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Trial record 37 of 237 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Mental Health Services for Prisoners With SMI

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ClinicalTrials.gov Identifier: NCT03713398
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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).

Condition or disease Intervention/treatment Phase
Mental Disorder Behavioral: T4C-SMI Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Mental Health Services for Prisoners With Serious Mental Illnesses
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: T4C-SMI Group
Participants will receive the T4C-SMI intervention, in addition to standard prison mental health services
Behavioral: T4C-SMI
T4C-SMI entails a 25-session, manualized intervention that is delivered in a closed-group format at least twice a week over a three-month period. The intervention curriculum includes three modules: nine sessions on social skills training, five sessions on cognitive restructuring activities, and ten sessions on problem-solving methods. Participants assigned to T4C-SMI receive this intervention in addition to any other prison mental health services that they are otherwise eligible to receive during their incarceration.

No Intervention: Control Group
The control group receives standard prison mental health services



Primary Outcome Measures :
  1. Levels of Aggression Score - Baseline [ Time Frame: At start of intervention ]
    Aggression Questionnaire - Short Form is a 12-item measure. It has four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 5-point Likert scale.

  2. Levels of Aggression Score - 3 Month [ Time Frame: 3 months after baseline interview ]
    Aggression Questionnaire - Short Form is a 12-item measure. It has four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 5-point Likert scale.

  3. Levels of Aggression Score - 6 Month [ Time Frame: 6 months after baseline interview ]
    Aggression Questionnaire - Short Form is a 12-item measure. It has four subscales: physical aggression, verbal aggression, anger, and hostility. Items are scored on a 5-point Likert scale.

  4. Behavioral infractions - Baseline [ Time Frame: At start of intervention ]

    Number of behavioral infractions participants incur:

    Prison records will be used to ascertain the number of behavioral infractions participants incur, the reason for the infraction, and administrative actions taken as a result of the infraction.


  5. Behavioral infractions - 3 Month [ Time Frame: 3 months after baseline interview ]

    Number of behavioral infractions participants incur:

    Prison records will be used to ascertain the number of behavioral infractions participants incur, the reason for the infraction, and administrative actions taken as a result of the infraction.


  6. Behavioral infractions - 6 Month [ Time Frame: 6 months after baseline interview ]

    Number of behavioral infractions participants incur:

    Prison records will be used to ascertain the number of behavioral infractions participants incur, the reason for the infraction, and administrative actions taken as a result of the infraction.


  7. Behavioral infractions - 9 Month [ Time Frame: 9 months after baseline interview ]

    Number of behavioral infractions participants incur:

    Prison records will be used to ascertain the number of behavioral infractions participants incur, the reason for the infraction, and administrative actions taken as a result of the infraction.


  8. Administrative Segregation - Baseline [ Time Frame: At start of intervention ]

    How many times participants are placed in administrative segregation:

    Prison records will be used to determine how many times participants are placed in administrative segregation, the reason for being placed in administrative segregation, and the length of time they are confined in administrative segregation for each placement.


  9. Administrative Segregation - 3 Month [ Time Frame: 3 months after baseline interview ]

    How many times participants are placed in administrative segregation:

    Prison records will be used to determine how many times participants are placed in administrative segregation, the reason for being placed in administrative segregation, and the length of time they are confined in administrative segregation for each placement.


  10. Administrative Segregation - 6 Month [ Time Frame: 6 months after baseline interview ]

    How many times participants are placed in administrative segregation:

    Prison records will be used to determine how many times participants are placed in administrative segregation, the reason for being placed in administrative segregation, and the length of time they are confined in administrative segregation for each placement.


  11. Administrative Segregation - 9 Month [ Time Frame: 9 months after baseline interview ]

    How many times participants are placed in administrative segregation:

    Prison records will be used to determine how many times participants are placed in administrative segregation, the reason for being placed in administrative segregation, and the length of time they are confined in administrative segregation for each placement.



Secondary Outcome Measures :
  1. Interpersonal Problem Solving Score - Baseline [ Time Frame: At start of intervention ]
    The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 7-point Likert scale. It has three scales that will be used in this analysis: problem orientation, problem solving skills, and social problem-solving inventory.

  2. Interpersonal Problem Solving Score - 3 Month [ Time Frame: 3 months after baseline interview ]
    The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 7-point Likert scale. It has three scales that will be used in this analysis: problem orientation, problem solving skills, and social problem-solving inventory.

  3. Interpersonal Problem Solving Score - 6 Month [ Time Frame: 6 months after baseline interview ]
    The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 7-point Likert scale. It has three scales that will be used in this analysis: problem orientation, problem solving skills, and social problem-solving inventory.

  4. Self-administered Interpersonal Problem Solving Score - 6 weeks [ Time Frame: 6 weeks after baseline interview ]
    The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 7-point Likert scale. It has three scales that will be used in this analysis: problem orientation, problem solving skills, and social problem-solving inventory.

  5. Self-administered Interpersonal Problem Solving Score - 18 weeks [ Time Frame: 18 weeks after baseline interview ]
    The Social Problem Solving Inventory - Revised, Long (SPSI-R:L) is a 52-item measure of problem solving skills and problem orientation. Items are measured on a 7-point Likert scale. It has three scales that will be used in this analysis: problem orientation, problem solving skills, and social problem-solving inventory.

  6. Criminal Attitudes Score - Baseline [ Time Frame: At start of intervention ]
    The Measure of Criminal Attitudes and Associates (MCAA) Part B is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates.

  7. Criminal Attitudes Score - 3 Month [ Time Frame: 3 months after baseline interview ]
    The Measure of Criminal Attitudes and Associates (MCAA) Part B is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates.

  8. Criminal Attitudes Score - 6 Month [ Time Frame: 6 months after baseline interview ]
    The Measure of Criminal Attitudes and Associates (MCAA) Part B is a 46-item measure. Responses are recorded in an agree/disagree format. MCAA includes four scales: attitudes toward violence, sentiments of entitlement, antisocial intent, and associates.

  9. Impulsivity Score - Baseline [ Time Frame: At start of intervention ]
    Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure. Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity.

  10. Impulsivity Score - 3 Month [ Time Frame: 3 months after baseline interview ]
    Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure. Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity.

  11. Impulsivity Score - 6 Month [ Time Frame: 6 months after baseline interview ]
    Barratt Impulsiveness Scale (BIS-11) is a 30 item self-report measure. Items scored on a 4-point Likert scale. It is comprised of six subscales including attention, cognitive instability, perseverance, self-control, motor impulsiveness, and cognitive complexity.


Other Outcome Measures:
  1. Psychiatric Symptoms Score - Baseline [ Time Frame: At start of the intervention ]
    The Brief Psychiatric Rating Scale (BPRS) is a 18-item measure. Each item is scored on a scale of 1 (not present) to 7 (extremely severe). Nine of the items are based on participant response, while the other 9-items are based on interviewer observation.

  2. Psychiatric Symptoms Score - 3 Month [ Time Frame: 3 months after baseline interview ]
    The Brief Psychiatric Rating Scale (BPRS) is a 18-item measure. Each item is scored on a scale of 1 (not present) to 7 (extremely severe). Nine of the items are based on participant response, while the other 9-items are based on interviewer observation.

  3. Psychiatric Symptoms Score - 6 Month [ Time Frame: 6 months after baseline interview ]
    The Brief Psychiatric Rating Scale (BPRS) is a 18-item measure. Each item is scored on a scale of 1 (not present) to 7 (extremely severe). Nine of the items are based on participant response, while the other 9-items are based on interviewer observation.

  4. Mental Health Symptoms - 3 Month [ Time Frame: 3 months after baseline interview ]
    The Colorado Symptom Index is a 14-item measure using a 5-point Likert scale. The range for the total scale score is 14-70, with higher scores indicating greater emotional distress.

  5. Mental Health Symptoms - 6 Month [ Time Frame: 6 months after baseline interview ]
    The Colorado Symptom Index is a 14-item measure using a 5-point Likert scale. The range for the total scale score is 14-70, with higher scores indicating greater emotional distress.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 one year prior to study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713398


Contacts
Contact: Amy B Wilson, PhD 9199623598 amyblank@email.unc.edu

Locations
United States, North Carolina
North Carolina Department of Public Safety Not yet recruiting
Raleigh, North Carolina, United States, 27699
Contact: Terri Catlett    919-838-4000    terri.catlett@ncdps.gov   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Amy B Wilson, PhD UNC Chapel Hill

Publications:
Bryant FB, Smith BD. Aggression Questionnaire--Short Form. Psyctests. 2001. doi:10.1037/t09754-000
D'Zurilla TJ, Nezu AM, Maydeu-Olivares A (n.d). Social Problem-Solving Inventory - Revised. Psyctests. doi:10.1037/t05068-000
Stanford MS, Mathias CW, Dougherty DM, Lake SL, Anderson NE, Patton JH. Fifty years of the Barratt Impulsiveness Scale: An update and review. Personality and individual differences. 2009;47(5): 385-395.
Overall JE, Gorham DR. The Brief Psychiatric Rating Scale (BPRS): Recent developments in ascertainment and scaling. Psychopharmacology Bulletin. 1988;24(1): 97-99.

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03713398     History of Changes
Other Study ID Numbers: 16-3154
R34MH111855 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders