SchizophreniaNCT04248517
Using mHealth to Optimize Pharmacotherapy Regimens
A study testing mHealth Intervention in people with Schizophrenia and First-Episode Psychosis, run by New York State Psychiatric Institute at 4 sites in United States.
Trial summary
This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Schizophrenia, First-Episode Psychosis
- What is being tested?
- mHealth Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Oct 2020to 31 Dec 2022
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
- Able and willing to give informed consent and participate in the intervention
- Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.
Who cannot join
- Suicidal at baseline with C-SSRS score 4 or 5.
- PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bestself Behavioral Health, Inc.
Buffalo, New York, 14202
Washington Heights Community Service
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10065
Institute for Family Health
New York, New York, 10453
About this study
This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.
Data collection for NCT04248517 (Using mHealth to Optimize Pharmacotherapy Regimens) was completed in December 2023. Data analysis was underway when human subjects research at NYSPI was suspended on June 23, 2023 and thus study results are not available to be posted. The team will post results as soon as possible.
Read the detailed description
Comprehensive early treatment of individuals experiencing schizophrenia has the potential to alter the course of illness and improve long-term outcomes. Psychotropic medications are a critical component of early treatment strategies. First-episode psychosis (FEP) is a critical time to optimize prescribing but evidence suggests that prescribing for this population is suboptimal.
A contributing factor to these difficulties is thought to be the lack of accurate information about the effects of medications on symptoms, their side effects, as well as their behavioral, cognitive, and emotional correlates. At medication management appointments, prescribers typically rely on patients' recollection of how they were doing over periods of weeks. Such retrospective assessments are problematic as they are vulnerable to the influence of memory difficulties, cognitive biases including recency effects and frequency illusions, and reframing. Recent advances in smartphone technologies (mobile Health; mHealth) may help to overcome many of the limitations of retrospective assessments.
This pilot study will be a collaboration with OnTrackNY, an innovative coordinated specialty care (CSC) program for individuals aged 16-30 who are experiencing FEP. OnTrackNY originated as part of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Implementation and Evaluatoin Study. The initial phase of this project will use input from stakeholders including patients, front-line providers, clinical leaders, and members of the research team to adapt and refine the mHealth intervention to improve feasibility and clinical utility. A pilot study at 3 OnTrackNY sites will then examine its feasibility and effectiveness by comparing the management and outcomes of 60 patients randomly assigned to the mHealth application or usual care.
- Conditions
- Schizophrenia, First-Episode Psychosis
- Being tested
- mHealth Intervention
- Keywords
- mHealth, Schizophrenia, EMA
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionOther
Participants will download the app onto their smartphone and complete ecological momentary assessements
| Study group | Role | What they receive |
|---|---|---|
| mHealth intervention group | Experimental | participants in the mHealth Group will download the app on to their smartphone and complete ecological momentary assessments on 3 consecutive weekdays every 2 weeks for 6 months. Receives: Other: mHealth Intervention |
| Treatment as Usual group | No intervention | participants will undergo their routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months
The TSQM assesses client satisfaction with medication. It comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the patient's last use. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied).The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items.
Measured: baseline to 6 months
change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months
8-item easily scored and administered measurement that is designed to measure client satisfaction with services. The overall score is produced by summing all item responses. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start9 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort with comparison group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Early Treatment Program at Lenox Hill, The Institute for Family Health Center for Counseling at Walton, New York State Psychiatric Institute, Washington Heights Community Service, BestSelf Behavioral Health, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Scott Stroup, New York State Psychiatric Institute
- Investigators
- Scott Stroup, MD, MPH, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248517
- Sponsor's protocol ID
- 7900
- Other IDs
- P50MH115843
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). Data will include baseline demographic data, and baseline and post raw data derived from functioning and symptom measures.
Publications
Stefancic A, Rogers RT, Styke S, Xu X, Buchsbaum R, Nossel I, Cabassa LJ, Stroup TS, Kimhy D. Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. JMIR Ment Health. 2022 Nov 4;9(11):e41482. doi: 10.2196/41482.
PubMed 36331539
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using mHealth to Optimize Pharmacotherapy Regimens
- ClinicalTrials.gov ID
- NCT04248517
- Acronym / sponsor ID
- 7900
- Conditions
- Schizophrenia, First-Episode Psychosis
- Keywords
- mHealth, Schizophrenia, EMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Northwell Health, Early Treatment Program at Lenox Hill, The Institute for Family Health Center for Counseling at Walton, New York State Psychiatric Institute, Washington Heights Community Service, BestSelf Behavioral Health, National Institute of Mental Health (NIMH)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Jan 2020 (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 project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.
Data collection for NCT04248517 (Using mHealth to Optimize Pharmacotherapy Regimens) was completed in December 2023. Data analysis was underway when human subjects research at NYSPI was suspended on June 23, 2023 and thus study results are not available to be posted. The team will post results as soon as possible.
Detailed description
Comprehensive early treatment of individuals experiencing schizophrenia has the potential to alter the course of illness and improve long-term outcomes. Psychotropic medications are a critical component of early treatment strategies. First-episode psychosis (FEP) is a critical time to optimize prescribing but evidence suggests that prescribing for this population is suboptimal.
A contributing factor to these difficulties is thought to be the lack of accurate information about the effects of medications on symptoms, their side effects, as well as their behavioral, cognitive, and emotional correlates. At medication management appointments, prescribers typically rely on patients' recollection of how they were doing over periods of weeks. Such retrospective assessments are problematic as they are vulnerable to the influence of memory difficulties, cognitive biases including recency effects and frequency illusions, and reframing. Recent advances in smartphone technologies (mobile Health; mHealth) may help to overcome many of the limitations of retrospective assessments.
This pilot study will be a collaboration with OnTrackNY, an innovative coordinated specialty care (CSC) program for individuals aged 16-30 who are experiencing FEP. OnTrackNY originated as part of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Implementation and Evaluatoin Study. The initial phase of this project will use input from stakeholders including patients, front-line providers, clinical leaders, and members of the research team to adapt and refine the mHealth intervention to improve feasibility and clinical utility. A pilot study at 3 OnTrackNY sites will then examine its feasibility and effectiveness by comparing the management and outcomes of 60 patients randomly assigned to the mHealth application or usual care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective cohort with comparison group
| Arm | Type | Receives |
|---|---|---|
| mHealth intervention group | Experimental | Other: mHealth Interventionparticipants in the mHealth Group will download the app on to their smartphone and complete ecological momentary assessments on 3 consecutive weekdays every 2 weeks for 6 months. |
| Treatment as Usual group | No intervention | –participants will undergo their routine treatment. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
- Able and willing to give informed consent and participate in the intervention
- Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.
Key exclusion criteria (2 listed)
- Suicidal at baseline with C-SSRS score 4 or 5.
- PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)
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 |
|---|---|---|
| mHealth InterventionParticipants will download the app onto their smartphone and complete ecological momentary assessements | Other | mHealth intervention group |
Primary outcome
change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months
Time frame: baseline to 6 months
The TSQM assesses client satisfaction with medication. It comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the patient's last use. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied).The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items.
change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months
Time frame: baseline to 6 months
8-item easily scored and administered measurement that is designed to measure client satisfaction with services. The overall score is produced by summing all item responses. Scores range from 8 to 32, with higher values indicating higher satisfaction.
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 13 Jul 2026.
- Derived from this study: PubMed 36331539Stefancic A, Rogers RT, Styke S, Xu X, Buchsbaum R, Nossel I, Cabassa LJ, Stroup TS, Kimhy D. Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. JMIR Ment Health. 2022 Nov 4;9(11):e41482. doi: 10.2196/41482.
- Individual participant dataSharing planned: Yes. Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). Data will include baseline demographic data, and baseline and post raw data derived from functioning and symptom measures.
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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.
Scott Stroup, MD, MPH principal investigator
New York State Psychiatric Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention in people with Schizophrenia and First-Episode Psychosis, run by New York State Psychiatric Institute at 4 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 3 inclusion and 2 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months (time frame: baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248517, which also lists 1 linked publication.
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 13 Jul 2026.