NCT05310838

Optimizing Engagement in Services for First-Episode Psychosis

Optimizing Engagement in Services for First-Episode Psychosis (FEP) in the Community Mental Health Setting

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: California State University, San Bernardino · Academic / Other
• Sex: All
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Engagement, Patient
• First Episode Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Activation for First Episode Psychosis	Sessions will be offered weekly and dyads can complete the intervention during a 6-month period to accommodate competing demands encountered by the population.
BEHAVIORAL	Treatment As Usual	Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-12-16
• Completion: 2026-06-30
• First posted: 2022-04-05
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States