Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.

MDD Clinical Trial

Official title:

Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808976
• Other study ID #: R34MH100466
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: May 3, 2017
• Start date: April 2013
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MDD

Intervention

Other:
• Problem Solving Therapy
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.

Behavioral:
• Evolution
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 app
This is an app that send daily tips for improving your mood.

Locations

Country	Name	City	State
United States	Web-based; log onto www.brightenstudy.com/spa for details	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sheehan Disability Assessment Scale	Assesses functional impairment in three inter-related domains; work/school, social and family life.	Up to 3 weeks
Primary	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.	Up to 3 weeks
Primary	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.	Up to 3 weeks
Primary	Sheehan Disability Assessment Scale	Assesses functional impairment in three inter-related domains; work/school, social and family life.	Week 8
Primary	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.	Week 8
Primary	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.	Week 8
Primary	Sheehan Disability Assessment Scale	Assesses functional impairment in three inter-related domains; work/school, social and family life.	Week 12
Primary	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.	Week 12
Primary	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.	Week 12