Recruiting

CLCO-9

Sponsor:

Massachusetts General Hospital

Code:

NCT07359157

Conditions

Serious Mental Illness

Psychotic Disorder

Depression

Bipolar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Changing Lives and Changing Outcomes-9

Study Details

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. 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.

Conditions

Serious Mental Illness

Psychotic Disorder

Depression

Bipolar

Study ID

NCT07359157

Start date

Feb 5, 2026

Status verified date

Feb, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Changing Lives and Changing Outcomes-9 Group

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.

Interventions

Changing Lives and Changing Outcomes-9

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Faith Scanlon, PhD

6177242079fscanlon@mgh.harvard.edu

Corinne Cather, PhD

6177266692CCATHER@mgh.harvard.edu

Locations

Worcester Recovery Center and Hospital

Recruiting

Worcester, Massachusetts, United States, 02451

Contacts

Faith Scanlon, PhD

6177242079fscanlon@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 12, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-12.