Optimizing Engagement in Services for First-Episode Psychosis (FEP) in the Community Mental Health Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
研究概览
简要总结
This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.
详细描述
After an initial pre-screen, screening, and pre-intervention assessment, enrolled participants will be randomized to either BA or TAU. The study intervention phase will last up to 6 months, during which time BA participants will receive up to 12 one-on-one BA sessions and TAU participants will receive the usual care (e.g., medication management and any other service [e.g., group counseling]). Participants will be assessed at post-intervention, 1-month-post-intervention, and 6-month-post-intervention. The primary objective of aim 1 is to examine whether BA for FEP improves engagement in services better than TAU among Latinos with FEP and their families. Secondary objectives of aim 1 are to examine whether BA participants show greater improvements in quality of life, symptoms (e.g., psychosis, depression), functioning, and recovery compared to TAU participants, and whether BA participants have greater remission rates than the TAU group at 1- and 6-month post-intervention. Additionally, the association between potential BA mediators and engagement will be examined to identify mechanisms of engagement. Potential predictors of engagement will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identification as Latino
- •Age 15 to 35
- •Diagnostic & Statistical Manual of Mental Disorders-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, other specified schizophrenia spectrum, affective psychosis, and other psychotic disorder criteria
- •Ability to speak English or Spanish
- •Caregiver willing to consent to participate in the study and care
- •Ability to provide fully informed consent
排除标准
- •Diagnosis of psychotic disorder due to another medical condition or substance/medication-induced psychotic disorder
- •Presence of a serious medical condition
- •3≤ years after the onset
研究组 & 干预措施
Behavioral Activation for First Episode Psychosis
Patients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study.
干预措施: Behavioral Activation for First Episode Psychosis (Behavioral)
Treatment at Usual
Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services.
干预措施: Treatment As Usual (Behavioral)
结局指标
主要结局
Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
时间窗: Change from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
PAM13 is a 13-item self-report short form of a patient's engagement in the care process at four stages. PAM13 shows high reliability that is stable across chronic illnesses and high construct validity, and measures change over time. Items are rated on a 4-point Likert scale (totally disagree to totally agree) with higher scores reflecting higher activation; respondent may select 'not applicable.'
Engagement as measured by the Service Engagement Scale (SES)
时间窗: Weekly per session up to 12 sessions, up to 6 months
The 14-item provider rated SES has demonstrated good reliability and validity and reflects client availability, collaboration, help-seeking, and adherence. Items are rated on a 4-point Likert scale with higher scores reflecting clients' greater levels of difficulty engaging with services. The SES is a secondary measure of service engagement.
Change in Engagement on the Patient Activation Measure (PAM13) at 1-Month Post-Intervention
时间窗: Change from Pre-intervention PAM13 at 1-month-post-intervention
PAM13 is a 13-item self-report short form of a patient's engagement in the care process at four stages. PAM13 shows high reliability that is stable across chronic illnesses and high construct validity, and measures change over time. Items are rated on a 4-point Likert scale (totally disagree to totally agree) with higher scores reflecting higher activation; respondent may select 'not applicable.'
Change in Engagement on the Patient Activation Measure (PAM13) at 6-Months Post-Intervention
时间窗: Change from Pre-intervention PAM13 at 6-months-post-intervention
PAM13 is a 13-item self-report short form of a patient's engagement in the care process at four stages. PAM13 shows high reliability that is stable across chronic illnesses and high construct validity, and measures change over time. Items are rated on a 4-point Likert scale (totally disagree to totally agree) with higher scores reflecting higher activation; respondent may select 'not applicable.'
次要结局
- Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at Post-Intervention(Change from Pre-intervention Strauss-Carpenter at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at Post-Intervention(Change from Pre-intervention QLS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 6-Months Post-Intervention(Change from Pre-intervention QLS at 6-months-post-intervention)
- Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at Post-Intervention(Change from Pre-intervention QOLI-M at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 1-Month Post-Intervention(Change from Pre-intervention MARS at 1-month-post-intervention)
- Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 6-Months Post-Intervention(Change from Pre-intervention QOLI-M at at 6-months-post-intervention)
- Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 6-Months Post-Intervention(Change from Pre-intervention MARS at 6-months-post-intervention)
- Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 6-Months Post-Intervention(Change from Pre-intervention PANSS at 6-months-post-intervention)
- Change in Depression on the Calgary Depression Scale (CDS) at 1-Month Post-Intervention(Change from Pre-intervention CDS at 1-month-post-intervention)
- Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at Post-Intervention(Change from Pre-intervention MARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- PANSS-based Remission Rates at 1-Month Post-Intervention(Remission at 1-month-post-intervention)
- PANSS-based Remission Rates at 6-Months Post-Intervention(Remission at 6-months-post-intervention)
- Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 1-Month Post-Intervention(Change from Pre-intervention QLS at 1-month-post-intervention)
- Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 1-Month Post-Intervention(Change from Pre-intervention QOLI-M at 1-month-post-intervention)
- Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 1-Month Post-Intervention(Change from Pre-intervention Strauss-Carpenter at 1-month-post-intervention)
- Change in Depression on the Calgary Depression Scale (CDS) at Post-Intervention(Change from Pre-intervention CDS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- PANSS-based Remission Rates at Post-Intervention(Remission at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at Post-Intervention(Change from Pre-intervention PANSS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first))
- Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 1-Month Post-Intervention(Change from Pre-intervention PANSS at 1-month-post-intervention)
- Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 6-Months Post-Intervention(Change from Pre-intervention Strauss-Carpenter at 6-months-post-intervention)
- Change in Depression on the Calgary Depression Scale (CDS) at 6-Months Post-Intervention(Change from Pre-intervention CDS at 6-months-post-intervention)
研究者
Maria Santos
Assistant Professor
California State University, San Bernardino