- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346591
Mobile-Web Emotion Self-management Tool (Emotions)
Emotion Management Training: An Innovative Stress Reduction Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of the Jauntly mobile app was to experience exercises that encourage one to take care of oneself emotionally, improve positive emotions, and decrease stress and other negative emotions. The user interacted with the app through evidence-based activities (e.g. writing gratefulness notes, helping others, practicing mindfulness). The activities were selected based on the goals the user selected upon initiation of program and throughout engagement with the app. In order to promote sustained use of the program and mastery of the positive emotion based skills, the design of the program included activities that range in difficulty so that the user could progress and improve (i.e., simple "1 and done" types of goals versus multi-week goals).
Research in positive psychology interventions suggests that increases in well-being are highest when the activity: 1) fits the person's interests and values and 2) is performed neither too frequently nor too seldom. Because of our desire to have a product with long-lasting usability and sustained engagement, it was critical that there were a diverse number of activities from which individuals could choose based on interest, current mood, and past success. The Jauntly user experience is structured around free use of the app partnered with regular emails, in-app messaging, videos, and articles. Emails remind users to utilize program content (including users in the control group who were reminded to visit the stress-management website). Use of the app and viewing of videos and other content is not restricted and users are able to self-tailor use according to their interest.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
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Eugene, Oregon, United States, 97401
- Oregon Center for Applied Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Employed at least part-time
- Self-report stress at work
- English speaking
- Access to a computer with high-speed internet connection, audio-video capability and an active email account
Exclusion Criteria:
- High level of self-reported grief
- High level of self-reported depression (PHQ-2)
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: Jauntly
Mobile app designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience; goal was to lead users through research-proven positive emotion enhancing exercises and relevant educational materials.
Intervention activities covered five well-being generating content areas: 1) promoting the experience and recognition of gratitude; 2) encouraging positive social relationships and feelings of social support; 3) improving stress resilience via mindfulness and other relaxation-focused activities; 4) focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses); and 5) general positive mood inducing activities.
|
Mobile app designed to encourage positive emotion-enhancing and stress reduction activities.
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Active Comparator: Online stress management information
The control participants were emailed links to vetted online information about stress and encouraged to visit the websites.
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Online educational information about stress management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall perceived stress
Time Frame: 12 weeks
|
The 10-item Perceived Stress Scale (PSS) assessed perceptions of feeling like you can not cope with things in your life and feelings of "stress" and nervousness on a scale of 1 (Never) to 5 (Very Often).
The PSS is the most widely used self-report stress scale available, and has been shown to predict many important well-being outcomes.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological well-being assessed as positive and negative affect
Time Frame: 8 weeks, 12 weeks
|
Positive and negative affect over the past few weeks was assessed at each time point using the Positive and Negative Affect Scale-expanded version, with a few nonrelevant items (e.g., surprise) removed, resulting in a total of 53 emotion adjectives on a scale of 1 (not at all/very slightly) to 5 (extremely).
Subscales assessing positive affect (PA) and negative affect (NA) were created as well as specific basic emotion scales assessing fear (6 items), hostility (6 items), guilt (6 items), sadness (5 items), joviality (8 items), self-assuredness (6 items), attentiveness (4 items), fatigue (4 items) and serenity (3 items).
|
8 weeks, 12 weeks
|
|
Self-reported depressive symptomatology
Time Frame: 8 weeks, 12 weeks
|
Depressive symptomatology was assessed using the self-reported Center for Epidemiologic Studies Short Depression Scale (CESD-10).
Participants are asked to rate each symptom on a scale of rarely/none of time to (1) to all of the time (4).
|
8 weeks, 12 weeks
|
|
Self-reported social well-being
Time Frame: 8 weeks, 12 weeks
|
The 10-statement UCLA Loneliness Scale asked users to respond to the root statement "How often do you feel…." in conjunction with various statements describing social relationships; e.g., "How often do you feel as if nobody really understands you?" Responses were on a 4-point scale (1-often; 4=never)
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8 weeks, 12 weeks
|
|
Self-reported physical well-being
Time Frame: 8 weeks, 12 weeks
|
Eleven items were selected from the SF-36, a measure of functional status which contains 8 subscales.
Items from 2 of the subscales were included: bodily pain and general health perceptions.
Response scales were different for each of the subscales.
|
8 weeks, 12 weeks
|
|
Workplace outcomes
Time Frame: 8 weeks, 12 weeks
|
Absenteeism and presenteeism were assessed using the Workplace Outcomes Suite.
A score from a 9-item work engagement assessment including questions about hours of missed work due to absenteeism, lateness, leaving early, and questions about lost productivity due to lack of concentration or personal distractions involving disrupting phone calls, email.
|
8 weeks, 12 weeks
|
|
Users' perception of app usability
Time Frame: 8 weeks, 12 weeks
|
Treatment participants completed the System Usability Scale, a quantitative measure of program ease of use (Sauro, 2011).
The scale includes 10 items and 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).
|
8 weeks, 12 weeks
|
|
User satisfaction with the app experience
Time Frame: 8 weeks, 12 weeks
|
Users were asked 6 items pertaining to satisfaction and likelihood of continued use or recommendation of the Jauntly program specifically, on a 7-point scale (1=Not at all satisfied/likely; 7=Extremely satisfied/likely).
|
8 weeks, 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amy Birney, MPH, MCHES, Oregon Center for Applied Science
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102-2R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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