Clinical trial NCT05310838: Optimizing Engagement in Services for First-Episode Psychosis
Official title: Optimizing Engagement in Services for First-Episode Psychosis (FEP) in the Community Mental Health Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Engagement, Patient
First Episode Psychosis
Keywords: First Episode Psychosis
Behavioral Activation
Engagement
Latinx
Lead sponsor: California State University, San Bernardino
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Olive View-UCLA Education & Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2022-04-05
Enrollment: 58
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
timeFrame: Change from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Engagement on the Patient Activation Measure (PAM13) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention PAM13 at 1-month-post-intervention
measure: Change in Engagement on the Patient Activation Measure (PAM13) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention PAM13 at 6-months-post-intervention
measure: Engagement as measured by the Service Engagement Scale (SES)
timeFrame: Weekly per session up to 12 sessions, up to 6 months
Secondary outcomes:
measure: Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at Post-Intervention
timeFrame: Change from Pre-intervention QLS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention QLS at 1-month-post-intervention
measure: Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention QLS at 6-months-post-intervention
measure: Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at Post-Intervention
timeFrame: Change from Pre-intervention QOLI-M at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention QOLI-M at 1-month-post-intervention
measure: Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention QOLI-M at at 6-months-post-intervention
measure: Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at Post-Intervention
timeFrame: Change from Pre-intervention PANSS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention PANSS at 1-month-post-intervention
measure: Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention PANSS at 6-months-post-intervention
measure: Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at Post-Intervention
timeFrame: Change from Pre-intervention Strauss-Carpenter at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention Strauss-Carpenter at 1-month-post-intervention
measure: Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention Strauss-Carpenter at 6-months-post-intervention
measure: Change in Depression on the Calgary Depression Scale (CDS) at Post-Intervention
timeFrame: Change from Pre-intervention CDS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Depression on the Calgary Depression Scale (CDS) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention CDS at 1-month-post-intervention
measure: Change in Depression on the Calgary Depression Scale (CDS) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention CDS at 6-months-post-intervention
measure: Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at Post-Intervention
timeFrame: Change from Pre-intervention MARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention MARS at 1-month-post-intervention
measure: Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention MARS at 6-months-post-intervention
measure: PANSS-based Remission Rates at Post-Intervention
timeFrame: Remission at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: PANSS-based Remission Rates at 1-Month Post-Intervention
timeFrame: Remission at 1-month-post-intervention
measure: PANSS-based Remission Rates at 6-Months Post-Intervention
timeFrame: Remission at 6-months-post-intervention
Other outcomes:
measure: Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at Post-Intervention
timeFrame: Change from Pre-intervention BADS-SF at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention BADS-SF at 1-month-post-intervention
measure: Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention BADS-SF at 6-months-post-intervention
measure: Activation as measured by the Behavioral Activation Homework Completion Observer-Based Coding System (BA HC)
timeFrame: Weekly per session up to 12 sessions, up to 6 months
measure: Change in Environmental Reward as measured by the Reward Probability Index (RPI) at Post-Intervention
timeFrame: Change from Pre-intervention RPI at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in Environmental Reward as measured by the Reward Probability Index (RPI) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention RPI at 1-month-post-intervention
measure: Change in Environmental Reward as measured by the Reward Probability Index (RPI) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention RPI at 6-months-post-intervention
measure: Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at Post-Intervention
timeFrame: Change from Pre-intervention BARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at 1-Month Post-Intervention
timeFrame: Change from Pre-intervention BARS at 1-month-post-intervention
measure: Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at 6-Months Post-Intervention
timeFrame: Change from Pre-intervention BARS at 6-months-post-intervention
measure: Alliance as measured by the Working Alliance Inventory - Short Form (WAI-SF)
timeFrame: Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Person-centered care as measured by the Combined Assessment of Psychiatric Environments (CAPE)
timeFrame: Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
measure: Family involvement
timeFrame: Weekly per session up to 12 sessions, up to 6 months
Locations:
city: Granada Hills
country: United States
facility: San Fernando Mental Health Center
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
Study officials:
affiliation: California State University, San Bernardino
name: Maria Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: