Optimizing Engagement in Services for First-Episode Psychosis

NCT05310838 | Active Not Recruiting

• 2 other identifiers: IRB-FY2020-167K23MH119313
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Engagement, Patient; First Episode Psychosis

Keywords

First Episode Psychosis; Behavioral Activation; Engagement; Latinx

Outcome Measures

Primary Outcomes (4)

• Change in Engagement on the Patient Activation Measure (PAM13) at 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 from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)

• Change in Engagement on the Patient Activation Measure (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 from Pre-intervention PAM13 at 1-month-post-intervention

• Change in Engagement on the Patient Activation Measure (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.'

  Change from Pre-intervention PAM13 at 6-months-post-intervention

• Engagement as measured by the Service Engagement Scale (SES)

  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.

  Weekly per session up to 12 sessions, up to 6 months

Secondary Outcomes (21)

• 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 1-Month Post-Intervention

  Change from Pre-intervention QLS at 1-month-post-intervention

• 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 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

Other Outcomes (13)

• Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at Post-Intervention

  Change from Pre-intervention BADS-SF at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)

• Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 1-Month Post-Intervention

  Change from Pre-intervention BADS-SF at 1-month-post-intervention

• Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 6-Months Post-Intervention

  Change from Pre-intervention BADS-SF at 6-months-post-intervention

Study Arms (2)

Behavioral Activation for First Episode Psychosis

EXPERIMENTAL

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

Behavioral: Behavioral Activation for First Episode Psychosis

Treatment at Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment As Usual

Interventions

Behavioral Activation for First Episode Psychosis BEHAVIORAL

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 Activation for First Episode Psychosis

Treatment As Usual BEHAVIORAL

Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.

Treatment at Usual

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of psychotic disorder due to another medical condition or substance/medication-induced psychotic disorder
• Presence of a serious medical condition
• ≤ years after the onset

Sponsors & Collaborators

• California State University, San Bernardino: lead
• University of Southern California: collaborator
• Olive View-UCLA Education & Research Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

San Fernando Mental Health Center

Granada Hills, California, 91344, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Patient Participation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maria Santos, PhD

  California State University, San Bernardino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: April 5, 2022
• Study Start: March 1, 2022
• Primary Completion: December 16, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)