- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486584
Contingency Management for Problematic Behavior Reduction in the Community
March 3, 2025 updated by: Laureate Institute for Brain Research, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Tulsa's unhoused population grew nearly 7% last year to the highest numbers since the beginning of the COVID-19 pandemic according to Housing Solutions data, an organization that oversees many of the city's efforts to address homelessness.
The primary objective of the study is to decrease disruptive or problematic behaviors by unhoused individuals in the community through monetary incentives.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- Laureate Institute for Brain Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contingency Management
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.
|
Contingency management payment for no disruptive behaviors each week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in disruptive behaviors
Time Frame: 6 months
|
Participants will decrease the frequency of disruptive behaviors in comparison with the 6-month period immediately prior to recruitment
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in disruptive behaviors
Time Frame: 18 months
|
Participants will decrease the frequency of disruptive behaviors in comparison with the 6-month period immediately prior to recruitment
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin Paulus, MD, Laureate Institute for Brain Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2023
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
June 27, 2024
First Submitted That Met QC Criteria
June 27, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 3, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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