Engagement, Patient, First Episode Psychosis
Conditions
Keywords
First Episode Psychosis, Behavioral Activation, Engagement, Latinx
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALTreatment As Usual
Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.
Sponsors
California State University, San Bernardino
University of Southern California
Olive View-UCLA Education & Research Institute
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.' |
| 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.' |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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. |
| 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 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaria Santos, PhD
California State University, San Bernardino
Outcome results
None listed