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StressPhase 2EmotionsNCT02346591

Mobile-Web Emotion Self-management Tool

A Phase 2 study testing Jauntly and Online stress management information in people with Stress and Depression, run by Oregon Center for Applied Science, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators developed a responsive mobile-web app, "Jauntly," which was designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Depression
What is being tested?
Jauntly and Online stress management information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteUnited States
Study dates
Feb 2013to Nov 2013
Phase
Phase 2
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • High level of self-reported grief
  • High level of self-reported depression (PHQ-2)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Center for Applied Science

    Eugene, Oregon, 97401

Other trials in United States

About this study

Official title: Emotion Management Training: An Innovative Stress Reduction Program

The investigators developed a responsive mobile-web app, "Jauntly," which was designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience. The app's 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. Program content was adapted from a variety of stress-relevant research areas including health psychology/psychosomatic medicine, social/personality psychology, positive psychology, and clinical psychology.

Read the 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.

Conditions
Stress, Depression
Being tested
Jauntly, Online stress management information
Keywords
Positive psychology, Wellbeing, Stress reduction, Relaxation, Gratitude, Mobile app, Intervention, Altruism, Psychological well-being, Social well-being, Physical well-being, Workplace engagement
Medical subject headings
Depression, Altruism, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JauntlyBehavioural

    Mobile app designed to encourage positive emotion-enhancing and stress reduction activities.

  • Online stress management informationBehavioural

    Online educational information about stress management

Study groups in NCT02346591
Study groupRoleWhat they receive
JauntlyExperimentalMobile 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.
Receives: Behavioral: Jauntly
Online stress management informationActive comparatorThe control participants were emailed links to vetted online information about stress and encouraged to visit the websites.
Receives: Behavioral: Online stress management information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall perceived stress

    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.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Psychological well-being assessed as positive and negative affect

    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).

    Measured: 8 weeks, 12 weeks

  2. Self-reported depressive symptomatology

    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).

    Measured: 8 weeks, 12 weeks

  3. Self-reported social well-being

    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)

    Measured: 8 weeks, 12 weeks

  4. Self-reported physical well-being

    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.

    Measured: 8 weeks, 12 weeks

  5. Workplace outcomes

    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.

    Measured: 8 weeks, 12 weeks

  6. Users' perception of app usability

    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).

    Measured: 8 weeks, 12 weeks

  7. User satisfaction with the app experience

    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).

    Measured: 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346591
Sponsor's protocol ID
102-2R
Acronym
Emotions
Status last verified
Jan 2015
First submitted
21 Jan 2015
Last updated
27 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jauntly and Online stress management information in people with Stress and Depression, run by Oregon Center for Applied Science, Inc. at 1 site in United States.

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 5 inclusion and 2 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Overall perceived stress (time frame: 12 weeks). 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 NCT02346591.

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 27 Jan 2015.

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