Optimizing Engagement in Services for First-Episode Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cognitive Behavioral Therapy for Patients With an Early Psychosis

NCT01511406

Psychosis Schizophrenia Depressive Symptoms +1 more

COMPLETED PHASE2

Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders

NCT02097563

Mood Disorders Psychotic Disorders

COMPLETED PHASE2

Getting Out of the House: Using Behavioral Activation to Increase Community Participation

NCT06336616

Major Depressive Disorder Schizo Affective Disorder Schizophrenia +1 more

RECRUITING NA

Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial

NCT05728138

Self Harm, First Episode Psychosis

RECRUITING NA

Outcomes From Remediation and Behavioural Intervention Techniques

NCT05731414

Schizophrenia Psychosis Psychotic Disorders +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Engagement, Patient First Episode Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Behavioral Activation for First Episode Psychosis

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

Group Type EXPERIMENTAL

Behavioral Activation for First Episode Psychosis

Intervention Type 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.

Treatment at Usual

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

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Treatment As Usual

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No