Clinical trial NCT06486584: Contingency Management for Problematic Behavior Reduction in the Community
Official title: Contingency Management for Problematic Behavior Reduction in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Anosognosia
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: Tulsa Day Center
First posted: 2024-07-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old
2. Diagnosis of Schizophrenia Spectrum, Bipolar, or Related Disorders
3. 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)
4. Receive case management services through TDC
5. Ability to comply with study procedures
6. Willingness to participate in contingency management intervention

Exclusion Criteria:

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

Primary outcomes:
measure: Reduction in disruptive behaviors
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in disruptive behaviors
timeFrame: 18 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Martin Paulus, MD
role: PRINCIPAL_INVESTIGATOR
References: