Trial to Increase FEP Attendance

May 6, 2026 updated by: William Smith, University of Pennsylvania

Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27608
        • University of North Carolina at Chapel Hill (ENCOMPASS Program)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19123
        • PEACE Program, Horizon House, Inc.
      • Philadephia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. For all participants, age ≥ 18 years old.
  2. For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
  3. For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
  4. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form

Exclusion Criteria:

  1. For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
  2. For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
  3. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of intervention measure (AIM)
Time Frame: Change at 8 months
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.
Change at 8 months
Feasibility of intervention measure (FIM)
Time Frame: Change at 8 months
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.
Change at 8 months
Acceptability of intervention measure (AIM)
Time Frame: Change at 6 months
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.
Change at 6 months
Acceptability of intervention measure (AIM)
Time Frame: Change at 4 months
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.
Change at 4 months
Feasibility of intervention measure (FIM)
Time Frame: Change at 6 months
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.
Change at 6 months
Feasibility of intervention measure (FIM)
Time Frame: Change at 4 months
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.
Change at 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implementation Survey Response
Time Frame: Change at 6 months
Implementation survey. Results will be used to optimize intervention from implementation perspective.
Change at 6 months
Motivation Survey Response
Time Frame: Change at 6 months
Motivation survey. Results will be used to optimize intervention from motivation perspective.
Change at 6 months
Ethical Concern Survey Response
Time Frame: Change at 6 months
Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
Change at 6 months
Implementation Survey Response
Time Frame: Change at 8 months
Implementation survey. Results will be used to optimize intervention from implementation perspective.
Change at 8 months
Implementation Survey Response
Time Frame: Change at 4 months
Implementation survey. Results will be used to optimize intervention from implementation perspective.
Change at 4 months
Motivation Survey Response
Time Frame: Change at 8 months
Motivation survey. Results will be used to optimize intervention from motivation perspective.
Change at 8 months
Motivation Survey Response
Time Frame: Change at 4 months
Motivation survey. Results will be used to optimize intervention from motivation perspective.
Change at 4 months
Ethical Concern Survey Response
Time Frame: Change at 8 months
Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
Change at 8 months
Ethical Concern Survey Response
Time Frame: Change at 4 months
Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
Change at 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
attrition
Time Frame: Change at 6 months
rate of attrition
Change at 6 months
psychotic symptomology
Time Frame: Change at 6 months
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.
Change at 6 months
psychotic symptomology
Time Frame: Change at 8 months
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.
Change at 8 months
psychotic symptomology
Time Frame: Change at 6 months
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.
Change at 6 months
depression
Time Frame: Change at 6 months
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)
Change at 6 months
quality of life
Time Frame: Change at 8 months
4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
Change at 8 months
recovery
Time Frame: Change at 8 months
5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
Change at 8 months
treatment motivation (intrinsic versus extrinsic)
Time Frame: Change at 8 months
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.
Change at 8 months
Perceived coercion
Time Frame: Change at 8 months
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.
Change at 8 months
attendance rate
Time Frame: Change at 6 months
number of appointments attended in a given period divided by number of appointments scheduled
Change at 6 months
attrition
Time Frame: Change at 8 months
rate of attrition
Change at 8 months
attrition
Time Frame: Change at 4 months
rate of attrition
Change at 4 months
psychotic symptomology
Time Frame: Change at 8 months
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.
Change at 8 months
psychotic symptomology
Time Frame: Change at 4 months
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.
Change at 4 months
psychotic symptomology
Time Frame: Change at 4 months
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.
Change at 4 months
depression
Time Frame: Change at 8 months
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)
Change at 8 months
depression
Time Frame: Change at 4 months
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)
Change at 4 months
quality of life
Time Frame: Change at 6 months
4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
Change at 6 months
quality of life
Time Frame: Change at 4 months
4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
Change at 4 months
recovery
Time Frame: Change at 6 months
5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
Change at 6 months
recovery
Time Frame: Change at 4 months
5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
Change at 4 months
treatment motivation (intrinsic versus extrinsic)
Time Frame: Change at 6 months
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.
Change at 6 months
treatment motivation (intrinsic versus extrinsic)
Time Frame: Change at 4 months
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.
Change at 4 months
Perceived coercion
Time Frame: Change at 6 months
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.
Change at 6 months
Perceived coercion
Time Frame: Change at 4 months
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.
Change at 4 months
attendance rate
Time Frame: Change over 8 months
number of appointments attended in a given period divided by number of appointments scheduled
Change over 8 months
attendance rate
Time Frame: Change at 4 months
number of appointments attended in a given period divided by number of appointments scheduled
Change at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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