Clinical Trial

Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital

Study acronym: CLCO-9
Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-07-01 -> 2027-05-01 2026-08-13
minor Completion pushed: 2026-07-01 -> 2027-05-01 2026-08-13
Trial Details
NCT Number NCT07359157
Lead Sponsor Massachusetts General Hospital
Collaborators: Worcester Recovery Center and Hospital
Conditions Serious Mental Illness, Psychotic Disorder, Depression, Bipolar
Enrollment 40 participants
Start Date 2026-02-05
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-12