Optimizing Engagement in Services for First-Episode Psychosis

First Episode Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310838
• Other study ID #: IRB-FY2020-167
• Secondary ID: K23MH119313
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: March 2024
• Source: California State University, San Bernardino
• Contact: Maria Santos, PhD
• Phone: 909-537-4507
• Email: Maria.Santos[@]csusb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: February 28, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Engagement, Patient
• First Episode Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	San Fernando Mental Health Center	Granada Hills	California
United States	Olive View - UCLA Medical Center	Sylmar	California

Sponsors (4)

Lead Sponsor	Collaborator
California State University, San Bernardino	National Institute of Mental Health (NIMH), Olive View-UCLA Education & Research Institute, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at Post-Intervention	The 9-item self-report BADS-SF tracks when and how changes in activation occur (7-point scale; not at all to completely). It has shown good internal consistency reliability, construct validity, and predictive validity. BADS-SF is the primary measure of activation.	Change from Pre-intervention BADS-SF at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Other	Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 1-Month Post-Intervention	The 9-item self-report BADS-SF tracks when and how changes in activation occur (7-point scale; not at all to completely). It has shown good internal consistency reliability, construct validity, and predictive validity. BADS-SF is the primary measure of activation.	Change from Pre-intervention BADS-SF at 1-month-post-intervention
Other	Change in Activation as measured by the Behavioral Activation for Depression Scale-Short Form (BADS-SF) at 6-Months Post-Intervention	The 9-item self-report BADS-SF tracks when and how changes in activation occur (7-point scale; not at all to completely). It has shown good internal consistency reliability, construct validity, and predictive validity. BADS-SF is the primary measure of activation.	Change from Pre-intervention BADS-SF at 6-months-post-intervention
Other	Activation as measured by the Behavioral Activation Homework Completion Observer-Based Coding System (BA HC)	BA HC permits reliable coding of the characterization and completion of BA homework, including type of assignment, realm of functioning it targets, and the extent of homework completion. It will be used as a secondary measure of activation for BA.	Weekly per session up to 12 sessions, up to 6 months
Other	Change in Environmental Reward as measured by the Reward Probability Index (RPI) at Post-Intervention	RPI is a 20-item self-report measure of contact with environmental reward, which is theorized to maintain healthy behavior per behavioral models of psychopathology, with good internal consistency, test-retest reliability, and discriminant, predictive, and convergent validity. Items are rated on a 4-point Likert scale with higher scores indicating higher levels of reinforcement.	Change from Pre-intervention RPI at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Other	Change in Environmental Reward as measured by the Reward Probability Index (RPI) at 1-Month Post-Intervention	RPI is a 20-item self-report measure of contact with environmental reward, which is theorized to maintain healthy behavior per behavioral models of psychopathology, with good internal consistency, test-retest reliability, and discriminant, predictive, and convergent validity. Items are rated on a 4-point Likert scale with higher scores indicating higher levels of reinforcement.	Change from Pre-intervention RPI at 1-month-post-intervention
Other	Change in Environmental Reward as measured by the Reward Probability Index (RPI) at 6-Months Post-Intervention	RPI is a 20-item self-report measure of contact with environmental reward, which is theorized to maintain healthy behavior per behavioral models of psychopathology, with good internal consistency, test-retest reliability, and discriminant, predictive, and convergent validity. Items are rated on a 4-point Likert scale with higher scores indicating higher levels of reinforcement.	Change from Pre-intervention RPI at 6-months-post-intervention
Other	Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at Post-Intervention	The 4-item BARS is a brief, clinician-administered instrument to assess oral antipsychotic medication adherence and has good sensitivity (73%) and specificity (74%) in identifying non-adherent outpatients (defined as <70% mean electronic monitoring adherence).	Change from Pre-intervention BARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Other	Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at 1-Month Post-Intervention	The 4-item BARS is a brief, clinician-administered instrument to assess oral antipsychotic medication adherence and has good sensitivity (73%) and specificity (74%) in identifying non-adherent outpatients (defined as <70% mean electronic monitoring adherence).	Change from Pre-intervention BARS at 1-month-post-intervention
Other	Change in medication adherence as measured by the Brief Adherence Rating Scale (BARS) at 6-Months Post-Intervention	The 4-item BARS is a brief, clinician-administered instrument to assess oral antipsychotic medication adherence and has good sensitivity (73%) and specificity (74%) in identifying non-adherent outpatients (defined as <70% mean electronic monitoring adherence).	Change from Pre-intervention BARS at 6-months-post-intervention
Other	Alliance as measured by the Working Alliance Inventory - Short Form (WAI-SF)	The 12-item WAI-SF measures agreement on goals and tasks of therapy and the bond between the therapist and the client and has demonstrated good reliability and convergent validity. Items are rated on a 5-point Likert scale with higher scores indicating a better therapeutic alliance. The WAI-SF will be used to assess the patient-provider alliance.	Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Other	Person-centered care as measured by the Combined Assessment of Psychiatric Environments (CAPE)	CAPE assesses patient perspective patient-centered care and shows internal consistency reliability, test-retest reliability, and construct and criterion validity.	Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Other	Family involvement	Family involvement, or whether a family member was present at a service encounter, will be assessed by an independent observer based on review of service. This method has been used in prior early intervention studies.	Weekly per session up to 12 sessions, up to 6 months
Primary	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)
Primary	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
Primary	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
Primary	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	Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at Post-Intervention	The QLS is a 21-item, clinician-administered, semi-structured interview on a 7-point scale with higher scores reflecting normal or unimpaired functioning. It has shown high sensitivity to change and treatment effect. The total score is the main secondary outcome of interest.	Change from Pre-intervention QLS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 1-Month Post-Intervention	The QLS is a 21-item, clinician-administered, semi-structured interview on a 7-point scale with higher scores reflecting normal or unimpaired functioning. It has shown high sensitivity to change and treatment effect. The total score is the main secondary outcome of interest.	Change from Pre-intervention QLS at 1-month-post-intervention
Secondary	Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 6-Months Post-Intervention	The QLS is a 21-item, clinician-administered, semi-structured interview on a 7-point scale with higher scores reflecting normal or unimpaired functioning. It has shown high sensitivity to change and treatment effect. The total score is the main secondary outcome of interest.	Change from Pre-intervention QLS at 6-months-post-intervention
Secondary	Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at Post-Intervention	The QOLI-M has well established psychometric properties with individuals with serious mental illness (SMI) and will be used to derive overall subjective quality of life and objective and subjective quality of social and family interaction ratings. The QOLI-M, not the QLS, assesses general quality of life which focuses on areas beyond those affected by psychotic illness.	Change from Pre-intervention QOLI-M at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 1-Month Post-Intervention	The QOLI-M has well established psychometric properties with individuals with serious mental illness (SMI) and will be used to derive overall subjective quality of life and objective and subjective quality of social and family interaction ratings. The QOLI-M, not the QLS, assesses general quality of life which focuses on areas beyond those affected by psychotic illness.	Change from Pre-intervention QOLI-M at 1-month-post-intervention
Secondary	Change in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 6-Months Post-Intervention	The QOLI-M has well established psychometric properties with individuals with serious mental illness (SMI) and will be used to derive overall subjective quality of life and objective and subjective quality of social and family interaction ratings. The QOLI-M, not the QLS, assesses general quality of life which focuses on areas beyond those affected by psychotic illness.	Change from Pre-intervention QOLI-M at at 6-months-post-intervention
Secondary	Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at Post-Intervention	This 30-item widely-used clinician-administered instrument measures psychosis symptom severity and remission. Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Change from Pre-intervention PANSS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 1-Month Post-Intervention	This 30-item widely-used clinician-administered instrument measures psychosis symptom severity and remission. Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Change from Pre-intervention PANSS at 1-month-post-intervention
Secondary	Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 6-Months Post-Intervention	This 30-item widely-used clinician-administered instrument measures psychosis symptom severity and remission. Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Change from Pre-intervention PANSS at 6-months-post-intervention
Secondary	Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at Post-Intervention	The Strauss-Carpenter is a semi-structured interviewer-administered scale that assesses functioning in social contacts, work, symptomatology, and function. Items are rated on a five-point scale (0-4) with higher scores reflecting better functioning.	Change from Pre-intervention Strauss-Carpenter at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 1-Month Post-Intervention	The Strauss-Carpenter is a semi-structured interviewer-administered scale that assesses functioning in social contacts, work, symptomatology, and function. Items are rated on a five-point scale (0-4) with higher scores reflecting better functioning.	Change from Pre-intervention Strauss-Carpenter at 1-month-post-intervention
Secondary	Change in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 6-Months Post-Intervention	The Strauss-Carpenter is a semi-structured interviewer-administered scale that assesses functioning in social contacts, work, symptomatology, and function. Items are rated on a five-point scale (0-4) with higher scores reflecting better functioning.	Change from Pre-intervention Strauss-Carpenter at 6-months-post-intervention
Secondary	Change in Depression on the Calgary Depression Scale (CDS) at Post-Intervention	The CDS is an interview-based 9-item scale that measures depression severity in people with schizophrenia and is valid and reliable. Items are rated on a four-point scale with higher scores reflecting greater severity of symptoms.	Change from Pre-intervention CDS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Depression on the Calgary Depression Scale (CDS) at 1-Month Post-Intervention	The CDS is an interview-based 9-item scale that measures depression severity in people with schizophrenia and is valid and reliable. Items are rated on a four-point scale with higher scores reflecting greater severity of symptoms.	Change from Pre-intervention CDS at 1-month-post-intervention
Secondary	Change in Depression on the Calgary Depression Scale (CDS) at 6-Months Post-Intervention	The CDS is an interview-based 9-item scale that measures depression severity in people with schizophrenia and is valid and reliable. Items are rated on a four-point scale with higher scores reflecting greater severity of symptoms.	Change from Pre-intervention CDS at 6-months-post-intervention
Secondary	Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at Post-Intervention	The 25-item patient-report MARS measures recovery and has excellent internal consistency and test-retest reliability and good face and content validity. Items are rated on a five-point scale with higher scores reflecting greater self-reported recovery.	Change from Pre-intervention MARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 1-Month Post-Intervention	The 25-item patient-report MARS measures recovery and has excellent internal consistency and test-retest reliability and good face and content validity. Items are rated on a five-point scale with higher scores reflecting greater self-reported recovery.	Change from Pre-intervention MARS at 1-month-post-intervention
Secondary	Change in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 6-Months Post-Intervention	The 25-item patient-report MARS measures recovery and has excellent internal consistency and test-retest reliability and good face and content validity. Items are rated on a five-point scale with higher scores reflecting greater self-reported recovery.	Change from Pre-intervention MARS at 6-months-post-intervention
Secondary	PANSS-based Remission Rates at Post-Intervention	Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Remission at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
Secondary	PANSS-based Remission Rates at 1-Month Post-Intervention	Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Remission at 1-month-post-intervention
Secondary	PANSS-based Remission Rates at 6-Months Post-Intervention	Scores 4 = on delusions, conceptual disorganization, hallucinatory behavior, mannerisms & posturing, and unusual thought content will be considered in remission.	Remission at 6-months-post-intervention