Comparison of E-health vs. In-person Multi-Family Group (MFG)

Schizophrenia Clinical Trial

Official title:

Comparison of E-Health vs. In-Person Delivered Family Psychoeducation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032680
• Other study ID #: IIR 13-332
• Status: Completed
• Phase: N/A
• Start date: August 19, 2015
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Veterans will be included who:

• have a DSM-V (Diagnostic and Statistical Manual of Mental Disorders V) diagnosis of schizophrenia or schizoaffective disorder;

• are 18-75 years old; are not in another family treatment,

• and; are able to speak and read English at the 5th grade level.

• The primary support person for the Veteran must be 18 years old

• and able to speak and read English at the 5th grade level.

Exclusion Criteria:

• Unable to speak English

• or use necessary technology.

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Behavioral:
• Web-based multi-family psychoeducational treatment
This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.
• In-persons Multi-Family Group Psycho-Education treatment
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.

Other:
• Treatment as usual (TAU)
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.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Schizophr B — View Citation

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 Hum Factors. 2017 Jan 5;4(1):e1. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal Attainment Scale	At baseline, each participant developed a goal that she or he would work on to achieve as part of involvement in the study. Indicators of the 5 levels (0-4) of achievement, on the Goal Attainment Scale, were developed for each individual participant's goal, with each individual participant. The minimum was 0 (zero), the maximum was 4, and higher scores were better.	Outcome is assessed at 3, 6, and 12 months