NCT05649449

Brief Summary

This study tests a psychosocial intervention called mental health self-directed care by assessing its impact on recovery, mental health status, rehabilitation outcomes, and service costs in the state of Florida.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

December 5, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

self-directed care

Outcome Measures

Primary Outcomes (1)

  • Change in perceived competence for mental health self-management

    Perceived competence is measured with the Perceived Competence Scale that includes 4 items that assess subjects' self-rated ability to manage their mental health and recovery, with scores ranging from 4 to 28, with higher scores indicating greater perceived competence for mental health self-management.

    study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)

Secondary Outcomes (5)

  • Change in met and unmet needs related to multiple life domains

    study entry (pre-intervention), 6-months (intervention mid-point), 12 months (immediate post-intervention)

  • Change in perception of service providers as supportive of client autonomy

    study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)

  • Change in self-rated recovery from mental illness

    study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)

  • Change in employment status

    study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)

  • Change in service costs

    12-month period of study participation

Study Arms (2)

Experimental

EXPERIMENTAL

Participants meet with self-directed care program staff called brokers to receive a program orientation, share perceptions of their current life situation and mental health status, and review past year behavioral health service use as well as participants' views of service helpfulness. This culminates in participants' choice of recovery goals and development of an individual budget to pay for for services and material goods directly related to recovery goals. After budget approval by the program supervisor, brokers make purchases. At quarterly meetings, brokers and participants discuss the latter's progress toward recovery goals and create the next quarter's budget. After receiving 12 months of SDC services, participants are helped to transition back to usual community mental health services.

Behavioral: Self-Directed Care

Control

ACTIVE COMPARATOR

Subjects receive routine mental health care from community agencies consisting of outpatient services coordinated at community behavioral health programs.

Behavioral: Services as usual

Interventions

Participants meet with self-directed care program staff called brokers to receive a program orientation, share perceptions of their current life situation and mental health status, and review past year behavioral health service use as well as participants' views of service helpfulness. This culminates in participants' choice of recovery goals and development of an individual budget to pay for for services and material goods directly related to recovery goals. After budget approval by the program supervisor, brokers make purchases. At quarterly meetings, brokers and participants discuss the latter's progress toward recovery goals and create the next quarter's budget. After receiving 12 months of SDC services, participants are helped to transition back to usual community mental health services.

Experimental

Participants receive usual outpatient psychiatric care delivered at community programs from which the person can choose from an array of services negotiated with the state mental health authority.

Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Serious mental illness
  • Receiving services coordinated by behavioral health managing entity

You may not qualify if:

  • Cognitive impairment preventing informed consent
  • Enrollment in Medicaid/Medicare
  • Representative payeeship
  • Court-mandated treatment
  • Recent substance disorder crisis
  • In residential treatment
  • History of violent behavior in the past 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago, Department of Psychiatry

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research interviewers are blinded to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Self-directed care is a recovery-oriented model of community mental health service delivery in which participants manage a personal budget from which they purchase goods and services, including specific types of mental health care, social supports, and items that allow them to recover their health and emotional wellness and live independently.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 14, 2022

Study Start

September 5, 2017

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations