: have a medical chart diagnosis of schizophrenia or schizoaffective disorder; are 18-65 years old; are not in another family treatment, and; are able to speak and read English at the 5th grade level. Veterans with a diagnosis of SZ or SZA are included because both were included in original evidence-based treatment trials and both are eligible for MFG treatment in the VA. Our initial analyses of the primary dependent measures for Veterans and for family members/supporters will test the mean ratios at time points 12 and 15 months to test for non-inferiority. Then the analyses will use mixed effect regressions with the primary effects of interest the interaction between time of measurement and treatment group.

FINDINGS/RESULTS:
Analysis is ongoing.

IMPACT:
Final results are pending including the impact of this study.

---

External Links for this Project

NIH Reporter

Grant Number: I01HX001443-01
Link: https://reporter.nih.gov/project-details/8674118

---

PUBLICATIONS:

Journal Articles

1. Rotondi AJ, Eack SM, Hanusa BH, Spring MB, Haas GL. Critical design elements of e-health applications for users with severe mental illness: singular focus, simple architecture, prominent contents, explicit navigation, and inclusive hyperlinks. Schizophrenia Bulletin. 2015 Mar 1; 41(2):440-8. [view]
2. Rotondi AJ, Spring MR, Hanusa BH, Eack SM, Haas GL. Designing eHealth Applications to Reduce Cognitive Effort for Persons With Severe Mental Illness: Page Complexity, Navigation Simplicity, and Comprehensibility. JMIR human factors. 2017 Jan 5; 4(1):e1. [view]

DRA: Mental, Cognitive and Behavioral Disorders, Health Systems Science
DRE: Technology Development and Assessment, Treatment - Comparative Effectiveness
Keywords: none
MeSH Terms: none