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

NCT07359157 | Recruiting

• 1 other identifier: 2025P000801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH
2. 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. 3.Explore changes in WRCH clinicians' knowledge and attitudes about treating risk factors for criminal legal involvement.

Conditions

Serious Mental Illness; Psychotic Disorder; Depression; Bipolar

Keywords

serious mental illness; criminogenic risk; criminal legal involvement; treatment; forensic; state hospital

Outcome Measures

Primary Outcomes (5)

• Buss-Perry Aggression Questionnaire

  aggression and hostility

  From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)

• Modified Colorado Symptom Index

  emotional distress

  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

  criminal thinking

  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

  antisocial attitudes

  From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)

• CLCO-9 knowledge quiz

  treatment content

  From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)

Secondary Outcomes (6)

• Feasibility of implementation

  From patient recruitment until study ends (anticipated to be about 6 months after recruitment begins)

• Treatment fidelity

  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

  After each session for the duration of treatment offered during the study (anticipated to be about 6 months)

• Broset Violence Checklist scores

  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

  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).

Study Arms (1)

Changing Lives and Changing Outcomes-9 Group

EXPERIMENTAL

Changing Lives and Changing Outcomes-9, a brief cognitive-behavioral therapy intervention for people with mental illness involved in the legal system, will be administered in treatment groups consistent with standard programming at the state hospital. Patients will be able to participate in this group in addition to any other services at the hospital.

Behavioral: Changing Lives and Changing Outcomes-9

Interventions

Changing Lives and Changing Outcomes-9 BEHAVIORAL

A brief, cognitive therapy-based intervention for people with mental illness and legal system involvement.

Also known as: CLCO-9

Changing Lives and Changing Outcomes-9 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hospital status that does not permit group attendance (e.g., room-based seclusion)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Worcester Recovery Center and Hospital: collaborator

Study Sites (1)

Worcester Recovery Center and Hospital

Worcester, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Faith Scanlon, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faith Scanlon, PhD

CONTACT

6177242079; fscanlon@mgh.harvard.edu

Corinne Cather, PhD

CONTACT

6177266692; CCATHER@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Counseling Psychologist, Instructor of Psychology

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)