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AzTrials

SchizophreniaNCT02032680

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

A study testing Web-based multi-family psychoeducational treatment, In-persons Multi-Family Group Psycho-Education treatment and Treatment as usual (TAU) in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Web-based multi-family psychoeducational treatment, In-persons Multi-Family Group Psycho-Education treatment and Treatment as usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
19 Aug 2015to 30 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Unable to speak English
  • or use necessary technology.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Web-based multi-family psychoeducational treatment, In-persons Multi-Family Group Psycho-Education treatment, Treatment as usual (TAU)
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based multi-family psychoeducational treatmentBehavioural

    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 treatmentBehavioural

    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)Other

    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.

Study groups in NCT02032680
Study groupRoleWhat they receive
Web-based family psycho-education treatmentExperimentalThe 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.
Receives: Behavioral: Web-based multi-family psychoeducational treatment
In-persons Multi-Family Group Psycho-Education treatmentActive comparatorThis arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group Psycho-Education (MFG) that is the standard of care in the VA.
Receives: Behavioral: In-persons Multi-Family Group Psycho-Education treatment
Treatment as UsualOtherThe 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.
Receives: Other: Treatment as usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Outcome is assessed at 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study start19 Aug 2015
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032680
Sponsor's protocol ID
IIR 13-332
Status last verified
Sep 2020
First submitted
30 Dec 2013
Last updated
20 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in all articles, after deidentification (text, tables, figures, and appendices) will be shared.

Publications

  • 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 Bull. 2015 Mar;41(2):440-8. doi: 10.1093/schbul/sbt194. Epub 2013 Dec 27.

    PubMed 24375458
  • 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: 10.2196/humanfactors.6221.

    PubMed 28057610

Questions about this trial

What is this clinical trial studying?

A study testing Web-based multi-family psychoeducational treatment, In-persons Multi-Family Group Psycho-Education treatment and Treatment as usual (TAU) in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Goal Attainment Scale (time frame: Outcome is assessed at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02032680, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.

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