- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335554
Internet Program for Workers With Subthreshold Depression (WorkDep)
Multimedia Internet-Based Program for Workers With Subthreshold Depression
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MoodHacker
Participants in the treatment condition were emailed a link to the MoodHacker mobile-web app and instructed to use the program for the next six weeks.
Participants were asked to complete 2 follow-up assessments, 6 weeks and 10 weeks after baseline.
|
Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.
Other Names:
|
Active Comparator: Alternative Care
Alternative care participants were emailed and encouraged to browse links to vetted online information about depression.
Participants were asked to complete 2 follow-up assessments, 6 weeks and 10 weeks after baseline and were given access to the MoodHacker program after the 10-week assessment
|
Online information about depression from government and other trusted sources to educate users about depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 10 week follow-up
|
Depressive symptomatology was assessed at each assessment point using the self-reported Patient Health Questionnaire-9 scale to assess the nine DSM-IV major depression symptoms.
The PHQ-9 is a self-report version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) and has been shown to be a reliable and valid brief depression assessment tool.
|
10 week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation of positive self-care and life-choice behaviors
Time Frame: 6-week posttest and 10-week follow-up
|
How actively individuals are taking care of themselves, including making positive life choices, was expected to increase as a result of the intervention.
Behavioral activation was measured using the Behavioral Activation for Depression Scale Short Form (BADS).
This scale consists of 9 items.
|
6-week posttest and 10-week follow-up
|
Change in negative thinking
Time Frame: 6-week posttest and 10-week follow-up
|
Change in negative thinking was assessed using the Automatic Thoughts Questionnaire - Revised scale Short Form (ATQ-R-SF).
A 12-item adaptation of the ATQ-R instrument asked respondents to rate how many times over the past week they have had thoughts that are consistent with 12 negative self-statements.
|
6-week posttest and 10-week follow-up
|
Knowledge about depression
Time Frame: 6-week posttest and 10-week follow-up
|
Treatment participants were assessed for an increase in knowledge about depression.
The scale consisted of 14 multiple-choice items based on the 12 learning objectives addressed in the MoodHacker articles and videos.
|
6-week posttest and 10-week follow-up
|
Worker productivity as assessed by the Work Limitations Questionnaire
Time Frame: 6-week posttest and 10-week follow-up
|
Worker productivity was assessed using the Work Limitations Questionnaire (WLQ).
The WLQ Short Form consists of 10 items divided into four subscales measuring the degree to which a person was limited in their job's (1) time demands; (2) physical demands; (3) mental demands; and (4) output demands.
|
6-week posttest and 10-week follow-up
|
Worksite outcomes as assessed by the Workplace Outcomes Suite
Time Frame: 6-week posttest and 10-week follow-up
|
Worksite outcomes were also assessed using the Workplace Outcomes Suite (WOS).
The WOS is designed as an open-access instrument to facilitate empirical research on Employee Assistance Program (EAP) interventions.
The suite contains five 5-item scales that assess: absenteeism, presenteeism, work engagement, life satisfaction, and workplace distress.
|
6-week posttest and 10-week follow-up
|
User satisfaction as assessed by the System Usability Scale
Time Frame: 6 week posttest
|
Treatment participants completed the System Usability Scale, which is a quantitative measure of program ease of use.
The scale includes 10 items.
Users were asked to what degree they agreed or disagreed with program use and satisfaction statements on a 6-point scale (1=strongly disagree; 6=strongly agree).
|
6 week posttest
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amy J Birney, MPH, MCHES, Oregon Center for Applied Science
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81RR-2R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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