Internet Program for Workers With Subthreshold Depression

Depression Clinical Trial

— WorkDep  

Official title:

Multimedia Internet-Based Program for Workers With Subthreshold Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335554
• Other study ID #: 81RR-2R
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 9, 2015
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: Oregon Center for Applied Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• MoodHacker
Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.
• Alternative Care
Online information about depression from government and other trusted sources to educate users about depression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Center for Applied Science, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9)	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	No
Secondary	Activation of positive self-care and life-choice behaviors	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	No
Secondary	Change in negative thinking	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	No
Secondary	Knowledge about depression	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	No
Secondary	Worker productivity as assessed by the Work Limitations Questionnaire	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	No
Secondary	Worksite outcomes as assessed by the Workplace Outcomes Suite	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	No
Secondary	User satisfaction as assessed by the System Usability Scale	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	No