NCT06486584

Brief Summary

This study aims to determine the feasibility and effectiveness of implementing a contingency management program in a small group of mentally ill, unhoused individuals with schizophrenia or bipolar disorder and anosognosia (a lack of insight into their mental health) in the City of Tulsa. The primary objective of the study is to decrease disruptive or problematic behaviors (e.g. interactions with police, emergency services, hospitals, shelter staff, 911 calls) by unhoused individuals in the community through monetary incentives. Up to 15 participants will meet weekly for 30 minutes with their case manager to discuss progress on life goals ($10) and for having seven days with no disruptive behaviors (or "trouble-free days") per week at each visit, they will receive an additional baseline payment of $20, increasing with continued success in subsequent weeks by $1 per week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable schizophrenia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

June 27, 2024

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in disruptive behaviors

    Participants will decrease the frequency of disruptive behaviors in comparison with the 6-month period immediately prior to recruitment

    6 months

Secondary Outcomes (1)

  • Reduction in disruptive behaviors

    18 months

Study Arms (1)

Contingency Management

EXPERIMENTAL

Meet weekly for 30 minutes with their case manager to discuss progress on life goals ($10) and for having seven days with no disruptive behaviors (or "trouble-free days") per week at each visit, they will receive an additional baseline payment of $20, increasing with continued success in subsequent weeks by $1 per week.

Behavioral: Contingency Management

Interventions

Contingency management payment for no disruptive behaviors each week.

Contingency Management

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years old
  • Diagnosis of Schizophrenia Spectrum, Bipolar, or Related Disorders
  • Presence of Anosognosia (SUMD: Minimum combined score of 4 on questions 1) and 2); Recent (at least \<6 months) history of disruptive behaviors (at least 1 disruptive behavior per week in \>50% of weeks in the 6-month period prior to enrollment)
  • Receive case management services through TDC
  • Ability to comply with study procedures
  • Willingness to participate in contingency management intervention

You may not qualify if:

  • Inability to provide informed consent
  • Unstable medical conditions that would interfere with participation
  • Cognitive impairment that would interfere with participation in the study
  • History of severe aggression or violent behavior posing a risk to study staff or other participants
  • Active suicidal ideation or a history of suicide attempts within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderAgnosia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Paulus, MD

    Laureate Institute for Brain Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

June 20, 2023

Primary Completion

December 15, 2023

Study Completion

December 31, 2024

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations