Optimizing Engagement in Services for First-Episode Psychosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Engagement, Patient, First Episode Psychosis

Intervention / Treatment
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* Behavioral: Behavioral Activation for First Episode Psychosis
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation for First Episode Psychosis<br>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<br>* Sessions will be offered weekly and dyads can complete the intervention during a 6-month period to accommodate competing demands encountered by the population.<br>|
| Active Comparator: Treatment at Usual<br>Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services. | Behavioral: Treatment As Usual<br>* Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First Episode Psychosis, Behavioral Activation, Engagement, Latinx