← Back to Search

Behavioral Activation for First Episode Psychosis

N/A
Recruiting
Led By Maria Santos, PhD
Research Sponsored by California State University, San Bernardino
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-intervention pam13 at post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Awards & highlights

Study Summary

This trial will compare a behavioral intervention to usual care for people with first episode psychosis, delivered over 6 months. It is expected that those receiving the intervention will show better engagement.

Who is the study for?
This trial is for Latinos aged 15-35 with a first episode of psychosis, who can speak English or Spanish. They must have a caregiver willing to participate and be able to give informed consent. Excluded are those with psychosis due to other medical conditions or substance use, serious medical issues, or more than three years since their first psychotic episode.Check my eligibility
What is being tested?
The study compares a special 12-session program called Behavioral Activation (BA) designed for new cases of psychosis against the usual mental health care over six months. Both groups will also have family sessions. The goal is to see if BA helps patients engage better in their treatment.See study design
What are the potential side effects?
Since this trial involves behavioral therapy rather than medication, there may not be traditional side effects; however, participants might experience emotional discomfort during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 35 years old.
Select...
I have been diagnosed with a type of schizophrenia or related disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-intervention pam13 at post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-intervention pam13 at post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Engagement on the Patient Activation Measure (PAM13) at 1-Month Post-Intervention
Change in Engagement on the Patient Activation Measure (PAM13) at 6-Months Post-Intervention
Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
+1 more
Secondary outcome measures
Change in Depression on the Calgary Depression Scale (CDS) at 1-Month Post-Intervention
Change in Depression on the Calgary Depression Scale (CDS) at 6-Months Post-Intervention
Change in Depression on the Calgary Depression Scale (CDS) at Post-Intervention
+18 more
Other outcome measures
Activation as measured by the Behavioral Activation Homework Completion Observer-Based Coding System (BA HC)
Alliance as measured by the Working Alliance Inventory - Short Form (WAI-SF)
Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 1-Month Post-Intervention
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation for First Episode PsychosisExperimental Treatment1 Intervention
Patients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study.
Group II: Treatment at UsualActive Control1 Intervention
Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,799 Previous Clinical Trials
2,661,106 Total Patients Enrolled
University of Southern CaliforniaOTHER
916 Previous Clinical Trials
1,605,166 Total Patients Enrolled
Olive View-UCLA Education & Research InstituteOTHER
33 Previous Clinical Trials
879,956 Total Patients Enrolled

Media Library

Behavioral Activation for First Episode Psychosis Clinical Trial Eligibility Overview. Trial Name: NCT05310838 — N/A
First Episode Psychosis Research Study Groups: Treatment at Usual, Behavioral Activation for First Episode Psychosis
First Episode Psychosis Clinical Trial 2023: Behavioral Activation for First Episode Psychosis Highlights & Side Effects. Trial Name: NCT05310838 — N/A
Behavioral Activation for First Episode Psychosis 2023 Treatment Timeline for Medical Study. Trial Name: NCT05310838 — N/A
~20 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top