Serious Mental IllnessCLCO-9NCT07359157
Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital
A study testing Changing Lives and Changing Outcomes-9 in people with Serious Mental Illness and Psychotic Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
People with serious mental illness (depression, bipolar, and schizophrenia spectrum disorders) have high rates of repeated criminal legal involvement and psychiatric hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Mental Illness, Psychotic Disorder, Depression
- What is being tested?
- Changing Lives and Changing Outcomes-9
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hospital status that does not permit group attendance (e.g., room-based seclusion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Worcester Recovery Center and Hospital
Worcester, Massachusetts, 02451
Faith Scanlon, PhD, 6177242079, fscanlon@mgh.harvard.edu
About this study
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
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:
Read more
- Evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH
- 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
- 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.
Read the 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.
- Conditions
- Serious Mental Illness, Psychotic Disorder, Depression, Bipolar
- Being tested
- Changing Lives and Changing Outcomes-9
- Keywords
- serious mental illness, criminogenic risk, criminal legal involvement, treatment, forensic, state hospital
- Medical subject headings
- Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing Lives and Changing Outcomes-9Behavioural
Also called CLCO-9
A brief, cognitive therapy-based intervention for people with mental illness and legal system involvement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Changing Lives and Changing Outcomes-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buss-Perry Aggression Questionnaire
aggression and hostility
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
number of patients who agree to join the group and attendance
Measured: From patient recruitment until study ends (anticipated to be about 6 months after recruitment begins)
Treatment fidelity
Session fidelity to the CLCO-9 treatment program (per session fidelity checklists)
Measured: 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
Patient satisfaction
Measured: After each session for the duration of treatment offered during the study (anticipated to be about 6 months)
Broset Violence Checklist scores
Behavioral indicator documented in patient chart as a staff-rated indicator of imminent patient violence (only available if patient gives permission for chart review)
Measured: 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
Behavioral indicator documented in patient chart of instances that patient was restrained/secluded during current hospitalization (only available if patient gives permission for chart review)
Measured: 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
Behavioral indicator documented in patient chart of patient's engagement in treatment meetings and groups beyond the CLCO-9 group during the current hospitalization (only available if patient gives permission for chart review)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start5 Feb 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Worcester Recovery Center and Hospital
- Responsible party
- Principal investigator, Faith Scanlon, Massachusetts General Hospital
- Investigators
- Faith Scanlon, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359157
- Sponsor's protocol ID
- 2025P000801
- Acronym
- CLCO-9
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have a plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07359157
- Acronym / sponsor ID
- CLCO-9 / 2025P000801
- Conditions
- Serious Mental Illness, Psychotic Disorder, Depression, Bipolar
- Keywords
- serious mental illness, criminogenic risk, criminal legal involvement, treatment, forensic, state hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Worcester Recovery Center and Hospital
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate feasibility, fidelity, and patient satisfaction during the implementation of the CLCO-9 group treatment at WRCH
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Changing Lives and Changing Outcomes-9 Group | Experimental | Behavioral: Changing Lives and Changing Outcomes-9Changing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Hospital status that does not permit group attendance (e.g., room-based seclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changing Lives and Changing Outcomes-9Also: CLCO-9A brief, cognitive therapy-based intervention for people with mental illness and legal system involvement. | Behavioural | Changing Lives and Changing Outcomes-9 Group |
Primary outcome
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)
aggression and hostility
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)
emotional distress
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)
criminal thinking
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)
antisocial attitudes
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)
treatment content
6 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. We do not have a plan to share individual participant data with other researchers.
Related trials for Serious Mental Illness
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Recruiting
SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
Palliative Care, Serious Games
Not yet recruitingObservational study
Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
Severe Mental Illness, Hospitalizations Psychiatric
Recruiting
Facilitation to Increase Tobacco Treatment
Serious Mental Illness, Tobacco Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faith Scanlon, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changing Lives and Changing Outcomes-9 in people with Serious Mental Illness and Psychotic Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faith Scanlon, PhD (6177242079, fscanlon@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.