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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032680
Enrollment
40
Registered
2014-01-10
Start date
2015-08-19
Completion date
2018-09-30
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophrenia and Related Disorders

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.

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.

Interventions

OTHERTreatment 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.

BEHAVIORALWeb-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.

BEHAVIORALIn-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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Goal Attainment ScaleOutcome is assessed at 3, 6, and 12 monthsAt 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.

Countries

United States

Participant flow

Recruitment details

Of 96 veterans screened, 78 met eligibility criteria.

Pre-assignment details

Of the 78 who were screened and met eligibility criteria, 40 consented to participate in the study. 10 of the 40 dropped out before being assigned to an intervention arm. 30 were assigned to an intervention arm.

Participants by arm

ArmCount
Web-based Family Psycho-education Treatment
The e-health/web-based intervention provides: three therapist facilitated on-line group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials. 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.
22
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. 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.
8
Total30

Baseline characteristics

CharacteristicWeb-based Family Psycho-education TreatmentIn-persons Multi-family Psycho-educational TreatmentTotal
Age, Continuous58.8 Years
STANDARD_DEVIATION 10.9
51.4 Years
STANDARD_DEVIATION 11.8
56.8 Years
STANDARD_DEVIATION 11.5
Participant Goal Attainment Scale0 units on a scale
STANDARD_DEVIATION 0
0 units on a scale
STANDARD_DEVIATION 0
0 units on a scale
STANDARD_DEVIATION 0
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants1 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
12 Participants6 Participants18 Participants
Region of Enrollment
United States
22 Participants8 Participants30 Participants
Sex: Female, Male
Female
7 Participants2 Participants9 Participants
Sex: Female, Male
Male
15 Participants6 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 8
other
Total, other adverse events
0 / 220 / 8
serious
Total, serious adverse events
0 / 220 / 8

Outcome results

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.

Time frame: Outcome is assessed at 3, 6, and 12 months

Population: The analyses assessed the highest level that participants achieved on their goal, using the 5 point scale 0, 1, 2, 3, 4, with 4 being the highest achievement level The reported outcomes data indicates the highest level that a participant achieved on their goal during the study, regardless of which timepoint (3, 6, or 12 months) that this occurred.

ArmMeasureGroupValue (NUMBER)
Web-based Family Psycho-education TreatmentGoal Attainment ScaleHighest level achieved was 16.25 percentage of participats
Web-based Family Psycho-education TreatmentGoal Attainment ScaleHighest level achieved was 318.75 percentage of participats
Web-based Family Psycho-education TreatmentGoal Attainment ScaleHighest level achieved was 237.5 percentage of participats
Web-based Family Psycho-education TreatmentGoal Attainment ScaleHighest level achieved was 437.5 percentage of participats
In-persons Multi-family Psycho-educational TreatmentGoal Attainment ScaleHighest level achieved was 457.14 percentage of participats
In-persons Multi-family Psycho-educational TreatmentGoal Attainment ScaleHighest level achieved was 114.29 percentage of participats
In-persons Multi-family Psycho-educational TreatmentGoal Attainment ScaleHighest level achieved was 20 percentage of participats
In-persons Multi-family Psycho-educational TreatmentGoal Attainment ScaleHighest level achieved was 328.57 percentage of participats
Comparison: The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).p-value: 0.3749Cochran-Armitage Trend Test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026