Job Related StressNCT04676698
Three Good Things 2020: a Brief Text-based Wellness Intervention
A study testing Three Good Things in people with Job Related Stress, run by University of Michigan at 1 site in United States.
Trial summary
This trial will be open to all Michigan Medicine Department of Family Medicine faculty, resident, or staff. The intervention will consist of asking participants the "3 Good Things" based on positive psychology theory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Job Related Stress
- What is being tested?
- Three Good Things
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 28 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Faculty, resident, or staff in the Michigan Medicine (MM) Department of Family Medicine
Who cannot join
- Not a member of Family Medicine at MM
Trial locations and contacts
1 site in 1 country.
About this study
This trial will be open to all Michigan Medicine Department of Family Medicine faculty, resident, or staff.
The intervention will consist of asking participants the "3 Good Things" based on positive psychology theory. Participants will be asked to list three things that went well that day and to consider their role in these outcomes. Pre and post surveys will be completed to evaluate this intervention.
At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction.
- Conditions
- Job Related Stress
- Being tested
- Three Good Things, Wait list control arm and then Three Good Things
- Keywords
- Satisfaction, Depression
- Medical subject headings
- Occupational Stress, Personal Satisfaction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Good ThingsBehavioural
The treatment phase will last 3 weeks. However, participants will complete surveys at baseline and up to 6 months. At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction.
Wait list control arm and then Three Good ThingsBehavioural
Surveys will be completed for 3 months prior to treatment and then after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Three Good Things | Experimental | Three times weekly for three weeks, participants will receive a text-based survey asking them to type or dictate "three good things." Receives: Behavioral: Three Good Things |
| Waitlist Control Arm then Three Good Things | Active comparator | Participants will have surveys in the waiting period for 3 months and then be crossed over to the treatment arm Three Good Things. Receives: Behavioral: Wait list control arm and then Three Good Things |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Positive and Negative Affect Schedule (PANAS-SF) between the intervention and control group
This is a 10 item survey to measure positive and negative affect. Responses include; very slightly or not at all, a little, quite a bit, and extremely. Higher scores of Positive Affect (PA) subscale represent higher positive affect higher scores of Negative affect (NA) subscale represent higher negative affect.
Measured: Pre-Treatment (baseline), up to 6 months
Secondary outcomes (6)
Change in self-reported physical health
This is a 1 question item to assess participants physical health ( 1=Excellent 2=good 3=fair 4=poor).
Measured: Pre-Treatment (baseline), up to 6 months
Change in self-reported mental health
This is a 1 question item to assess participants mental health ( 1=Excellent 2=good 3=fair 4=poor).
Measured: Pre-Treatment (baseline), up to 6 months
Change in Gratitude using the Gratitude Adjective Checklist (GAC)
The GAC is a 3-item self-report measure of state gratitude in which participants select, (1) A little (2) Moderately, Quite a bit (4), and Extremely (5).The total score on GAC ranges from 3 to 15, with higher score indicating greater state gratitude.
Measured: Pre-Treatment (baseline), up to 6 months
Change in depression using the Patient Health Questionnaire 9-item (PHQ-9) score
PHQ-9 scores reflect depression severity. Participants will select responses that include 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Ranges in scores are from 0-27 (Scores: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe).
Measured: Pre-Treatment (baseline) to 6 months
Change in Satisfaction with Life Questionnaire
This is a 5 question questionnaire in which participants select from 7 responses that are given a 1-7 scale from strongly disagree to strongly agree. Scoring ranges from 5-35 where 20 = neutral (the higher the score the more satisfaction).
Measured: Pre-Treatment (baseline), up to 6 months
Change in the Hope Scale
This is a 12 item questionnaire in which participants select from answers that include 1=definitely false 2=mostly false 3=mostly true 4=definitely true.
Scores range from 12-48 with higher scores indicating greater hope.
Measured: Pre-Treatment (baseline), up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start3 Feb 2021
- Primary completion28 Aug 2021
- Study completion28 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Job Related StressStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Gold, University of Michigan
- Investigators
- Katherine Gold, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676698
- Sponsor's protocol ID
- HUM00188399
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Good Things 2020: a Brief Text-based Wellness Intervention
- ClinicalTrials.gov ID
- NCT04676698
- Acronym / sponsor ID
- HUM00188399
- Conditions
- Job Related Stress
- Keywords
- Satisfaction, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 28 Aug 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- 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.
This trial will be open to all Michigan Medicine Department of Family Medicine faculty, resident, or staff.
The intervention will consist of asking participants the "3 Good Things" based on positive psychology theory. Participants will be asked to list three things that went well that day and to consider their role in these outcomes. Pre and post surveys will be completed to evaluate this intervention.
At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three Good Things | Experimental | Behavioral: Three Good ThingsThree times weekly for three weeks, participants will receive a text-based survey asking them to type or dictate "three good things." |
| Waitlist Control Arm then Three Good Things | Active comparator | Behavioral: Wait list control arm and then Three Good ThingsParticipants will have surveys in the waiting period for 3 months and then be crossed over to the treatment arm Three Good Things. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Faculty, resident, or staff in the Michigan Medicine (MM) Department of Family Medicine
Key exclusion criteria (1 listed)
- Not a member of Family Medicine at MM
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 |
|---|---|---|
| Three Good ThingsThe treatment phase will last 3 weeks. However, participants will complete surveys at baseline and up to 6 months. At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction. | Behavioural | Three Good Things |
| Wait list control arm and then Three Good ThingsSurveys will be completed for 3 months prior to treatment and then after treatment. | Behavioural | Waitlist Control Arm then Three Good Things |
Primary outcome
Change in the Positive and Negative Affect Schedule (PANAS-SF) between the intervention and control group
Time frame: Pre-Treatment (baseline), up to 6 months
This is a 10 item survey to measure positive and negative affect. Responses include; very slightly or not at all, a little, quite a bit, and extremely. Higher scores of Positive Affect (PA) subscale represent higher positive affect higher scores of Negative affect (NA) subscale represent higher negative affect.
6 secondary outcomes
Change in self-reported physical health
Time frame: Pre-Treatment (baseline), up to 6 months
Change in self-reported mental health
Time frame: Pre-Treatment (baseline), up to 6 months
Change in Gratitude using the Gratitude Adjective Checklist (GAC)
Time frame: Pre-Treatment (baseline), up to 6 months
Change in depression using the Patient Health Questionnaire 9-item (PHQ-9) score
Time frame: Pre-Treatment (baseline) to 6 months
Change in Satisfaction with Life Questionnaire
Time frame: Pre-Treatment (baseline), up to 6 months
Change in the Hope Scale
Time frame: Pre-Treatment (baseline), up to 6 months
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 3 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Katherine Gold, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three Good Things in people with Job Related Stress, run by University of Michigan 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 1 inclusion and 1 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 3 Dec 2021. 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.
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?
Change in the Positive and Negative Affect Schedule (PANAS-SF) between the intervention and control group (time frame: Pre-Treatment (baseline), up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2021.