Engagement, PatientNCT05310838
Optimizing Engagement in Services for First-Episode Psychosis
A study testing Behavioral Activation for First Episode Psychosis and Treatment As Usual in people with Engagement, Patient and First Episode Psychosis, run by California State University, San Bernardino at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Engagement, Patient, First Episode Psychosis
- What is being tested?
- Behavioral Activation for First Episode Psychosis and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2022to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Fernando Mental Health Center
Granada Hills, California, 91344
Olive View - UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: Optimizing Engagement in Services for First-Episode Psychosis (FEP) in the Community Mental Health Setting
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.
Read the 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.
- Conditions
- Engagement, Patient, First Episode Psychosis
- Being tested
- Behavioral Activation for First Episode Psychosis, Treatment As Usual
- Keywords
- First Episode Psychosis, Behavioral Activation, Engagement, Latinx
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation for First Episode PsychosisBehavioural
Sessions will be offered weekly and dyads can complete the intervention during a 6-month period to accommodate competing demands encountered by the population.
Treatment As UsualBehavioural
Given this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation for First Episode Psychosis | Experimental | Patients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study. Receives: Behavioral: Behavioral Activation for First Episode Psychosis |
| Treatment at Usual | Active comparator | Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: 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.'
Measured: 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.'
Measured: 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.
Measured: Weekly per session up to 12 sessions, up to 6 months
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Remission at 6-months-post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Mar 2022
- Primary completion16 Dec 2025
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Engagement, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, San Bernardino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Olive View-UCLA Education & Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Maria Santos, California State University, San Bernardino
- Investigators
- Maria Santos, PhD, Principal investigator, California State University, San Bernardino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310838
- Sponsor's protocol ID
- IRB-FY2020-167
- Other IDs
- K23MH119313
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Engagement in Services for First-Episode Psychosis (FEP) in the Community Mental Health Setting
- ClinicalTrials.gov ID
- NCT05310838
- Acronym / sponsor ID
- IRB-FY2020-167
- Conditions
- Engagement, Patient, First Episode Psychosis
- Keywords
- First Episode Psychosis, Behavioral Activation, Engagement, Latinx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- California State University, San BernardinoUniversity, hospital or other
- Collaborators
- University of Southern California, Olive View-UCLA Education & Research Institute, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation for First Episode Psychosis | Experimental | Behavioral: Behavioral Activation for First Episode PsychosisPatients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study. |
| Treatment at Usual | Active comparator | Behavioral: Treatment As UsualPatients randomized to TAU will receive typical clinic care offered beyond psychiatric services. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation for First Episode PsychosisSessions will be offered weekly and dyads can complete the intervention during a 6-month period to accommodate competing demands encountered by the population. | Behavioural | Behavioral Activation for First Episode Psychosis |
| Treatment As UsualGiven this condition, patients may also receive individual rehabilitation and/or group psychosocial interventions as part of typical clinic care. | Behavioural | Treatment at Usual |
Primary outcome
Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
21 secondary outcomes
Change in Quality of Life on the Heinrichs-Carpenter Quality of Life Scale (QLS) at Post-Intervention
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Change from Pre-intervention MARS at 6-months-post-intervention
PANSS-based Remission Rates at Post-Intervention
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
Time frame: Remission at 1-month-post-intervention
PANSS-based Remission Rates at 6-Months Post-Intervention
Time frame: Remission at 6-months-post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Santos, PhD principal investigator
California State University, San Bernardino
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation for First Episode Psychosis and Treatment As Usual in people with Engagement, Patient and First Episode Psychosis, run by California State University, San Bernardino at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Engagement on the Patient Activation Measure (PAM13) at Post-Intervention (time frame: Change from Pre-intervention PAM13 at Post-intervention (after 12th session or 6-months after start of intervention, whichever comes first)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.