MDDNCT01808976
Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.
A study testing Problem Solving Therapy, Evolution and Basic health push app in people with MDD, run by University of California, San Francisco at 1 site in United States.
Trial summary
Over two million people in the US download health apps onto their smartphones and tablets, with the intent of improving their quality of life. Despite widespread use of these apps, there is relatively little information regarding app user access (do users download health apps and use them more than once), app user… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MDD
- What is being tested?
- Problem Solving Therapy, Evolution and Basic health push app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- must own smart device (iPhone or ANDROID + iPAD)
- a total score of 5 or greater on the PHQ-9; OR a score of 2 or greater on at least one of the first two PHQ-9 items AND a score of 2 or greater on the 10th PHQ-9 item
- English speaking* (* as of 12/2016: this arm is closed)
- Spanish speaking (1st or second language)
Who cannot join
- below 18 years or older
- does not own a smart device
- a total score of less than 5 on the PHQ-9
- less than a score of 2 on the first two PHQ-9 items and less than 2 on the 10th PHQ-9 item
Trial locations and contacts
1 site in 1 country.
United States1 site
Web-based; log onto www.brightenstudy.com/spa for details
San Francisco, California, 94110
About this study
Over two million people in the US download health apps onto their smartphones and tablets, with the intent of improving their quality of life. Despite widespread use of these apps, there is relatively little information regarding app user access (do users download health apps and use them more than once), app user engagement (do users follow the app protocols) and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a future randomized controlled trial investigating access, engagement and impact of two types of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a cognitive training game called Evolution) and compare both to an information only app. Our intent is to conduct this study entirely on mobile devices, in order to investigate access, engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to test the feasibility of conducting our future randomized controlled trial comparing three mobile mental health apps for the management of depressed mood, improvement of cognitive control, and improvement in activities of daily living in people aged 18 and older. Recruitment, consent, randomization, app use and outcome assessment will be conducted entirely on mobile devices. We will recruit 150 people through four different recruitment avenues to determine which avenue results in the most representative sample of our target population (people 18 and older who have symptoms of depression that are interfering with their quality of life). We will also determine the number we need to recruit to have a final sample of 150 people willing to be randomized between the 3 apps and complete an 12-week study of app impact on mood, cognition and function. This pilot will provide information on the completeness of data from a study conducted in this manner, and uncover any other challenges we may face by using mobile devices for data collection, and if we will find differential drop out between app type (e.g.: will more people stop using of the information only app prematurely?). Although we will not have sufficient statistical power to answer questions about comparative effectiveness between the apps, we plan to explore relationships between sample demographics, app use, and improvement in cognitive control on improvements in mood and function.
Read the detailed description
Participants will be recruited nationally from a variety of on-line sources. Participants will complete a breif on-line survey and then randomized to one of three mobile apps for depression. Participants are expected to use the apps for 4 weeks, complete daily ratings of mood, as well as complete 4 comprehensive assessments on their smart devices at weeks 1, 4, 8 and 12.
- Conditions
- MDD
- Being tested
- Problem Solving Therapy, Evolution, Basic health push app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyOther
this is a mobile app that participants use to solve problems. It will guide participants through a stepwise process for identifying a means for creating action plans.
EvolutionBehavioural
This is a therapeutic video game that targets the cognitive control network, associated with depression. Participants are expected to play the game daily for 20 minutes over 4 weeks.
Basic health push appBehavioural
This is an app that send daily tips for improving your mood.
| Study group | Role | What they receive |
|---|---|---|
| Evolution | Active comparator | This app is designed to be a cognitive training game that conditions the CCN. This is done by having participants play a multitasking game that targets their perceptual discrimination abilities, selective attention, and visuomotor tracking skills. At the first session, participants will be directed to an initial assessment of each of these cognitive control skills in a single task and dual-task setting (a total of 3 different diagnostics, described below). Each week, this diagnostic phase will reflect the training paradigm they will encounter for that week, as each week the perceptual and tracking challenges will increase. Receives: Behavioral: Evolution |
| Problem Solving Therapy | Experimental | This app is based on the social problem solving protocol developed by Nezu and D'Zurilla . The app begins with explaining the PST steps. Participants are informed that they can learn each step one session at a time, or they can chose to learn all the steps at once. After each step completed, participants are asked if they want to continue onto the next step or save it for the next session, thus the app tailors itself to the users ability to absorb new information. Receives: Other: Problem Solving Therapy |
| Basic health push app | Active comparator | This app provides daily suggestions for overcoming depressed mood and allows users to track their mood, using the 0-9 scale available for all three apps. In the first app session, participants are given a general education about depression and its known causes and consequences. Participants are told that to overcome mood problems, they must engage in one mood improvement strategy a day and that the app will suggest one to try each day. Receives: Behavioral: Basic health push app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sheehan Disability Assessment Scale
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Measured: Up to 3 weeks
Patient Global Improvement Scale
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Up to 3 weeks
Patient Health Questionnaire
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
Measured: Up to 3 weeks
Sheehan Disability Assessment Scale
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Measured: Week 8
Patient Global Improvement Scale
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Week 8
Patient Health Questionnaire
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
Measured: Week 8
Sheehan Disability Assessment Scale
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Measured: Week 12
Patient Global Improvement Scale
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Week 12
Patient Health Questionnaire
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2017
- Study completionFeb 2017
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 MDDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin Anguera, University of California, San Francisco
- Investigators
- Patricia Arean, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808976
- Sponsor's protocol ID
- R34MH100466
- Status last verified
- May 2017
- First submitted
- 7 Mar 2013
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We plan to release data for sharing once the study is complete.
Publications
Renn BN, Pratap A, Atkins DC, Mooney SD, Arean PA. Smartphone-Based Passive Assessment of Mobility in Depression: Challenges and Opportunities. Ment Health Phys Act. 2018 Mar;14:136-139. doi: 10.1016/j.mhpa.2018.04.003. Epub 2018 Apr 18.
PubMed 30123324Pratap A, Renn BN, Volponi J, Mooney SD, Gazzaley A, Arean PA, Anguera JA. Using Mobile Apps to Assess and Treat Depression in Hispanic and Latino Populations: Fully Remote Randomized Clinical Trial. J Med Internet Res. 2018 Aug 9;20(8):e10130. doi: 10.2196/10130.
PubMed 30093372
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.
- ClinicalTrials.gov ID
- NCT01808976
- Acronym / sponsor ID
- R34MH100466
- Conditions
- MDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Mar 2013 (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.
Over two million people in the US download health apps onto their smartphones and tablets, with the intent of improving their quality of life. Despite widespread use of these apps, there is relatively little information regarding app user access (do users download health apps and use them more than once), app user engagement (do users follow the app protocols) and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a future randomized controlled trial investigating access, engagement and impact of two types of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a cognitive training game called Evolution) and compare both to an information only app. Our intent is to conduct this study entirely on mobile devices, in order to investigate access, engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to test the feasibility of conducting our future randomized controlled trial comparing three mobile mental health apps for the management of depressed mood, improvement of cognitive control, and improvement in activities of daily living in people aged 18 and older. Recruitment, consent, randomization, app use and outcome assessment will be conducted entirely on mobile devices. We will recruit 150 people through four different recruitment avenues to determine which avenue results in the most representative sample of our target population (people 18 and older who have symptoms of depression that are interfering with their quality of life). We will also determine the number we need to recruit to have a final sample of 150 people willing to be randomized between the 3 apps and complete an 12-week study of app impact on mood, cognition and function. This pilot will provide information on the completeness of data from a study conducted in this manner, and uncover any other challenges we may face by using mobile devices for data collection, and if we will find differential drop out between app type (e.g.: will more people stop using of the information only app prematurely?). Although we will not have sufficient statistical power to answer questions about comparative effectiveness between the apps, we plan to explore relationships between sample demographics, app use, and improvement in cognitive control on improvements in mood and function.
Detailed description
Participants will be recruited nationally from a variety of on-line sources. Participants will complete a breif on-line survey and then randomized to one of three mobile apps for depression. Participants are expected to use the apps for 4 weeks, complete daily ratings of mood, as well as complete 4 comprehensive assessments on their smart devices at weeks 1, 4, 8 and 12.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Evolution | Active comparator | Behavioral: EvolutionThis app is designed to be a cognitive training game that conditions the CCN. This is done by having participants play a multitasking game that targets their perceptual discrimination abilities, selective attention, and visuomotor tracking skills. At the first session, participants will be directed to an initial assessment of each of these cognitive control skills in a single task and dual-task setting (a total of 3 different diagnostics, described below). Each week, this diagnostic phase will reflect the training paradigm they will encounter for that week, as each week the perceptual and tracking challenges will increase. |
| Problem Solving Therapy | Experimental | Other: Problem Solving TherapyThis app is based on the social problem solving protocol developed by Nezu and D'Zurilla . The app begins with explaining the PST steps. Participants are informed that they can learn each step one session at a time, or they can chose to learn all the steps at once. After each step completed, participants are asked if they want to continue onto the next step or save it for the next session, thus the app tailors itself to the users ability to absorb new information. |
| Basic health push app | Active comparator | Behavioral: Basic health push appThis app provides daily suggestions for overcoming depressed mood and allows users to track their mood, using the 0-9 scale available for all three apps. In the first app session, participants are given a general education about depression and its known causes and consequences. Participants are told that to overcome mood problems, they must engage in one mood improvement strategy a day and that the app will suggest one to try each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- must own smart device (iPhone or ANDROID + iPAD)
- a total score of 5 or greater on the PHQ-9; OR a score of 2 or greater on at least one of the first two PHQ-9 items AND a score of 2 or greater on the 10th PHQ-9 item
- English speaking* (* as of 12/2016: this arm is closed)
- Spanish speaking (1st or second language)
Key exclusion criteria (4 listed)
- below 18 years or older
- does not own a smart device
- a total score of less than 5 on the PHQ-9
- less than a score of 2 on the first two PHQ-9 items and less than 2 on the 10th PHQ-9 item
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 |
|---|---|---|
| Problem Solving Therapythis is a mobile app that participants use to solve problems. It will guide participants through a stepwise process for identifying a means for creating action plans. | Other | Problem Solving Therapy |
| EvolutionThis is a therapeutic video game that targets the cognitive control network, associated with depression. Participants are expected to play the game daily for 20 minutes over 4 weeks. | Behavioural | Evolution |
| Basic health push appThis is an app that send daily tips for improving your mood. | Behavioural | Basic health push app |
Primary outcome
Sheehan Disability Assessment Scale
Time frame: Up to 3 weeks
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Patient Global Improvement Scale
Time frame: Up to 3 weeks
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Patient Health Questionnaire
Time frame: Up to 3 weeks
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
Sheehan Disability Assessment Scale
Time frame: Week 8
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Patient Global Improvement Scale
Time frame: Week 8
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Patient Health Questionnaire
Time frame: Week 8
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
Sheehan Disability Assessment Scale
Time frame: Week 12
Assesses functional impairment in three inter-related domains; work/school, social and family life.
Patient Global Improvement Scale
Time frame: Week 12
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Patient Health Questionnaire
Time frame: Week 12
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment.
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 4 May 2017.
- Derived from this study: PubMed 30123324Renn BN, Pratap A, Atkins DC, Mooney SD, Arean PA. Smartphone-Based Passive Assessment of Mobility in Depression: Challenges and Opportunities. Ment Health Phys Act. 2018 Mar;14:136-139. doi: 10.1016/j.mhpa.2018.04.003. Epub 2018 Apr 18.
- Derived from this study: PubMed 30093372Pratap A, Renn BN, Volponi J, Mooney SD, Gazzaley A, Arean PA, Anguera JA. Using Mobile Apps to Assess and Treat Depression in Hispanic and Latino Populations: Fully Remote Randomized Clinical Trial. J Med Internet Res. 2018 Aug 9;20(8):e10130. doi: 10.2196/10130.
- Individual participant dataSharing planned: Yes. We plan to release data for sharing once the study is complete.
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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.
Patricia Arean, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy, Evolution and Basic health push app in people with MDD, 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 4 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 4 May 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?
Sheehan Disability Assessment Scale (time frame: Up to 3 weeks). The study lists 9 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 NCT01808976, 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 4 May 2017.