Optimizing Engagement in Services for First-Episode Psychosis
- Conditions
- Engagement, PatientFirst Episode Psychosis
- Interventions
- Behavioral: Treatment As UsualBehavioral: Behavioral Activation for First Episode Psychosis
- Registration Number
- NCT05310838
- Lead Sponsor
- California State University, San Bernardino
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment at Usual Treatment As Usual Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services. Behavioral Activation for First Episode Psychosis 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.
- Primary Outcome Measures
Name Time Method Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention Change from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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.'
Engagement as measured by the Service Engagement Scale (SES) Weekly per session up to 12 sessions, up to 6 months 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.
Change in Engagement on the Patient Activation Measure (PAM13) at 1-Month Post-Intervention Change from Pre-intervention 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 in Engagement on the Patient Activation Measure (PAM13) at 6-Months Post-Intervention Change from Pre-intervention 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.'
- Secondary Outcome Measures
Name Time Method Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at Post-Intervention Change from Pre-intervention QLS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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 in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 6-Months Post-Intervention Change from Pre-intervention 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 in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at Post-Intervention Change from Pre-intervention QOLI-M at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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 in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at Post-Intervention Change from Pre-intervention Strauss-Carpenter at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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 in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 1-Month Post-Intervention Change from Pre-intervention 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 in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 6-Months Post-Intervention Change from Pre-intervention QOLI-M at 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 in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at 6-Months Post-Intervention Change from Pre-intervention 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 in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 6-Months Post-Intervention Change from Pre-intervention 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 in Depression on the Calgary Depression Scale (CDS) at 1-Month Post-Intervention Change from Pre-intervention 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 in Recovery as measured by the Maryland Assessment of Recovery in People with SMI (MARS) at Post-Intervention Change from Pre-intervention MARS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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.
PANSS-based Remission Rates at 1-Month Post-Intervention Remission at 1-month-post-intervention Scores 4 ≤ on delusions, conceptual disorganization, hallucinatory behavior, mannerisms \& posturing, and unusual thought content will be considered in remission.
PANSS-based Remission Rates at 6-Months Post-Intervention Remission at 6-months-post-intervention Scores 4 ≤ on delusions, conceptual disorganization, hallucinatory behavior, mannerisms \& posturing, and unusual thought content will be considered in remission.
Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at 1-Month Post-Intervention Change from Pre-intervention 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 in Quality of Life on the Modified Lehman Quality of Life Inventory (QOLI-M) at 1-Month Post-Intervention Change from Pre-intervention 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 in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 1-Month Post-Intervention Change from Pre-intervention 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 in Depression on the Calgary Depression Scale (CDS) at Post-Intervention Change from Pre-intervention CDS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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.
PANSS-based Remission Rates at Post-Intervention Remission at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) Scores 4 ≤ on delusions, conceptual disorganization, hallucinatory behavior, mannerisms \& posturing, and unusual thought content will be considered in remission.
Change in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at Post-Intervention Change from Pre-intervention PANSS at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first) 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 in Symptoms on the Positive And Negative Syndrome Scale (PANSS) at 1-Month Post-Intervention Change from Pre-intervention 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 in Functioning on the Strauss-Carpenter level of Function Scale (Strauss-Carpenter) at 6-Months Post-Intervention Change from Pre-intervention 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 in Depression on the Calgary Depression Scale (CDS) at 6-Months Post-Intervention Change from Pre-intervention 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.
Trial Locations
- Locations (2)
Olive View - UCLA Medical Center
🇺🇸Sylmar, California, United States
San Fernando Mental Health Center
🇺🇸Granada Hills, California, United States