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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
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.
San Fernando Mental Health Center
Granada Hills, California, United States
RECRUITINGOlive View - UCLA Medical Center
Sylmar, California, United States
RECRUITINGChange 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.
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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