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Comparison of E-health vs. In-person MFG

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ClinicalTrials.gov Identifier: NCT02032680
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Web-based multi-family psychoeducational treatment Behavioral: In-persons multi-family psycho-educational treatment Other: Treatment as usual (TAU) Not Applicable

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'), 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 RR&D 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 aims of this study are to conduct: 1) To conduct a non-inferiority randomized trial of DSW vs. in-person MFG vs. 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) exploratory secondary analyses to identify Veteran and family characteristics that are associated with decreased levels of psychiatric symptoms and caregiver burden; 3) exploratory qualitative analyses to inform a larger implementation of SOAR by identifying barriers, facilitators, VA system requirements, etc. from clinicians providing the treatments, their supervisors, and participants. If successful, SOAR 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of E-Health vs. In-Person Delivered Family Psychoeducation Treatment
Actual Study Start Date : August 19, 2015
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Web-based family psycho-education treatment
The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.
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.

Active Comparator: In-persons multi-family psycho-educational treatment
This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.
Behavioral: In-persons multi-family psycho-educational treatment
This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format.

Treatment as Usual
The Treatment as usual (TAU) group provides a benchmark against which to measure the impact of the two individual interventions (MFG & DSW) independent from each other. Through enhancements of TAU, such as regular monitoring which will be done in the assessment process and by the provision of information to VA psychiatrist when there are concerns or problems with the psychiatric status of their patients, we will be taking reasonable steps to ensure the safety of the participants who are assigned to TAU.
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.




Primary Outcome Measures :
  1. Positive symptoms (Scale for the Assessment of Positive Symptoms) [ Time Frame: Outcome will be assessed at 12 months (end of treatment) ]
    Illness symptom severity will be assessed using the Scale for the Assessment of Positive Symptoms (SAPS)(the primary patient positive symptoms outcome) and the Scale for the Assessment of Negative Symptoms (SANS) (the primary patient negative symptoms outcome).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veterans will be included who:

  • have a DSM-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032680


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Armando J. Rotondi, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02032680    
Other Study ID Numbers: IIR 13-332
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders