Clinical trial NCT02335554: Internet Program for Workers With Subthreshold Depression
Official title: Multimedia Internet-Based Program for Workers With Subthreshold Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Subthreshold
Employees
Internet
Mobile
cognitive-behavioral
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Depression is one of the most prevalent mental disorders to afflict adults. It seriously impacts role functioning and often takes a recurrent or chronic course. Because most adults who suffer from depression never receive treatment, there is a critical need to develop interventions that can be easily implemented and widely disseminated. Interventions that reduce the performance-impairing symptoms of subclinical depression and prevent the onset of major depression can improve employee well-being, while reducing healthcare costs and improving productivity. This project produced a mobile-web program to activate cognitive behavioral skills in workers with subthreshold depression, reduce depression symptoms, improve functioning in the workplace, and potentially reduce the risk for escalation to full-syndrome depression.

Detailed description: The responsive mobile-web MoodHacker app was designed to: (a) educate users about depression; (b) educate users about the logistics and benefits of mood and activity monitoring; (c) promote daily mood and activity monitoring; (d) help users increase their positive activity engagement; (e) help users decrease negative thinking and increase positive thinking; and (f) promote daily practice of the skills taught.

Program content was adapted from the Coping with Depression group therapy course \[18\], enhanced with mindfulness-based \[22\] and other evidence-based positive psychology strategies \[23-25\]. Content for the application was refined based on input from experts in the field who had extensive experience working with adult employees at risk for depression. Additional program modifications were made based on data from individual interviews and iterative user testing with the population of interest during the formative and production phases of the project.

The MoodHacker user experience is structured around twelve learning objectives delivered through daily emails, in-app messaging, and in the "Articles \& Videos" library. Daily emails (Figure 1) are sent to engage users in program content, provide sequenced guidance through the learning objectives in the articles and whiteboard-style videos, give tips for getting the most out of MoodHacker, and prompt the user to track their mood and activities daily. Users are encouraged to view the articles and videos as ordered, but viewing is not restricted, and users can view content according to their interest. The emails, articles and videos promote practice of the featured cognitive and behavioral skills outside the app experience.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* mild-to-moderate depressive symptoms as measured by the PHQ-9 (score of 10-19)
* not currently suicidal or meeting criteria for bipolar or schizo-affective disorder
* employed at least part-time
* English speaking
* access to a high-speed internet connection

Exclusion Criteria:

* younger than 18 years old
* severe depressive symptoms as measured by the PHQ-9 (score of 20+)
* currently suicidal or meeting criteria for bipolar or schizo-affective disorder
* employed less than part-time or unemployed
* not English speaking
* no access to a high-speed internet connection

Primary outcomes:
measure: Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 10 week follow-up
Secondary outcomes:
measure: Activation of positive self-care and life-choice behaviors
timeFrame: 6-week posttest and 10-week follow-up
measure: Change in negative thinking
timeFrame: 6-week posttest and 10-week follow-up
measure: Knowledge about depression
timeFrame: 6-week posttest and 10-week follow-up
measure: Worker productivity as assessed by the Work Limitations Questionnaire
timeFrame: 6-week posttest and 10-week follow-up
measure: Worksite outcomes as assessed by the Workplace Outcomes Suite
timeFrame: 6-week posttest and 10-week follow-up
measure: User satisfaction as assessed by the System Usability Scale
timeFrame: 6 week posttest
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Center for Applied Science
name: Amy J Birney, MPH, MCHES
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birney AJ, Gunn R, Russell JK, Ary DV. MoodHacker Mobile Web App With Email for Adults to Self-Manage Mild-to-Moderate Depression: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Jan 26;4(1):e8. doi: 10.2196/mhealth.4231.