Optimizing Engagement in Services for First-Episode Psychosis

California State University, San Bernardino

Status: Enrolling

Conditions: Engagement, Patient; First Episode Psychosis

Treatments: Behavioral: Treatment As Usual; Behavioral: Behavioral Activation for First Episode Psychosis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05310838

IRB-FY2020-167

K23MH119313 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

Behavioral Activation for First Episode Psychosis

Experimental group

Description:

Patients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study.

Treatment:

Behavioral: Behavioral Activation for First Episode Psychosis

Treatment at Usual

Active Comparator group

Description:

Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services.

Treatment:

Behavioral: Treatment As Usual