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

NCT02032680 | Completed Results

• 1 other identifier: IIR 13-332
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophrenia and Related Disorders

Outcome Measures

Primary Outcomes (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.

  Outcome is assessed at 3, 6, and 12 months

Study Arms (3)

Web-based family psycho-education treatment

EXPERIMENTAL

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

In-persons Multi-Family Group Psycho-Education treatment

ACTIVE COMPARATOR

This 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.

Behavioral: In-persons Multi-Family Group Psycho-Education treatment

Treatment as Usual

OTHER

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)

Interventions

Web-based multi-family psychoeducational treatment BEHAVIORAL

This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.

Web-based family psycho-education treatment

In-persons Multi-Family Group Psycho-Education treatment BEHAVIORAL

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.

In-persons Multi-Family Group Psycho-Education treatment

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to speak English
• or use necessary technology.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

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

  PMID: 24375458 RESULT

• 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.

  PMID: 28057610 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The sample for each arm was relatively small. This was basically a pilot evaluation. A larger trial would be necessary to provide a full evaluation of each intervention and the relative advantages and disadvantages of each intervention.

Results Point of Contact

• Title: Dr. Armando Rotondi
• Organization: VA, University of Pittsburgh

ArmandoRotondi1@gmail.com

412-360-2494

Study Officials

• Armando J. Rotondi, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 10, 2014
• Study Start: August 19, 2015
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 month after publication.
• Access Criteria: Outside investigators will follow VA procedures for approval and access.

Locations

US (1)