DepressionPRIME-DNCT02817672
Evaluating the Feasibility of Disseminating a Novel Mobile Platform to Treat Depression
A study testing PRIME 1.0 and PRIME 2.0 in people with Depression, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this project is to conduct a pilot study to test the utility of a Natural Language Processing (NLP) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (BA) strategies through a mobile mental health app called Personalized… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depression
- What is being tested?
- PRIME 1.0 and PRIME 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2016to 10 Apr 2018
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and older
- Read and speak English
- PHQ-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (Item 10 of the PHQ-9 > 2).
- To be consistent with the NIMH RDoC initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities
- Must own a mobile device on iOS or Android platforms that either Wi-Fi or 3G/4G ready;
Who cannot join
- Under 18
- Cannot read or speak in English
- Cannot attain suitable mobile device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression
The goal of this project is to conduct a pilot study to test the utility of a Natural Language Processing (NLP) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (BA) strategies through a mobile mental health app called Personalized Real-time Intervention for Motivational Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered messaging tool, which will ensure fidelity to the BA model and clinicians will have access to real-time clinical information about their patients to guide more targeted treatment (competence). If successful, PRIME could operate as a cost effective tool for clinicians to extend their reach and an accessible treatment for the population of those struggling with depression.
- Conditions
- Depression
- Being tested
- PRIME 1.0, PRIME 2.0
- Keywords
- Human, Mental Disorders, intervention, digital health
- Medical subject headings
- Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME 1.0Behavioural
Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).
PRIME 2.0Behavioural
Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).
| Study group | Role | What they receive |
|---|---|---|
| PRIME 1.0 | Active comparator | 8 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits. Receives: Behavioral: PRIME 1.0 |
| PRIME 2.0 | Experimental | 8 weeks use of PRIME 2.0 (version with the NLP-powered dashboard). Mobile application designed to improve psychosocial functioning and motivational deficits. Receives: Behavioral: PRIME 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
PhQ-9
Measured: Change from baseline to 3 month follow-up
Functioning
Sheehan Disability Scale
Measured: Change from baseline to 3 month follow-up
Secondary outcomes (2)
Coaching efficiency
Flurry analytics
Measured: 8 weeks
Coaching competence
Fidelity and competence assessment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start25 May 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Why it stopped: The dataset was not strong enough to do NLP analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Schlosser, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817672
- Sponsor's protocol ID
- 1R34MH110583-01
- Acronym
- PRIME-D
- Status last verified
- Jan 2020
- First submitted
- 22 Jun 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
Publications
Schlosser D, Campellone T, Kim D, Truong B, Vergani S, Ward C, Vinogradov S. Feasibility of PRIME: A Cognitive Neuroscience-Informed Mobile App Intervention to Enhance Motivated Behavior and Improve Quality of Life in Recent Onset Schizophrenia. JMIR Res Protoc. 2016 Apr 28;5(2):e77. doi: 10.2196/resprot.5450.
PubMed 27125771Fisher M, Loewy R, Hardy K, Schlosser D, Vinogradov S. Cognitive interventions targeting brain plasticity in the prodromal and early phases of schizophrenia. Annu Rev Clin Psychol. 2013;9:435-63. doi: 10.1146/annurev-clinpsy-032511-143134. Epub 2013 Jan 7.
PubMed 23297786
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling a Smarter and More Efficient Intervention: Evaluating the Feasibility of Disseminating a Novel Mobile App Platform to Treat Depression
- ClinicalTrials.gov ID
- NCT02817672
- Acronym / sponsor ID
- PRIME-D / 1R34MH110583-01
- Conditions
- Depression
- Keywords
- Human, Mental Disorders, intervention, digital health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The dataset was not strong enough to do NLP analysis.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 29 Jun 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.
The goal of this project is to conduct a pilot study to test the utility of a Natural Language Processing (NLP) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (BA) strategies through a mobile mental health app called Personalized Real-time Intervention for Motivational Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered messaging tool, which will ensure fidelity to the BA model and clinicians will have access to real-time clinical information about their patients to guide more targeted treatment (competence). If successful, PRIME could operate as a cost effective tool for clinicians to extend their reach and an accessible treatment for the population of those struggling with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIME 1.0 | Active comparator | Behavioral: PRIME 1.08 weeks use of PRIME 1.0 (current version). Mobile application designed to improve psychosocial functioning and motivational deficits. |
| PRIME 2.0 | Experimental | Behavioral: PRIME 2.08 weeks use of PRIME 2.0 (version with the NLP-powered dashboard). Mobile application designed to improve psychosocial functioning and motivational deficits. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 and older
- Read and speak English
- PHQ-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (Item 10 of the PHQ-9 > 2).
- To be consistent with the NIMH RDoC initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities
- Must own a mobile device on iOS or Android platforms that either Wi-Fi or 3G/4G ready;
Key exclusion criteria (3 listed)
- Under 18
- Cannot read or speak in English
- Cannot attain suitable mobile device
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 |
|---|---|---|
| PRIME 1.0Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard). | Behavioural | PRIME 1.0 |
| PRIME 2.0Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard). | Behavioural | PRIME 2.0 |
Primary outcome
Depression severity
Time frame: Change from baseline to 3 month follow-up
PhQ-9
Functioning
Time frame: Change from baseline to 3 month follow-up
Sheehan Disability Scale
2 secondary outcomes
Coaching efficiency
Time frame: 8 weeks
Coaching competence
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 27125771Schlosser D, Campellone T, Kim D, Truong B, Vergani S, Ward C, Vinogradov S. Feasibility of PRIME: A Cognitive Neuroscience-Informed Mobile App Intervention to Enhance Motivated Behavior and Improve Quality of Life in Recent Onset Schizophrenia. JMIR Res Protoc. 2016 Apr 28;5(2):e77. doi: 10.2196/resprot.5450.
- Background: PubMed 23297786Fisher M, Loewy R, Hardy K, Schlosser D, Vinogradov S. Cognitive interventions targeting brain plasticity in the prodromal and early phases of schizophrenia. Annu Rev Clin Psychol. 2013;9:435-63. doi: 10.1146/annurev-clinpsy-032511-143134. Epub 2013 Jan 7.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Danielle Schlosser, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME 1.0 and PRIME 2.0 in people with Depression, run by University of California, San Francisco 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 5 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: withdrawn, as of the sponsor's last update on 22 Jan 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Depression severity (time frame: Change from baseline to 3 month follow-up). 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 NCT02817672, which also lists 2 linked publications.
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 22 Jan 2020.