- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05967195
Trial to Increase FEP Attendance
March 25, 2024 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
145
Phase
- 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
- Name: Willam R Smith, MD, PhD
- Phone Number: 215-898-7366
- Email: wrsmith5@gmail.com
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- For all participants, age ≥ 18 years old.
- 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).
- For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
- 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:
- 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).
- 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.
- 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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of intervention measure (AIM)
Time Frame: Change at 11 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 11 months
|
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
|
Acceptability of intervention measure (AIM)
Time Frame: Change at 5 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 5 months
|
Feasibility of intervention measure (FIM)
Time Frame: Change at 11 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 11 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
|
Feasibility of intervention measure (FIM)
Time Frame: Change at 5 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 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation Survey Response
Time Frame: Change at 1 year
|
Implementation survey.
Results will be used to optimize intervention from implementation perspective.
|
Change at 1 year
|
Implementation Survey Response
Time Frame: Change at 9 months
|
Implementation survey.
Results will be used to optimize intervention from implementation perspective.
|
Change at 9 months
|
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 1 year
|
Motivation survey.
Results will be used to optimize intervention from motivation perspective.
|
Change at 1 year
|
Motivation Survey Response
Time Frame: Change at 9 months
|
Motivation survey.
Results will be used to optimize intervention from motivation perspective.
|
Change at 9 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 1 year
|
Ethical concern survey.
Results will be used to optimize intervention from ethical acceptability perspective.
|
Change at 1 year
|
Ethical Concern Survey Response
Time Frame: Change at 9 months
|
Ethical concern survey.
Results will be used to optimize intervention from ethical acceptability perspective.
|
Change at 9 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
attrition
Time Frame: Change at 1 year
|
rate of attrition
|
Change at 1 year
|
attrition
Time Frame: Change at 9 months
|
rate of attrition
|
Change at 9 months
|
attrition
Time Frame: Change at 6 months
|
rate of attrition
|
Change at 6 months
|
psychotic symptomology
Time Frame: Change at 1 year
|
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 1 year
|
psychotic symptomology
Time Frame: Change at 9 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 9 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 11 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 11 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 1 year
|
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 1 year
|
depression
Time Frame: Change at 9 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 9 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 11 months
|
4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
|
Change at 11 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
|
quality of life
Time Frame: Change at 5 months
|
4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
|
Change at 5 months
|
recovery
Time Frame: Change at 11 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 11 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
|
recovery
Time Frame: Change at 5 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 5 months
|
treatment motivation (intrinsic versus extrinsic)
Time Frame: Change at 11 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 11 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
|
treatment motivation (intrinsic versus extrinsic)
Time Frame: Change at 5 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 5 months
|
Perceived coercion
Time Frame: Change at 11 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 11 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
|
Perceived coercion
Time Frame: Change at 5 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 5 months
|
attendance rate
Time Frame: Change over 1 year
|
number of appointments attended in a given period divided by number of appointments scheduled
|
Change over 1 year
|
attendance rate
Time Frame: Change at 9 months
|
number of appointments attended in a given period divided by number of appointments scheduled
|
Change at 9 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
July 28, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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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