DepressionWorkDepNCT02335554
Internet Program for Workers With Subthreshold Depression
A study testing MoodHacker and Alternative Care in people with Depression, run by Oregon Center for Applied Science, Inc..
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- MoodHacker and Alternative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Multimedia Internet-Based Program for Workers With Subthreshold Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- MoodHacker, Alternative Care
- Keywords
- Subthreshold, Employees, Internet, Mobile, cognitive-behavioral
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodHackerBehavioural
Also called Internet program for workers with subthreshold depression
Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.
Alternative CareBehavioural
Online information about depression from government and other trusted sources to educate users about depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Alternative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 week follow-up
Secondary outcomes (6)
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.
Measured: 6-week posttest and 10-week follow-up
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.
Measured: 6-week posttest and 10-week follow-up
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.
Measured: 6-week posttest and 10-week follow-up
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.
Measured: 6-week posttest and 10-week follow-up
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.
Measured: 6-week posttest and 10-week follow-up
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).
Measured: 6 week posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy J Birney, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335554
- Sponsor's protocol ID
- 81RR-2R
- Acronym
- WorkDep
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26813737
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Internet-Based Program for Workers With Subthreshold Depression
- ClinicalTrials.gov ID
- NCT02335554
- Acronym / sponsor ID
- WorkDep / 81RR-2R
- Conditions
- Depression
- Keywords
- Subthreshold, Employees, Internet, Mobile, cognitive-behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoodHacker | Experimental | Behavioral: MoodHackerParticipants 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. |
| Alternative Care | Active comparator | Behavioral: Alternative CareAlternative 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoodHackerAlso: Internet program for workers with subthreshold depressionMobile-web app to educate users about depression and promote daily mood and positive activity monitoring. | Behavioural | MoodHacker |
| Alternative CareOnline information about depression from government and other trusted sources to educate users about depression. | Behavioural | Alternative Care |
Primary outcome
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.
6 secondary outcomes
Activation of positive self-care and life-choice behaviors
Time frame: 6-week posttest and 10-week follow-up
Change in negative thinking
Time frame: 6-week posttest and 10-week follow-up
Knowledge about depression
Time frame: 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
Worksite outcomes as assessed by the Workplace Outcomes Suite
Time frame: 6-week posttest and 10-week follow-up
User satisfaction as assessed by the System Usability Scale
Time frame: 6 week posttest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Derived from this study: PubMed 26813737Birney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy J Birney, MPH, MCHES principal investigator
Oregon Center for Applied Science
Questions about this trial
What is this clinical trial studying?
A study testing MoodHacker and Alternative Care in people with Depression, run by Oregon Center for Applied Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9) (time frame: 10 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02335554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.