Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Changing Lives and Changing Outcomes-9.
- Who it may be relevant to
- Registry conditions: Serious Mental Illness, Psychotic Disorder, Depression, Bipolar. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital: Implementing and Evaluating A Mental Illness and Criminal Risk Focused Intervention for People With Serious Mental Illness
Overview
People with serious mental illness (depression, bipolar, and schizophrenia spectrum disorders) have high rates of repeated criminal legal involvement and psychiatric hospitalizations. Longstanding research shows that in addition to treating clients' symptoms of mental illness, targeting risk factors for legal involvement can help reduce their chances of future incarcerations. Because hospitals are becoming increasingly forensic, treatment programs that address both mental illness and risk factors for legal involvement may be especially helpful in a state hospital setting, like Worcester Recovery Center and Hospital (WRCH). This treatment study offers an adjunctive 9-session intervention, Changing Lives and Changing Outcomes-9 (CLCO-9), for patients at WRCH; this program is designed to help people with serious mental illness who are involved in the legal system increase their awareness of their mental health and reduce their chances of future legal involvement. The investigators are proposing a treatment study testing the use of the CLCO-9 group intervention with patients with serious mental illness with current or previous criminal legal involvement at Worcester Recovery Center and Hospital (WRCH). The study has three aims: 1. Evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH 2. Evaluate CLCO-9's effectiveness on improving patient's self-reported mental health, and behavioral indicators of mental health and risk factors for legal involvement 3. Explore changes in WRCH clinicians' knowledge and attitudes about treating risk factors for criminal legal involvement. To test these aims, the research team will employ a two-phase study. In the first phase, the researchers will implement the intervention and make necessary adjustments to maximize the success of the implementation. In the second phase, the researchers will evaluate the treatment program's effectiveness in producing change from pre- to post-treatment. All patient participants in this study will receive the intervention. The projected sample size is about 20 treatment completers and 4 to 8 group leaders.
Detailed description
In this treatment study, the investigators propose to implement and evaluate a 9-session intervention, cognitive-behavioral intervention, Changing Lives and Changing Outcomes-9 (CLCO-9), for patients at Worcester Recovery Center and Hospital (WRCH) with serious mental illness (i.e., depression, bipolar, and psychotic disorders) with current or previous legal involvement.
The CLCO-9 groups will be led by WRCH clinical staff/trainees who have competed a clinical training in the CLCO-9 intervention led by Dr. Scanlon (PI). This study is comprised of two parts: a clinical phase, and then the effectiveness phase (see Section 5.7 Study Procedures). The study is guided by the following aims:
Aim 1 will evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH.
The researchers hypothesize the implementation will demonstrate feasibility based on the number of patients who agree to join the group and attendance. The researchers anticipate approximately 40 patients will agree to participate in the study, with a projected sample size of 20 treatment completers (i.e., patient participants who attended 5 or more of the 9 group sessions and post-treatment measures). Using transcriptions from consultation calls with group leaders on clinical and implementation issues, the research team will also explore barriers and facilitators of the intervention's feasibility.
The researchers hypothesize that group leader participants will report high levels of session fidelity to the treatment program per session fidelity checklists (i.e., ≥ 75% of session content covered, on average, per session).
The researchers hypothesize patient participants will report satisfaction with CLCO-9 treatment sessions (per the Client Satisfaction Questionnare-8).
The researchers will also explore patient engagement in each session, per group leader participant report on a scale of 1 (disengaged) to 5 (exemplary). The research team will collect patients' session homework to explore homework completion as another indicator of engagement.
Aim 2 will evaluate the CLCO-9's effectiveness in improving patient-reported and behavioral indicators of mental health and criminal risk.
From pre-to post-treatment, the researchers hypothesize improvements in patient-reported emotional distress (per the Modified Colorado Symptom Index), aggression and hostility (per the Bus-Perry Aggression Questionnaire), criminal thinking (per the Psychological Inventory of Criminal Thinking Styles-Short Form), antisocial attitudes (per the Measure of Criminal Attitudes and Associates Part B), and knowledge of treatment content (per the CLCO-9 knowledge quiz) will improve from pre- to post-treatment.
The investigators hypothesize that, per WRCH chart review, behavioral outcomes will show reduced Broset Violence Checklist scores and fewer restraints/seclusions from before to immediately after treatment. The research team also hypothesizes treatment recipients will show improved treatment engagement (i.e., attending more treatment meetings and other groups) across treatment.
Aim 3 will evaluate the changes in WRCH CLCO-9 clinician knowledge and attitudes about treating criminal risk.
The investigators hypothesize that clinicians will show increased knowledge (per the Knowledge about Addressing Criminal Risk quiz) and attitudes (per the Staff Responses to Attitude scale) on addressing criminal risk among patients with SMI after leading the CLCO-9 groups. Change will be calculated by comparing pre-training survey data, post-training survey data, and follow-up survey data after group leaders complete their first and last groups.
Interventions
- Behavioral Changing Lives and Changing Outcomes-9
A brief, cognitive therapy-based intervention for people with mental illness and legal system involvement.
Primary outcome measures
- Buss-Perry Aggression Questionnaire [Time frame: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)]
- Modified Colorado Symptom Index [Time frame: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)]
- Psychological Inventory of Criminal Thinking Styles-Short Form [Time frame: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)]
- Measure of Criminal Attitudes and Associates [Time frame: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)]
- CLCO-9 knowledge quiz [Time frame: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)]
Secondary outcome measures (6)
- Feasibility of implementation [Time frame: From patient recruitment until study ends (anticipated to be about 6 months after recruitment begins)]
- Treatment fidelity [Time frame: Measures after each session for the duration of treatment offered as part of the study (anticipated: about 6 months from recruitment start to study end)]
- Client Satisfaction Questionnare-8 [Time frame: After each session for the duration of treatment offered during the study (anticipated to be about 6 months)]
- Broset Violence Checklist scores [Time frame: One month before starting treatment to after completing study, which is anticipated to be about 7 weeks after baseline (e.g., after completing post-treatment assessments or discharge, whichever comes first).]
- Patient restraint/seclusion events [Time frame: One month before starting treatment to after completing study, which is anticipated to be about 7 weeks after baseline (e.g., after completing post-treatment assessments or discharge, whichever comes first).]
- Patient engagement in other treatment meetings/groups [Time frame: One month before starting treatment to after completing study, which is anticipated to be about 7 weeks after baseline (e.g., after completing post-treatment assessments or discharge, whichever comes first).]
Eligibility criteria
Inclusion criteria
- Currently hospitalized at Worcester Recovery Center and Hospital (WRCH)
- At least 18 years old
- Self-reported current or past legal involvement
- Speaks English
- For patients without a legally authorized representative (LAR): demonstrate capacity to consent per the Capacity Assessment Record (CAR).
- For patients with an LAR: assent to participate.
Exclusion criteria
- Hospital status that does not permit group attendance (e.g., room-based seclusion)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Worcester Recovery Center and Hospital — Worcester
Identifiers
NCT: NCT07359157 · 2025P000801