Comparison of E-health vs. In-person Multi-Family Group (MFG)
Condition: Schizophrenia; Schizoaffective Disorder; Schizophrenia and Related Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      As specified in the VA Uniform Services Handbook, Family Psycho-Education (FPE) treatment
      must be available to all Veterans with schizophrenia who could benefit, and their family
      members. This includes those receiving care at Community Based Outpatient Clinics (CBOCs),
      and at Psychosocial Rehabilitation and Recovery Centers (PRRCs), whether provided on site, by
      referral, or by telemental health. However, less than 5% of VA medical centers offer FPE.
      Clearly, a major challenge is to devise ways to deliver mental health treatments and services
      to Veterans who need them in ways that meet their needs and preferences. The proposed project
      will compare the use of a website to deliver FPE to that of in-person delivered FPE. The
      findings could have profound implications for the VA's ability to improve the reach, use,
      appeal, and effectiveness of FPE for Veterans with schizophrenia, by using an e-health model
      that facilitates family involvement.
    

Detailed description: 
      In the VA Family Psycho-Educational (FPE) is a component of the Uniform Services standard for
      care of Veterans with schizophrenia and their family members. FPE includes single family
      variants, e.g., Behavioral Family Therapy, which is provided to individual families (consumer
      and family members); and multi-family variants, e.g., Multi-Family Group Psycho-Education
      (MFG-stands for 'Multi-Family Group Psycho-Education'), which is provided to multiple
      families (consumers and family members together) in a single treatment group. To promote the
      availability of FPE to all Veterans who could benefit, the VA began national trainings of
      clinicians in FPE. Despite this training, the proven effectiveness of FPE, and that it is the
      standard for care, it is not widely available to Veterans, is underutilized even where
      available, and can incur relatively high resistance from Veterans and families. Less than 5%
      of VA Medical Centers provide FPE. Further, even where it is available, it reaches a
      relatively small proportion of Veterans who could benefit. Barriers to receiving this
      treatment include the lack of appropriately trained clinicians, the need for Veterans and
      family members to travel to receive these services--this maybe a particularly important
      hurdle for a treatment that meets bi-weekly for a minimum of nine months--the tendency to
      avoid in-person treatment due to the stigma associated with seeking mental health treatment,
      and the difficulty of providing treatments after hours or on weekends when families are more
      likely be able to attend. It is important for the VA to have treatment delivery models that
      maximize the likelihood that all Veterans in need will receive interventions such as FPE,
      including Veterans residing in rural settings, and Veterans who avoid VA settings due to
      stigma. E-health delivery of services has been a focus of the VA as a way to overcome these
      barriers. Specialized web-based approaches have been studied and found to be successful for
      people with schizophrenia, and their families, and can deliver content that is intensive and
      engaging with reduced requirements for staff time.

      The investigators' previous work has developed a model and guidelines to design e-health
      applications for persons with schizophrenia and others with cognitive impairments (e.g.,
      Rotondi, VA Rehabilitation Research and Development D61804R), and developed a highly scalable
      intervention termed Schizophrenia On-line Access to Resources (SOAR) (Rotondi, R01 MH63484).
      SOAR incorporated FPE into a modernized model that: incorporates web-based delivery; provides
      the ability of users to individualize commitment and services to meet varied preferences and
      needs, in order to address prominent reasons for resistance to FPE; and is accessible from
      homes and smart phones. SOAR was highly successful at reducing illness symptoms for persons
      with schizophrenia and improving their and their family members' knowledge of the illness.
      The Daily Support Website (DSW) was created as the next iteration of SOAR, with improvements
      based on what was learned from the original trial.

      The aims of this study are to conduct: 1) a non-inferiority randomized trial of the Daily
      Support Website (DSW) vs. in-person MFG vs. Treatment as usual (TAU) that compares the
      achievement of a personal goal, changes in severity of positive and negative psychiatric
      symptoms, and family psychological burden, during treatment and 3-months post-treatment 2)
      exploratory secondary analyses to identify Veteran and family characteristics that are
      associated with achievement of a personal goal, decreased levels of psychiatric symptoms and
      caregiver burden; 3) exploratory qualitative analyses to inform a larger implementation of
      the DSW by identifying barriers, facilitators, VA system requirements, etc. from clinicians
      providing the treatments, their supervisors, and participants. If successful, the DSW could
      substantially increase the options, availability, utilization, appeal, and effectiveness of
      FPE for Veterans and their families, thereby improving Veteran well-being, recovery, and
      Veteran and family quality of life.
    

Intervention name(s): Web-based multi-family psychoeducational treatment; In-persons Multi-Family Group Psycho-Education treatment; Treatment as usual (TAU)
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.; This intervention will provide the VA's evidence-based MFG. This intervention is delivered to Veterans and their families or other supporters using an in-person format.; Treatment as Usual (TAU) is considered the usual care at the VA. Participants assigned to be in the Treatment as Usual arm will complete assessments at all data collection time points, (baseline, 6, 12, and 15 months.) These participants will not receive any study treatment but will continue to receive their treatment as usual through the VA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment