NCT02335554

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

January 7, 2015

Last Update Submit

January 9, 2015

Conditions

Keywords

SubthresholdEmployeesInternetMobilecognitive-behavioral

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Activation of positive self-care and life-choice behaviors

    6-week posttest and 10-week follow-up

  • Change in negative thinking

    6-week posttest and 10-week follow-up

  • Knowledge about depression

    6-week posttest and 10-week follow-up

  • Worker productivity as assessed by the Work Limitations Questionnaire

    6-week posttest and 10-week follow-up

  • Worksite outcomes as assessed by the Workplace Outcomes Suite

    6-week posttest and 10-week follow-up

  • +1 more secondary outcomes

Study Arms (2)

MoodHacker

EXPERIMENTAL

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.

Behavioral: MoodHacker

Alternative Care

ACTIVE COMPARATOR

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

Behavioral: Alternative Care

Interventions

MoodHackerBEHAVIORAL

Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.

Also known as: Internet program for workers with subthreshold depression
MoodHacker

Online information about depression from government and other trusted sources to educate users about depression.

Alternative Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Interventions

Workforce

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Officials

  • Amy J Birney, MPH, MCHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 12, 2015

Record last verified: 2015-01