Clinical trial NCT03713398: Mental Health Services for Prisoners With SMI
Official title: Improving Mental Health Services for Prisoners With Serious Mental Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with serious mental illness (SMI) because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison, including improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes).

Detailed description: Interventions are urgently needed to improve the delivery and impact of mental health services for persons with serious mental illnesses (SMI) in prison. Treatments addressing the symptoms of mental illness form a critical component of the continuum of services needed by prisoners with SMI. However, a growing body of literature shows that mental health treatments need to be combined with treatments that directly address criminogenic risk factors (i.e., those factors most closely associated with criminal activities). Despite promising evidence, interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with SMI because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison. This small-scale randomized controlled trail (RCT) explores the potential effectiveness of T4C-SMI towards improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes). The study will also examine whether the treatment targets for T4C-SMI mediate the intervention's impact on outcomes.

The long-term goal is to grow the evidence-base for interventions with the capacity to improve prison and community-reentry outcomes for persons with SMI. This study will provide the data needed to implement a rigorous RCT in a future study and supports NIMH's mission to develop innovative interventions in mental health services.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features
* have moderate to high risk levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
* have at least one year or more remaining on their prison sentence at the time of the screening interview

Exclusion Criteria:

* has participated in T4C-SMI within 6 months prior to study

Primary outcomes:
measure: Change in Levels of Aggression Score From Baseline to Month 3
timeFrame: Baseline, Month 3
measure: Change in Levels of Aggression Score From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Number of Participants With Post Test Behavioral Infractions
timeFrame: End of intervention through Month 9, approximately 6 months total
measure: Median Number of Days in Administrative Segregation
timeFrame: End of intervention through Month 9, approximately 6 months total
Secondary outcomes:
measure: Change in Overall Interpersonal Problem Solving Score
timeFrame: Baseline, Month 3
measure: Change in Overall Criminal Attitudes Score
timeFrame: Baseline, Month 3
measure: Change in Overall Impulsivity Score
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina Department of Public Safety
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Amy B Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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