PsychosisBHCOEMobiNCT03286595
Smartphone Applications Youth With Early Psychosis in Community Outpatient Settings
A study testing Mobi mHealth app in people with Psychosis and Clinical High Risk for Psychosis, run by University of California, Davis at 1 site in United States.
Trial summary
The project aims to test the utility of implementing a mobile health application ("mhealth app") in early psychosis care in the community outpatient setting and in the university medical center setting. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Psychosis, Clinical High Risk for Psychosis
- What is being tested?
- Mobi mHealth app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2015to 31 Dec 2016
- 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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inclusion criteria for EP and CHR participants are: age 13-30 years, English fluency, and receiving clinical care at one of three UC Davis affiliated early psychosis clinics in the Northern California region: 1) UC Davis Early Psychosis Program (SacEDAPT \& EDAPT clinics); 2) Aldea Solano SOAR Program; 3) Aldea Napa SOAR program.
- CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year.
- FEP participants will be ascertained within three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria.
Who cannot join
- IQ below 70
- history neurological disorders
- current substance abuse/dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Imaging Research Center
Sacramento, California, 95817
About this study
Official title: Smartphone Applications For Use in Youth With Early Psychosis in Community Outpatient Settings
The project aims to test the utility of implementing a mobile health application ("mhealth app") in early psychosis care in the community outpatient setting and in the university medical center setting. We will enroll 60 individuals in the early stages of psychotic illness who are receiving care in two UC Davis affiliated community based early psychosis outpatient programs: the Aldea Child and Family Services SOAR Programs in Napa and Solano Counties (Napa SOAR, and Solano SOAR), as well as the UC Davis Early Psychosis Programs (EDAPT and SacEDAPT clinics). Early psychosis (EP) participants will include individuals at high risk for developing a psychotic illness (termed "clinical high risk" or CHR) and individuals within two years of their first psychotic episode (termed "first episode psychosis" or FEP). Over the course of five months, EP participants will use the app on their mobile device to complete daily surveys assessing mood, social interactions and medication adherence, and weekly surveys assessing clinical symptoms, sleep and medication adherence. EP participants will also complete clinical assessments with UC Davis research staff at the initial and final study appointments (baseline and five month timepoints). Clinicians working in the three early psychosis programs will also participate in the study. In their clinical role, they will interact with EP participants' app data via the Dashboard, a secure web-based portal, and provide feedback on the clinical utility of the data that is provided on the dashboard. EP participants and their clinicians will also provide feedback on the impact of the app on the therapeutic relationship.
Read the detailed description
Although remission of psychotic symptoms following a patient's first episode of psychosis is achievable through pharmacological and psychosocial treatment, 50% of patients relapse within two years; 80% relapse within five. Relapse, defined as a recurrence of positive psychotic symptoms, is associated with cumulative increases in levels of psychotic symptoms following recovery, decreased social and community functioning, decreased quality of life, and increased hospitalizations. Given the negative impact on patients and their families, and the increasing cost of services as a function of relapse, development of effective relapse prevention strategies is imperative. Predictors of relapse amenable to treatment include: 1) clinical factors such as an exacerbation of clinical symptoms indicative of impending relapse; 2) treatment engagement factors such as medication adherence and therapeutic alliance; and 3) functioning factors such social impairments. Using mobile health technology in a community based outpatient clinic, we propose to specifically address these three types of relapse predictor variables.
The mobile health application tested in this study provides a user interface and a provider interface. The user interface is the mobile application (i.e. the "app") that patients interact with via their smartphone. This is designed to be simple and easily accessible. The app gathers "active" data, i.e. self-report surveys, which the user is alerted to via notifications on their device. Active data are analyzed and summarized for each patient on the "Dashboard", a provider-facing web portal for accessing concise and relevant information about a patient. The Dashboard provides up-to-date information regarding a patient's survey responses. Providers then use this information to better inform treatment decisions.
Specific aims and associated hypotheses are as follows:
Aim 1: Determine the feasibility and acceptability of the mhealth app in a community based outpatient early psychosis population. Hypothesis a: EPs will show high utilization of the mhealth app and low dropout, as well as high satisfaction and endorsement of continued use of the app. Hypothesis b: Clinicians will report high satisfaction and endorsement of continued use of the app.
Aim 2: Identify mhealth data related to key patient outcomes to inform calibration of patient status alerts. Hypothesis: Reductions in phone calls/text messages and/or increases in self-reported ratings of basic symptoms will predict psychotic symptom flares, increased clinic utilization, psychiatric ER visits and hospitalizations.
Aim 3: Evaluate the effect of the mhealth app on medication adherence, therapeutic alliance, and insight. Hypothesis a: After five months of app use, patients will report improved medication adherence, therapeutic alliance with their clinicians, and insight into their illness. Hypothesis b: After five months of use, clinicians will report improved therapeutic alliance with their patients.
- Conditions
- Psychosis, Clinical High Risk for Psychosis
- Being tested
- Mobi mHealth app
- Keywords
- early psychosis, clinical high risk, mobile health
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobi mHealth appOther
Mobile application (i.e. the "app") that patients interact with via their smartphone to collect daily and weekly survey information. Data is visualized on a clinician-facing Dashboard, which can be used to inform treatment.
| Study group | Role | What they receive |
|---|---|---|
| Early Psychosis (EP) | Experimental | EP participants will be individuals who are either a) at clinical high risk (CHR) for developing psychosis and/or bipolar disorder, or b) First Episode Psychosis (FEP) participants meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. Receives: Other: Mobi mHealth app |
| Clinicians | Experimental | Clinicians/treatment team members who are providing treatment services to the EP participants at one of the three early psychosis clinics. Receives: Other: Mobi mHealth app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited).
Measured: 18 months
Acceptability/Satisfaction
Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.
Measured: 18 months
Brief Psychiatric Rating Scale (BPRS)
a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.
Measured: 18 months
Critical incidents
Includes information from patient chart: increased clinic contact, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.
Measured: 18 months
The Clinical Global Impression-Schizophrenia scale (Haro et al., 2003)
is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.
Measured: 18 months
Secondary outcomes (3)
Medication adherence
The MARS (Thompson et al., 2000) is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.
Measured: 18 months
Therapeutic Alliance
Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version).
Measured: 18 months
Insight
Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start19 Aug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286595
- Sponsor's protocol ID
- 782574
- Acronym
- BHCOEMobi
- Status last verified
- Sep 2017
- First submitted
- 24 Jul 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Applications For Use in Youth With Early Psychosis in Community Outpatient Settings
- ClinicalTrials.gov ID
- NCT03286595
- Acronym / sponsor ID
- BHCOEMobi / 782574
- Conditions
- Psychosis, Clinical High Risk for Psychosis
- Keywords
- early psychosis, clinical high risk, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Sep 2017 (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.
The project aims to test the utility of implementing a mobile health application ("mhealth app") in early psychosis care in the community outpatient setting and in the university medical center setting. We will enroll 60 individuals in the early stages of psychotic illness who are receiving care in two UC Davis affiliated community based early psychosis outpatient programs: the Aldea Child and Family Services SOAR Programs in Napa and Solano Counties (Napa SOAR, and Solano SOAR), as well as the UC Davis Early Psychosis Programs (EDAPT and SacEDAPT clinics). Early psychosis (EP) participants will include individuals at high risk for developing a psychotic illness (termed "clinical high risk" or CHR) and individuals within two years of their first psychotic episode (termed "first episode psychosis" or FEP). Over the course of five months, EP participants will use the app on their mobile device to complete daily surveys assessing mood, social interactions and medication adherence, and weekly surveys assessing clinical symptoms, sleep and medication adherence. EP participants will also complete clinical assessments with UC Davis research staff at the initial and final study appointments (baseline and five month timepoints). Clinicians working in the three early psychosis programs will also participate in the study. In their clinical role, they will interact with EP participants' app data via the Dashboard, a secure web-based portal, and provide feedback on the clinical utility of the data that is provided on the dashboard. EP participants and their clinicians will also provide feedback on the impact of the app on the therapeutic relationship.
Detailed description
Although remission of psychotic symptoms following a patient's first episode of psychosis is achievable through pharmacological and psychosocial treatment, 50% of patients relapse within two years; 80% relapse within five. Relapse, defined as a recurrence of positive psychotic symptoms, is associated with cumulative increases in levels of psychotic symptoms following recovery, decreased social and community functioning, decreased quality of life, and increased hospitalizations. Given the negative impact on patients and their families, and the increasing cost of services as a function of relapse, development of effective relapse prevention strategies is imperative. Predictors of relapse amenable to treatment include: 1) clinical factors such as an exacerbation of clinical symptoms indicative of impending relapse; 2) treatment engagement factors such as medication adherence and therapeutic alliance; and 3) functioning factors such social impairments. Using mobile health technology in a community based outpatient clinic, we propose to specifically address these three types of relapse predictor variables.
The mobile health application tested in this study provides a user interface and a provider interface. The user interface is the mobile application (i.e. the "app") that patients interact with via their smartphone. This is designed to be simple and easily accessible. The app gathers "active" data, i.e. self-report surveys, which the user is alerted to via notifications on their device. Active data are analyzed and summarized for each patient on the "Dashboard", a provider-facing web portal for accessing concise and relevant information about a patient. The Dashboard provides up-to-date information regarding a patient's survey responses. Providers then use this information to better inform treatment decisions.
Specific aims and associated hypotheses are as follows:
Aim 1: Determine the feasibility and acceptability of the mhealth app in a community based outpatient early psychosis population. Hypothesis a: EPs will show high utilization of the mhealth app and low dropout, as well as high satisfaction and endorsement of continued use of the app. Hypothesis b: Clinicians will report high satisfaction and endorsement of continued use of the app.
Aim 2: Identify mhealth data related to key patient outcomes to inform calibration of patient status alerts. Hypothesis: Reductions in phone calls/text messages and/or increases in self-reported ratings of basic symptoms will predict psychotic symptom flares, increased clinic utilization, psychiatric ER visits and hospitalizations.
Aim 3: Evaluate the effect of the mhealth app on medication adherence, therapeutic alliance, and insight. Hypothesis a: After five months of app use, patients will report improved medication adherence, therapeutic alliance with their clinicians, and insight into their illness. Hypothesis b: After five months of use, clinicians will report improved therapeutic alliance with their patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Psychosis (EP) | Experimental | Other: Mobi mHealth appEP participants will be individuals who are either a) at clinical high risk (CHR) for developing psychosis and/or bipolar disorder, or b) First Episode Psychosis (FEP) participants meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. |
| Clinicians | Experimental | Other: Mobi mHealth appClinicians/treatment team members who are providing treatment services to the EP participants at one of the three early psychosis clinics. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Inclusion criteria for EP and CHR participants are: age 13-30 years, English fluency, and receiving clinical care at one of three UC Davis affiliated early psychosis clinics in the Northern California region: 1) UC Davis Early Psychosis Program (SacEDAPT \& EDAPT clinics); 2) Aldea Solano SOAR Program; 3) Aldea Napa SOAR program.
- CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year.
- FEP participants will be ascertained within three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria.
Key exclusion criteria (3 listed)
- IQ below 70
- history neurological disorders
- current substance abuse/dependence
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 |
|---|---|---|
| Mobi mHealth appMobile application (i.e. the "app") that patients interact with via their smartphone to collect daily and weekly survey information. Data is visualized on a clinician-facing Dashboard, which can be used to inform treatment. | Other | Clinicians, Early Psychosis (EP) |
Primary outcome
Feasibility
Time frame: 18 months
Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited).
Acceptability/Satisfaction
Time frame: 18 months
Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.
Brief Psychiatric Rating Scale (BPRS)
Time frame: 18 months
a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.
Critical incidents
Time frame: 18 months
Includes information from patient chart: increased clinic contact, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.
The Clinical Global Impression-Schizophrenia scale (Haro et al., 2003)
Time frame: 18 months
is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.
3 secondary outcomes
Medication adherence
Time frame: 18 months
Therapeutic Alliance
Time frame: 18 months
Insight
Time frame: 18 months
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 18 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobi mHealth app in people with Psychosis and Clinical High Risk for Psychosis, run by University of California, Davis at 1 site 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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.