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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Buss-Perry Aggression Questionnaire
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Hospital status that does not permit group attendance (e.g., room-based seclusion)
研究组 & 干预措施
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.
干预措施: Changing Lives and Changing Outcomes-9 (Behavioral)
结局指标
主要结局
Buss-Perry Aggression Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From before starting treatment (baseline assessment) to after completing treatment (anticipated to be about 7 weeks after starting treatment)
treatment content
次要结局
- 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).)
- Patient engagement in other treatment meetings/groups(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).)
研究者
Faith Scanlon
Counseling Psychologist, Instructor of Psychology
Massachusetts General Hospital