DepressionNCT02708940
Participatory Messaging in the UCLA Psychiatry Partial Hospitalization and Intensive Outpatient Programs
A study testing Participatory technology development in people with Depression and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This research project aims to evaluate the feasibility and effectiveness of a new approach to tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP program participants-patients and therapists--will be consented and enrolled by study staff. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Anxiety, Psychosis
- What is being tested?
- Participatory technology development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (over the age of 18) or parents of patients who are minors (between the ages of 6 and 17)
- Enrolled in PHP or IOP programs at Resnick Neuropsychiatric Hospital
- Agree to participate (minors will be required to have parental consent)
- Patient participants will need to be English speaking because text and IVR messages and workshops will be conducted in English.
- Patient must have cellular phone that can receive text messages
- All PHP and IOP staff are eligible and will be invited to participate in workshops and complete surveys.
Who cannot join
- Declines consent or is unwilling to participate in the study
- Does not speak English. Language other than English is an exclusion given resources and capacity of the study
- Patients without a cellular phone that can receive text messages
- Not receiving texts or IVR messages from their program is an exclusion given that it is the intervention we are evaluating
- Patients under the age of 6.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Partial Hospitalization and Intensive Outpatient Programs
Los Angeles, California, 90095
About this study
This research project aims to evaluate the feasibility and effectiveness of a new approach to tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP program participants-patients and therapists--will be consented and enrolled by study staff. Study participants will be invited to workgroups specific to their program to discuss the usability of Chorus and be asked to complete surveys on demographics, satisfaction, self-efficacy, and involvement with Chorus and usability of the tool.
Read the detailed description
The Partial Hospitalization Program (PHP) and Intensive Outpatient Program (IOP) in the Neuropsychatric Hospital at UCLA provide psychiatric services for adults and children with acute mental illness. These include voluntary programs that support individuals in their recovery with the goal to assist patients in achieving the highest level of independence. Most programs operate Monday through Friday between four to eight hours a day. Recently, the PHP and IOP programs have decided to start including mobile messaging as a part of care, helping patients to feel supported even after they have left the hospital for the day.
The purpose of this study is to evaluate the feasibility and effectiveness of their ongoing use of the Chorus Participatory Mobile Framework to support clinical care. Chorus is a framework and web application that allows users to rapidly create a broad range of automated text messaging (SMS), interactive voice (IVR), or mobile web applications using a simple and accessible visual interface without requiring any server programming. There will be two broad populations using Chorus: (1) programs (e.g. OCD Intensive Treatment Program) in which all participants will receive participatory mobile messaging and (2) programs (e.g. Adult Acute PHP) in which patients will be randomized to receive either participatory mobile messaging or no mobile messaging. Across all programs, Kandace Whiting and Armen Arevian will train PHP and IOP therapists starting with creating simple, basic, useful messaging content in Chorus to support patients in achieving program goals. Examples of messages include Cognitive Behavioral Therapy (CBT), symptom management, and stress management cues to patients in the Obsessive Compulsive Disorder Clinic, patients in the Adult Eating Disorder Clinic, and parents from The Achievement, Behavior, Cognition (ABC) Child Programs.
All participating patients receiving participatory mobile messaging will work with program staff one-on-one to tailor SMS and IVR content and design based on their own preferences. By being able to personalize the messaging, the Chorus Participatory Mobile Framework meets the capacities and preferences of the users rather than a "one-size" approach requiring adaptation of the users to the technology. Both therapists and patients will be invited to up to bi-weekly, in-person workshops specific to their program to provide feedback and input. The goal of these workshops is to further develop and refine the novel mobile interventions based on stakeholder input. The Chorus Participatory Framework will be used during the workshops to develop and test the application in real-time. Workshops will be audio and/or video recorded to document the process.
- Conditions
- Depression, Anxiety, Psychosis
- Being tested
- Participatory technology development, Usual Care
- Medical subject headings
- Depression, Anxiety Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory technology developmentOther
Creating mobile support tools by patients and their therapists
Usual CareOther
Usual care as part of the UCLA PHP and IOP programs
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Control arm - these patients will get usual care as part of the PHP and IOP programs at UCLA. They will not receive mobile support messages. Receives: Other: Usual Care |
| Participatory technology development | Active comparator | Intervention - Patients will have access to a website that allows them to co-create mobile support messages with their therapist to support their care as part of the PHP and IOP programs at UCLA. Receives: Other: Participatory technology development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in homework completion rate
the change in the degree to which patients complete tasks assigned to them by their provider as part of their treatment
Measured: Collected on each program attendance day (up to daily), through discharge from program, an average of 12 weeks
Secondary outcomes (9)
length of stay
length of stay (in terms of days and hours/day of program attendance)
Measured: At discharge from program, an average of 12 weeks
time to discharge
time to step down from partial hospitalization program to intensive outpatient program and time to discharge from program
Measured: From admission to program until discharge from program, assessed up to 20 weeks
Number of patient visits to health care organizations outside of clinic
the number of services that patients utilize outside of the clinic, including ED visits and inpatient hospitalizations.
Measured: at patient disenrollment from study, approximately 3 months after discharge from program, up to 40 weeks
Types of health care services patients utilize outside of clinic
the types of services that patients utilize outside of the clinic, including ED visits and inpatient hospitalizations.
Measured: at patient disenrollment from study, approximately 3 months after discharge from program, up to 40 weeks
change in depression symptoms
PHQ-9 to measure changes in depression symptoms
Measured: Upon admission to program, at mid-point of stay in program, at discharge from program (may also be up to weekly during stay), an average of 12 weeks; and 3 months after discharge from programa
Change in Patient Treatment Self-Efficacy
change patient treatment self-efficacy from week-to-week during program
Measured: weekly during stay in program, through discharge from program, an average of 12 weeks
Difference in Patient Satisfaction with Program between Intervention vs Control groups
comparing patient satisfaction with services and support between the intervention and control groups
Measured: at discharge from program, an average of 12 weeks
Messaging Application Usability
Weekly survey of patients in the intervention arm and all providers to assess the usability of the messaging application
Measured: weekly during stay in program, through discharge from program, an average of 12 weeks
Patient Involvement in Message Development
Completed by patients in the intervention arm and by provider for each patient in intervention arm to assess the extent of patient involvement in the development of message content and schedule, and use of messaging application
Measured: weekly during stay in program, through discharge from program, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708940
- Sponsor's protocol ID
- IRB#14-001879
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2016
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Messaging in the UCLA Psychiatry Partial Hospitalization and Intensive Outpatient Programs
- ClinicalTrials.gov ID
- NCT02708940
- Acronym / sponsor ID
- IRB#14-001879
- Conditions
- Depression, Anxiety, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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 research project aims to evaluate the feasibility and effectiveness of a new approach to tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP program participants-patients and therapists--will be consented and enrolled by study staff. Study participants will be invited to workgroups specific to their program to discuss the usability of Chorus and be asked to complete surveys on demographics, satisfaction, self-efficacy, and involvement with Chorus and usability of the tool.
Detailed description
The Partial Hospitalization Program (PHP) and Intensive Outpatient Program (IOP) in the Neuropsychatric Hospital at UCLA provide psychiatric services for adults and children with acute mental illness. These include voluntary programs that support individuals in their recovery with the goal to assist patients in achieving the highest level of independence. Most programs operate Monday through Friday between four to eight hours a day. Recently, the PHP and IOP programs have decided to start including mobile messaging as a part of care, helping patients to feel supported even after they have left the hospital for the day.
The purpose of this study is to evaluate the feasibility and effectiveness of their ongoing use of the Chorus Participatory Mobile Framework to support clinical care. Chorus is a framework and web application that allows users to rapidly create a broad range of automated text messaging (SMS), interactive voice (IVR), or mobile web applications using a simple and accessible visual interface without requiring any server programming. There will be two broad populations using Chorus: (1) programs (e.g. OCD Intensive Treatment Program) in which all participants will receive participatory mobile messaging and (2) programs (e.g. Adult Acute PHP) in which patients will be randomized to receive either participatory mobile messaging or no mobile messaging. Across all programs, Kandace Whiting and Armen Arevian will train PHP and IOP therapists starting with creating simple, basic, useful messaging content in Chorus to support patients in achieving program goals. Examples of messages include Cognitive Behavioral Therapy (CBT), symptom management, and stress management cues to patients in the Obsessive Compulsive Disorder Clinic, patients in the Adult Eating Disorder Clinic, and parents from The Achievement, Behavior, Cognition (ABC) Child Programs.
All participating patients receiving participatory mobile messaging will work with program staff one-on-one to tailor SMS and IVR content and design based on their own preferences. By being able to personalize the messaging, the Chorus Participatory Mobile Framework meets the capacities and preferences of the users rather than a "one-size" approach requiring adaptation of the users to the technology. Both therapists and patients will be invited to up to bi-weekly, in-person workshops specific to their program to provide feedback and input. The goal of these workshops is to further develop and refine the novel mobile interventions based on stakeholder input. The Chorus Participatory Framework will be used during the workshops to develop and test the application in real-time. Workshops will be audio and/or video recorded to document the process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual CareControl arm - these patients will get usual care as part of the PHP and IOP programs at UCLA. They will not receive mobile support messages. |
| Participatory technology development | Active comparator | Other: Participatory technology developmentIntervention - Patients will have access to a website that allows them to co-create mobile support messages with their therapist to support their care as part of the PHP and IOP programs at UCLA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (over the age of 18) or parents of patients who are minors (between the ages of 6 and 17)
- Enrolled in PHP or IOP programs at Resnick Neuropsychiatric Hospital
- Agree to participate (minors will be required to have parental consent)
- Patient participants will need to be English speaking because text and IVR messages and workshops will be conducted in English.
- Patient must have cellular phone that can receive text messages
Key exclusion criteria (5 listed)
- Declines consent or is unwilling to participate in the study
- Does not speak English. Language other than English is an exclusion given resources and capacity of the study
- Patients without a cellular phone that can receive text messages
- Not receiving texts or IVR messages from their program is an exclusion given that it is the intervention we are evaluating
- Patients under the age of 6.
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 |
|---|---|---|
| Participatory technology developmentCreating mobile support tools by patients and their therapists | Other | Participatory technology development |
| Usual CareUsual care as part of the UCLA PHP and IOP programs | Other | Usual care |
Primary outcome
Change in homework completion rate
Time frame: Collected on each program attendance day (up to daily), through discharge from program, an average of 12 weeks
the change in the degree to which patients complete tasks assigned to them by their provider as part of their treatment
9 secondary outcomes
length of stay
Time frame: At discharge from program, an average of 12 weeks
time to discharge
Time frame: From admission to program until discharge from program, assessed up to 20 weeks
Number of patient visits to health care organizations outside of clinic
Time frame: at patient disenrollment from study, approximately 3 months after discharge from program, up to 40 weeks
Types of health care services patients utilize outside of clinic
Time frame: at patient disenrollment from study, approximately 3 months after discharge from program, up to 40 weeks
change in depression symptoms
Time frame: Upon admission to program, at mid-point of stay in program, at discharge from program (may also be up to weekly during stay), an average of 12 weeks; and 3 months after discharge from programa
Change in Patient Treatment Self-Efficacy
Time frame: weekly during stay in program, through discharge from program, an average of 12 weeks
Difference in Patient Satisfaction with Program between Intervention vs Control groups
Time frame: at discharge from program, an average of 12 weeks
Messaging Application Usability
Time frame: weekly during stay in program, through discharge from program, an average of 12 weeks
Patient Involvement in Message Development
Time frame: weekly during stay in program, through discharge from program, an average of 12 weeks
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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 Participatory technology development in people with Depression and Anxiety, run by University of California, Los Angeles 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 6 inclusion and 5 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 7 Nov 2023. 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?
Change in homework completion rate (time frame: Collected on each program attendance day (up to daily), through discharge from program, an average of 12 weeks). 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 7 Nov 2023.