An interventional study of Behavioral Activation for First Episode Psychosis and Treatment As Usual in Engagement, Patient and First Episode Psychosis, sponsored by California State University, San Bernardino. Completed at 2 sites in United States. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by California State University, San Bernardino · Not applicable, Interventional, and Treatment
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.
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.
127 studies on the registry are indexed under Patient Participation; 64 are open to participants now.
This study's enrollment of 28 is below the median of 138 across 105 interventional studies indexed under Patient Participation.
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Exclusion Criteria:
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
Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services.
Behavioral: Treatment As Usual
Sessions will be offered weekly and dyads can complete the intervention during a 6-month period to accommodate competing demands encountered by the population.
Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.
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.'
Time frame: 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.'
Time frame: 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.'
Time frame: 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.
Time frame: Weekly per session up to 12 sessions, up to 6 months
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Change from Pre-intervention QOLI-M at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention QOLI-M at at 6-months-post-intervention
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.
Time frame: Change from Pre-intervention PANSS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Change from Pre-intervention PANSS at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention PANSS at 6-months-post-intervention
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.
Time frame: Change from Pre-intervention Strauss-Carpenter at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Change from Pre-intervention Strauss-Carpenter at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention Strauss-Carpenter at 6-months-post-intervention
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.
Time frame: Change from Pre-intervention CDS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Change from Pre-intervention CDS at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention CDS at 6-months-post-intervention
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.
Time frame: Change from Pre-intervention MARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Change from Pre-intervention MARS at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention MARS at 6-months-post-intervention
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.
Time frame: Remission at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Remission at 1-month-post-intervention
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.
Time frame: Remission at 6-months-post-intervention
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Change from Pre-intervention BADS-SF at 6-months-post-intervention
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.
Time frame: Weekly per session up to 12 sessions, up to 6 months
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.
Time frame: Change from Pre-intervention RPI at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Change from Pre-intervention RPI at 1-month-post-intervention
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.
Time frame: Change from Pre-intervention RPI at 6-months-post-intervention
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).
Time frame: Change from Pre-intervention BARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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).
Time frame: Change from Pre-intervention BARS at 1-month-post-intervention
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).
Time frame: Change from Pre-intervention BARS at 6-months-post-intervention
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.
Time frame: Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)
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.
Time frame: Weekly per session up to 12 sessions, up to 6 months
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California State University, San Bernardino