Clinical trial NCT01808976: Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.
Official title: Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MDD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sheehan Disability Assessment Scale
timeFrame: Up to 3 weeks
measure: Patient Global Improvement Scale
timeFrame: Up to 3 weeks
measure: Patient Health Questionnaire
timeFrame: Up to 3 weeks
measure: Sheehan Disability Assessment Scale
timeFrame: Week 8
measure: Patient Global Improvement Scale
timeFrame: Week 8
measure: Patient Health Questionnaire
timeFrame: Week 8
measure: Sheehan Disability Assessment Scale
timeFrame: Week 12
measure: Patient Global Improvement Scale
timeFrame: Week 12
measure: Patient Health Questionnaire
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Web-based; log onto www.brightenstudy.com/spa for details
state: California
Study officials:
affiliation: University of Washington
name: Patricia Arean, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pratap 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.