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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
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I am between 15 and 35 years old.
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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
2,775 Previous Clinical Trials
2,673,743 Total Patients Enrolled
California State University, San BernardinoLead Sponsor
2 Previous Clinical Trials
4,367 Total Patients Enrolled
University of Southern CaliforniaOTHER
900 Previous Clinical Trials
1,595,565 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept participants aged 70 and above?

"This clinical trial is available to patients aged 15-35. For younger and older individuals, there are 118 trials for those under 18 years of age and 278 studies suitable for persons over the age of 65."

Answered by AI

What is the ultimate aspiration of this research project?

"This medical study seeks to measure the Engagement of participants as evaluated by the Service Engagement Scale (SES) over a period, either 6 months after start or 12 sessions. There are three secondary objectives: assessing Change in Functioning with Strauss-Carpenter level of Function Scale (Strauss-Carpenter), measuring Recovery through Maryland Assessment of Recovery in People with SMI (MARS) at 6 month Post Intervention andChange in Symptoms using Positive And Negative Syndrome Scale (PANSS)."

Answered by AI

Are there still slots open for participants in this research endeavor?

"According to information housed on clinicaltrials.gov, this medical trial is presently seeking participants and was first published in March of 2022. It underwent an update as recently as the 26th day of that same month."

Answered by AI

Are there any prerequisites for enrollment in this research project?

"This trial seeks 58 participants aged between 15 and 35, who are Latino/a and able to understand English or Spanish. They must meet the Diagnostic & Statistical Manual of Mental Disorders-5 criteria for various diagnoses in the schizophrenia spectrum like schizoaffective disorder, schizophreniform disorder, brief psychotic disorder etc., while also having a caregiver willing to give informed consent."

Answered by AI

How many participants are engaged in this clinical trial?

"Yes, according to clinicaltrials.gov the trial is currently accepting applications from patients. The original posting date was March 1st 2022 and it has recently been updated on March 26th 2022. 58 participants are required between two locations."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Fernando Mental Health Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~24 spots leftby Aug 2025