xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05967195</url>
    </required_header>
    <id_info>
      <org_study_id>2023-03</org_study_id>
      <nct_id>NCT05967195</nct_id>
    </id_info>
    <brief_title>Trial to Increase FEP Attendance</brief_title>
    <official_title>Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pennsylvania</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional&#xD;
        and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a&#xD;
        multidisciplinary, team-based intervention known to improve such outcomes, including suicide&#xD;
        risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot&#xD;
        study will develop and test feasibility of a behavioral change program that uses moderate&#xD;
        financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80&#xD;
        patient-participants at these two clinics will be recruited to assess feasibility and&#xD;
        acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will&#xD;
        be recruited to assess feasibility and acceptability from clinician perspectives, and 50&#xD;
        clinicians from peer clinics not involved in the intervention will be recruited to assess&#xD;
        scalability of the intervention. The trial will feature an three-month period for recruitment&#xD;
        and baseline data collection and will subsequently feature three intervention periods (3&#xD;
        months each) where modifications to the interventions will be tested (each informed by the&#xD;
        feasibility and acceptability findings of the prior period) with the aim of sequentially&#xD;
        improving it.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability of intervention measure (AIM)</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of intervention measure (AIM)</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of intervention measure (AIM)</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of intervention measure (FIM)</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of intervention measure (FIM)</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of intervention measure (FIM)</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Implementation Survey Response</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>Implementation survey. Results will be used to optimize intervention from implementation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation Survey Response</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>Implementation survey. Results will be used to optimize intervention from implementation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implementation Survey Response</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>Implementation survey. Results will be used to optimize intervention from implementation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation Survey Response</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>Motivation survey. Results will be used to optimize intervention from motivation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation Survey Response</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>Motivation survey. Results will be used to optimize intervention from motivation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivation Survey Response</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>Motivation survey. Results will be used to optimize intervention from motivation perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ethical Concern Survey Response</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ethical Concern Survey Response</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ethical Concern Survey Response</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>attrition</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>rate of attrition</description>
    </other_outcome>
    <other_outcome>
      <measure>attrition</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>rate of attrition</description>
    </other_outcome>
    <other_outcome>
      <measure>attrition</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>rate of attrition</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>psychotic symptomology</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.</description>
    </other_outcome>
    <other_outcome>
      <measure>depression</measure>
      <time_frame>Change at 1 year</time_frame>
      <description>abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)</description>
    </other_outcome>
    <other_outcome>
      <measure>depression</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)</description>
    </other_outcome>
    <other_outcome>
      <measure>depression</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)</description>
    </other_outcome>
    <other_outcome>
      <measure>quality of life</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)</description>
    </other_outcome>
    <other_outcome>
      <measure>quality of life</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)</description>
    </other_outcome>
    <other_outcome>
      <measure>quality of life</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)</description>
    </other_outcome>
    <other_outcome>
      <measure>recovery</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)</description>
    </other_outcome>
    <other_outcome>
      <measure>recovery</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)</description>
    </other_outcome>
    <other_outcome>
      <measure>recovery</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)</description>
    </other_outcome>
    <other_outcome>
      <measure>treatment motivation (intrinsic versus extrinsic)</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.</description>
    </other_outcome>
    <other_outcome>
      <measure>treatment motivation (intrinsic versus extrinsic)</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.</description>
    </other_outcome>
    <other_outcome>
      <measure>treatment motivation (intrinsic versus extrinsic)</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived coercion</measure>
      <time_frame>Change at 11 months</time_frame>
      <description>Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived coercion</measure>
      <time_frame>Change at 8 months</time_frame>
      <description>Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived coercion</measure>
      <time_frame>Change at 5 months</time_frame>
      <description>Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.</description>
    </other_outcome>
    <other_outcome>
      <measure>attendance rate</measure>
      <time_frame>Change over 1 year</time_frame>
      <description>number of appointments attended in a given period divided by number of appointments scheduled</description>
    </other_outcome>
    <other_outcome>
      <measure>attendance rate</measure>
      <time_frame>Change at 9 months</time_frame>
      <description>number of appointments attended in a given period divided by number of appointments scheduled</description>
    </other_outcome>
    <other_outcome>
      <measure>attendance rate</measure>
      <time_frame>Change at 6 months</time_frame>
      <description>number of appointments attended in a given period divided by number of appointments scheduled</description>
    </other_outcome>
    <enrollment type="Anticipated">145</enrollment>
    <condition>First-Episode Psychosis</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Financial Incentive and Text-Messages</intervention_name>
      <description>Patient-participants will receive modest financial incentive for attending therapy or medication management appointments combined with text messages to encourage attendance at these appointments. Text messages will be informed by principles of behavioral economics. Maximum incentive = $50/month if all appointments attended. Incentives will be pro-rated by percentage of appointments attended. Pro-rating strategies (e.g., uniform amount per appointment, escalating [aka, 'back-loaded'], or decreasing [aka 'frontloaded'] will be sequentially changed based on acceptability and other intervention-related data gathered from participants during the trial.&#xD;
  Clinician-participants will not receive any intervention, but will receive surveys and interviews to assess their perceptions about the optimization, acceptability, scalability, and other implementation barriers/facilitators for the intervention.</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. For all participants, age ≥ 18 years old.&#xD;
  &#xD;
            2. For intervention trial and patient feasibility and acceptability measurement: Patients&#xD;
               with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis&#xD;
               Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation&#xD;
               and Recovery Center (PERC).&#xD;
  &#xD;
            3. For clinician feasibility and acceptability measurement at intervention sites:&#xD;
               Clinicians working at PEACE and PERC where the intervention will be piloted.&#xD;
  &#xD;
            4. For clinician implementation facilitator and barrier assessment at other Connection&#xD;
               LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites&#xD;
               other than PEACE and PERC.Participants must sign the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. For intervention trial and patient feasibility and acceptability measurement:&#xD;
               Expectation of leaving coordinated specialty care programing within 6 months (which&#xD;
               will exclude all of the PI's patient panel) and/or intellectual disability of&#xD;
               sufficient degree that the patient's primary psychiatrist expects to compromise&#xD;
               capacity to consent to this research and/or psychosis secondary to another medical&#xD;
               condition (which may not share the same motivational features that are otherwise&#xD;
               understood about the primary psychiatric conditions with psychosis).&#xD;
  &#xD;
            2. For clinician feasibility and acceptability measurement at intervention sites: Study&#xD;
               investigators who work at these clinics will be excluded from participation in the&#xD;
               feasibility and acceptability study component given their role in the trial planning&#xD;
               and execution.&#xD;
  &#xD;
            3. For clinician implementation facilitator and barrier assessment at other Connection&#xD;
               LHS sites to assess for scalability: none.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Willam R Smith, MD, PhD</last_name>
      <phone>215-898-7366</phone>
      <email>wrsmith5@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>William Smith</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05967195
  org study id: 2023-03
  nct id: NCT05967195
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional
        and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a
        multidisciplinary, team-based intervention known to improve such outcomes, including suicide
        risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot
        study will develop and test feasibility of a behavioral change program that uses moderate
        financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80
        patient-participants at these two clinics will be recruited to assess feasibility and
        acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will
        be recruited to assess feasibility and acceptability from clinician perspectives, and 50
        clinicians from peer clinics not involved in the intervention will be recruited to assess
        scalability of the intervention. The trial will feature an three-month period for recruitment
        and baseline data collection and will subsequently feature three intervention periods (3
        months each) where modifications to the interventions will be tested (each informed by the
        feasibility and acceptability findings of the prior period) with the aim of sequentially
        improving it.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acceptability of intervention measure (AIM)
  time frame: Change at 11 months
  description: The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
  measure: Acceptability of intervention measure (AIM)
  time frame: Change at 8 months
  description: The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
  measure: Acceptability of intervention measure (AIM)
  time frame: Change at 5 months
  description: The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
  measure: Feasibility of intervention measure (FIM)
  time frame: Change at 11 months
  description: The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
  measure: Feasibility of intervention measure (FIM)
  time frame: Change at 8 months
  description: The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
  measure: Feasibility of intervention measure (FIM)
  time frame: Change at 5 months
  description: The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
  measure: Implementation Survey Response
  time frame: Change at 1 year
  description: Implementation survey. Results will be used to optimize intervention from implementation perspective.
  measure: Implementation Survey Response
  time frame: Change at 9 months
  description: Implementation survey. Results will be used to optimize intervention from implementation perspective.
  measure: Implementation Survey Response
  time frame: Change at 6 months
  description: Implementation survey. Results will be used to optimize intervention from implementation perspective.
  measure: Motivation Survey Response
  time frame: Change at 1 year
  description: Motivation survey. Results will be used to optimize intervention from motivation perspective.
  measure: Motivation Survey Response
  time frame: Change at 9 months
  description: Motivation survey. Results will be used to optimize intervention from motivation perspective.
  measure: Motivation Survey Response
  time frame: Change at 6 months
  description: Motivation survey. Results will be used to optimize intervention from motivation perspective.
  measure: Ethical Concern Survey Response
  time frame: Change at 1 year
  description: Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
  measure: Ethical Concern Survey Response
  time frame: Change at 9 months
  description: Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
  measure: Ethical Concern Survey Response
  time frame: Change at 6 months
  description: Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
  measure: attrition
  time frame: Change at 1 year
  description: rate of attrition
  measure: attrition
  time frame: Change at 9 months
  description: rate of attrition
  measure: attrition
  time frame: Change at 6 months
  description: rate of attrition
  measure: psychotic symptomology
  time frame: Change at 1 year
  description: Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
  measure: psychotic symptomology
  time frame: Change at 9 months
  description: Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
  measure: psychotic symptomology
  time frame: Change at 6 months
  description: Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
  measure: psychotic symptomology
  time frame: Change at 11 months
  description: modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
  measure: psychotic symptomology
  time frame: Change at 8 months
  description: modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
  measure: psychotic symptomology
  time frame: Change at 6 months
  description: modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
  measure: depression
  time frame: Change at 1 year
  description: abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
  measure: depression
  time frame: Change at 9 months
  description: abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
  measure: depression
  time frame: Change at 6 months
  description: abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
  measure: quality of life
  time frame: Change at 11 months
  description: 4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
  measure: quality of life
  time frame: Change at 8 months
  description: 4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
  measure: quality of life
  time frame: Change at 5 months
  description: 4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
  measure: recovery
  time frame: Change at 11 months
  description: 5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
  measure: recovery
  time frame: Change at 8 months
  description: 5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
  measure: recovery
  time frame: Change at 5 months
  description: 5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
  measure: treatment motivation (intrinsic versus extrinsic)
  time frame: Change at 11 months
  description: Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
  measure: treatment motivation (intrinsic versus extrinsic)
  time frame: Change at 8 months
  description: Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
  measure: treatment motivation (intrinsic versus extrinsic)
  time frame: Change at 5 months
  description: Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
  measure: Perceived coercion
  time frame: Change at 11 months
  description: Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
  measure: Perceived coercion
  time frame: Change at 8 months
  description: Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
  measure: Perceived coercion
  time frame: Change at 5 months
  description: Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
  measure: attendance rate
  time frame: Change over 1 year
  description: number of appointments attended in a given period divided by number of appointments scheduled
  measure: attendance rate
  time frame: Change at 9 months
  description: number of appointments attended in a given period divided by number of appointments scheduled
  measure: attendance rate
  time frame: Change at 6 months
  description: number of appointments attended in a given period divided by number of appointments scheduled
  intervention type: Behavioral
  intervention name: Financial Incentive and Text-Messages
  description: Patient-participants will receive modest financial incentive for attending therapy or medication management appointments combined with text messages to encourage attendance at these appointments. Text messages will be informed by principles of behavioral economics. Maximum incentive = $50/month if all appointments attended. Incentives will be pro-rated by percentage of appointments attended. Pro-rating strategies (e.g., uniform amount per appointment, escalating [aka, 'back-loaded'], or decreasing [aka 'frontloaded'] will be sequentially changed based on acceptability and other intervention-related data gathered from participants during the trial.
  Clinician-participants will not receive any intervention, but will receive surveys and interviews to assess their perceptions about the optimization, acceptability, scalability, and other implementation barriers/facilitators for the intervention.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Willam R Smith, MD, PhD
  phone: 215-898-7366
  email: wrsmith5@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: William Smith
  investigator title: Principal Investigator
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders