Changing Lives and Changing Outcomes-9 at Worcester Recovery Center and Hospital
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently hospitalized at Worcester Recovery Center and Hospital (WRCH)
At least 18 years old
Self-reported current or past legal involvement
Speaks English
Disqualifiers
Hospital status that does not permit group attendance (e.g., room-based seclusion)
Trial design
Design model
Single group
Treatments tested in this trial
Changing Lives and Changing Outcomes-9
BehavioralA brief, cognitive therapy-based intervention for people with mental illness and legal system involvement.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Changing Lives and Changing Outcomes-9 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Buss-Perry Aggression Questionnaire
aggression and hostility
Time frame
From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)2
Modified Colorado Symptom Index
emotional distress
Time frame
From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)3
Psychological Inventory of Criminal Thinking Styles-Short Form
criminal thinking
Time frame
From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)4
Measure of Criminal Attitudes and Associates
antisocial attitudes
Time frame
From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)Secondary outcomes
1
Feasibility of implementation
number of patients who agree to join the group and attendance
Time frame
From patient recruitment until study ends (anticipated to be about 6 months after recruitment begins)2
Treatment fidelity
Session fidelity to the CLCO-9 treatment program (per session fidelity checklists)
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)3
Client Satisfaction Questionnare-8
Patient satisfaction
Time frame
After each session for the duration of treatment offered during the study (anticipated to be about 6 months)4
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)
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Worcester Recovery Center and Hospital
Collaborator
Source ClinicalTrials.gov