Psychological DistressNCT05199415
Fulfillment Center Study on Work, Health, and Wellbeing
A study testing Health and Well-being Committee in people with Psychological Distress and Psychological Well-being, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
This study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Psychological Well-being, Subjective Health
- What is being tested?
- Health and Well-being Committee
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,459 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 31 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All individuals, non-supervisory and supervisory, employed at the fulfillment centers, including temporary workers.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MIT Sloan School of Management
Cambridge, Massachusetts, 02142
About this study
Official title: Fulfillment Center Intervention Study as Part of The Harvard T.H. Chan School of Public Health Center for Work, Health and Wellbeing
This study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. The study centers on a cluster randomized trial evaluation of changes in workplace policies and practices in order to understand their impact on workers, families, and the firm but also utilize multi-method data to gain a better understanding of the stressors and sources of resilience for this growing, but understudied population of low-wage workers.
Read the detailed description
The goal of this study is to implement and test the feasibility of a participatory, integrated workplace intervention in fulfillment centers. The focal intervention is the launch of Health and Well-being Committees (HaWCs) in randomized fulfillment centers. The study aims related to the field experiment are to:
Aim #1: Evaluate an innovative participatory intervention aimed at improving health and well-being of non-supervisory workers in fulfillment centers to determine the intervention's efficacy and investigate possible mediation and proximate changes in the conditions of work
Aim #1a: Determine the efficacy of HaWCs in reducing psychological distress, improving key facets of positive psychological well-being and general self-reported health, and lowering levels of reported/unreported injuries.
Aim #1b: Investigate changes in key work conditions including voice, trust, support, safety climate, and workplace policies and practices, including how these proximate changes mediate outcomes
Aim #2: Conduct a process analysis of key contextual factors that support effective and integrated intervention implementation and sustained engagement.
Design and Randomization:
This study is a cluster-randomized trial with a staggered parallel research design. The investigators expect to randomize 21 fulfillment centers (N ≈ 200 workers per site) of a national e-commerce firm, with one additional site designated as a pilot site that will not be included in the randomization. Buildings will be stratified based on the technology used in the main job task of "picking," i.e., retrieving items from different warehouse locations to place into boxes. The firm uses three main picking technologies: conveyor, voice-to-cart, and robotics. Each technology affects the conditions of work and specific safety concerns (e.g., more muscular strain in voice-to-cart sites where workers pull heavy carts, more noise in conveyor sites, and more isolation and small repetitive arm motions in robotics sites).
Data collection involves three waves of survey data (baseline, 6-months, and 12-months). Additional data will be collected from the firm's administrative records and through interviews and focus groups to support the process analysis.
Intervention Delivery (0-12 months):
After randomization, intervention delivery will begin by meeting with management of each fulfillment center to orient them to the study. After the baseline survey, the HaWCs will be announced in treatment sites. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. The main task of these committees will be to identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then implement mitigating solutions and track outcomes. HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not usually labelled as health and safety policies.
The first four HaWC meetings will be facilitated by the research team. This first set of meetings will also serve as training for the co-chairs who will then take over leading the twice monthly HaWC meetings and coordinating HaWC action plans. The research team will have bi-monthly check-ins with the co-chairs to receive updates on HaWC activities and action plans, gather process data, and provide any needed support.
During this period, the 6-month and 12-month surveys will be administered in all sites.
Maintenance Phase (13-30 months):
Though the official experimental phase concludes at 12 months after baseline (and control sites may adopt the intervention after that), it is expected that HaWC activities will continue as committees implement action plans. During this period there will be less research team support, though technical assistance will be available to HaWCs upon request. The research team will conduct process data using HaWC meeting minutes, visual management tool photos, and periodic check-ins with co-chairs.
Data Analysis Plan:
In the experimental analysis for Aim 1, the investigators will estimate linear mixed-effects regression models for continuous outcomes, including the primary outcome of psychological distress and secondary outcomes such as positive psychological well-being and self-reported health. As a secondary analysis, the investigators will also model the change from baseline in order to directly control for baseline values of the outcomes of interest. However, because this model requires that subjects have baseline data, it will reduce the sample size and be included as a secondary analysis.
In the process analysis for Aim 2,t he investigators will answer research questions using qualitative analysis methods in which the investigators iterate ongoing data collection, analysis of each site as a case as well as comparisons across sites, and writing. The investigators will pursue an abductive analysis oriented to theory construction in which insights from the qualitative data surface in dialogue with existing theories and research as researchers focus on what is surprising, given existing theories, rather than building conclusions in a purely inductive process. Coding will be derived both deductively from themes and questions in the existing literature and inductively from the construction of additional categories as new themes and lines of inquiry emerge. Data analysis will be conducted using the qualitative software program Atlas.ti.
- Being tested
- Health and Well-being Committee
- Medical subject headings
- Psychological Well-Being, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Well-being CommitteeBehavioural
Health and Well-being Committees (HaWCs) will be introduced in treatment sites as a means to facilitate on-going problem identification and collaborative processes for developing action plans, implementing small-scale, site-based improvements. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. HaWCs will identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then design and implement mitigating solutions and track outcomes. As such, HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not labeled as health and safety policies.
| Study group | Role | What they receive |
|---|---|---|
| HaWC Intervention | Experimental | These are the buildings that are randomized to receive the intervention during the study period. Receives: Behavioral: Health and Well-being Committee |
| Control | No intervention | These are the buildings that are randomized to continue as normal (no intervention) during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
The frequency of non-specific psychological distress (e.g., feeling nervous, hopeless, restless or fidgety, depressed, worthless, and everything is an effort) experienced in the last 30 days. This outcome will be measured using the Kessler Distress Scale. Respondents report the frequency from 0 (none of the time) to 4 (all of the time). Items are summed to give a score between 0 and 24, with higher scores indicating higher levels of psychological distress.
Measured: 12 Months
Secondary outcomes (5)
Psychological well-being
Psychological well-being will be measured utilizing vitality items from the General Well-being Schedule. Respondents report the frequency of emotional vitality items in the last month on a scale from 0 (None of the time) to 5 (All of the time). The items are summed, with higher scores indicating greater levels of emotional vitality. The minimum score is 0 and the maximum score is 35. This measure has previously been linked with reduced risk of chronic disease and with better physical health outcomes.
Measured: 12 Months
Self-reported general health
A self-reported rating of general health using a singular item from the Short Form-36. Respondents will assess their own health as poor, fair, good, very good, or excellent.
Measured: 12 Months
Injuries and injuries reported to management
Self-reported injuries will be assessed in the questionnaire. Survey respondents will answer whether they experienced an injury at work in the last 12 months (a dichotomous variable Yes/No) that led to seeking medical advice or losing time from work. They will also be asked whether this injury was reported to management, and the reason for not reporting (if applicable).
Measured: 12 Months
Musculoskeletal pain
This is a self-report of musculoskeletal pain and severity in the last 3 months using a modified question from the Pro-Care Survey (NordicQ). Respondents will be asked whether they experienced pain (a dichotomous Yes/No variable) on 4 different body regions: back, shoulders or neck, hands/wrists/arms, and legs/knees/feet. If they respond yes to a body region, they will then be asked to rate the pain as mild, moderate, or severe.
Measured: 12 months
Sleep duration
Sleep duration (hours and minutes) in the last 30 days using an item from the Pittsburgh Sleep Quality Index.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start12 Jul 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (117)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Erin L Kelly, Phd, Principal investigator, MIT Sloan School of Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199415
- Sponsor's protocol ID
- 2008000224
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For the Fulfillment Center Intervention Study, administrative data are made available through a data use agreement with the firm; therefore, the investigators will be unable to make these data publicly available. Additionally, qualitative data will not be made public as it may be impossible to adequately de-identify these elements because of site-specific details and reflections in the interviews and focus groups. To protect confidentiality of these nested data (with employee survey responses nested in work sites), de-identified survey data will be available to researchers through a restricted data access process.
Publications
U.S. Bureau of Labor Statistics. One-Screen Data Search [Internet]. 2020. Available rom: https://data.bls.gov/PDQWeb/ce
Gutelius B, Theodore N. The future of warehouse work: technological change in the U.S. logistics industry. UC Berkeley Labor Center and Working Partnerships USA [Internet]. 2019;76. Available from: http://laborcenter.berkeley.edu/future-of-warehouse-work/
Abbott S, Gould-Werth A. Unboxing scheduling practices for U.S. warehouse workers: Lessons from a research advocacy roundtable. Washington Center for Equitable Growth [Internet]. 2020;30. Available from: https://equitablegrowth.org/research-paper/unboxing-scheduling-practices-for-u-s-warehouse-workers/
Guendelsberger E. On the clock: what low-wage work did to me and how it drives America insane. New York: Little, Brown and Company; 2019.
Berkman LF, Kawachi I, Theorell T. Working conditions and health. Social epidemiology [Internet]. 2nd ed. New York, NY: Oxford University Press, Incorporated; 2014 [cited 2020 Oct 21]. p. 640. Available from: http://ebookcentral.proquest.com/lib/harvard-ebooks/detail.action?docID=1784097
Joyce S, Modini M, Christensen H, Mykletun A, Bryant R, Mitchell PB, Harvey SB. Workplace interventions for common mental disorders: a systematic meta-review. Psychol Med. 2016 Mar;46(4):683-97. doi: 10.1017/S0033291715002408. Epub 2015 Dec 1.
PubMed 26620157Theorell T, Hammarstrom A, Aronsson G, Traskman Bendz L, Grape T, Hogstedt C, Marteinsdottir I, Skoog I, Hall C. A systematic review including meta-analysis of work environment and depressive symptoms. BMC Public Health. 2015 Aug 1;15:738. doi: 10.1186/s12889-015-1954-4.
PubMed 26232123Bannai A, Tamakoshi A. The association between long working hours and health: a systematic review of epidemiological evidence. Scand J Work Environ Health. 2014 Jan;40(1):5-18. doi: 10.5271/sjweh.3388. Epub 2013 Oct 7.
PubMed 24100465Ganster DC, Rosen CC, Fisher GG. Long working hours and well-being: what we know, what we do not know, and what we need to know. J Bus Psychol. 2018 Feb;33(1):25-39.
Nijp HH, Beckers DG, Geurts SA, Tucker P, Kompier MA. Systematic review on the association between employee worktime control and work-non-work balance, health and well-being, and job-related outcomes. Scand J Work Environ Health. 2012 Jul;38(4):299-313. doi: 10.5271/sjweh.3307. Epub 2012 Jun 6.
PubMed 22678492Schneider D, Harknett K. Consequences of Routine Work-Schedule Instability for Worker Health and Well-Being. Am Sociol Rev. 2019 Feb 1;84(1):82-114. doi: 10.1177/0003122418823184.
PubMed 33311716Evans W. Inside one of Amazon's hardest-hit warehouses: 'Why aren't we closing the building?' [Internet]. Reveal. 2020. Available from: https://revealnews.org/article/inside-one-of-amazons-hardest-hit-warehouses-why-arent-we-closing-the-building/
Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
PubMed 12214795Kubzansky LD, Boehm JK, Segerstrom SC. Positive psychological functioning and the biology of health: positive psychology and biology. Social and Personality Psychology Compass. 2015 Dec;9(12):645-660.
Kubzansky LD, Winning A. Mental disorders and the emergence of physical disorders. In: Koenen KC, Rudenstine S, Susser E, Galea S, editors. A life course approach to mental disorders. Oxford, U.K.: Oxford University Press; 2013. p. 291-304.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fulfillment Center Intervention Study as Part of The Harvard T.H. Chan School of Public Health Center for Work, Health and Wellbeing
- ClinicalTrials.gov ID
- NCT05199415
- Acronym / sponsor ID
- 2008000224
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,459 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 20 Jan 2022 (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 study seeks to evaluate how work conditions affect workers' health and well-being, job attitudes and decisions on the job, and key organizational outcomes. This study is being carried out in partnership with a national retailer's e-commerce division. The study centers on a cluster randomized trial evaluation of changes in workplace policies and practices in order to understand their impact on workers, families, and the firm but also utilize multi-method data to gain a better understanding of the stressors and sources of resilience for this growing, but understudied population of low-wage workers.
Detailed description
The goal of this study is to implement and test the feasibility of a participatory, integrated workplace intervention in fulfillment centers. The focal intervention is the launch of Health and Well-being Committees (HaWCs) in randomized fulfillment centers. The study aims related to the field experiment are to:
Aim #1: Evaluate an innovative participatory intervention aimed at improving health and well-being of non-supervisory workers in fulfillment centers to determine the intervention's efficacy and investigate possible mediation and proximate changes in the conditions of work
Aim #1a: Determine the efficacy of HaWCs in reducing psychological distress, improving key facets of positive psychological well-being and general self-reported health, and lowering levels of reported/unreported injuries.
Aim #1b: Investigate changes in key work conditions including voice, trust, support, safety climate, and workplace policies and practices, including how these proximate changes mediate outcomes
Aim #2: Conduct a process analysis of key contextual factors that support effective and integrated intervention implementation and sustained engagement.
Design and Randomization:
This study is a cluster-randomized trial with a staggered parallel research design. The investigators expect to randomize 21 fulfillment centers (N ≈ 200 workers per site) of a national e-commerce firm, with one additional site designated as a pilot site that will not be included in the randomization. Buildings will be stratified based on the technology used in the main job task of "picking," i.e., retrieving items from different warehouse locations to place into boxes. The firm uses three main picking technologies: conveyor, voice-to-cart, and robotics. Each technology affects the conditions of work and specific safety concerns (e.g., more muscular strain in voice-to-cart sites where workers pull heavy carts, more noise in conveyor sites, and more isolation and small repetitive arm motions in robotics sites).
Data collection involves three waves of survey data (baseline, 6-months, and 12-months). Additional data will be collected from the firm's administrative records and through interviews and focus groups to support the process analysis.
Intervention Delivery (0-12 months):
After randomization, intervention delivery will begin by meeting with management of each fulfillment center to orient them to the study. After the baseline survey, the HaWCs will be announced in treatment sites. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. The main task of these committees will be to identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then implement mitigating solutions and track outcomes. HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not usually labelled as health and safety policies.
The first four HaWC meetings will be facilitated by the research team. This first set of meetings will also serve as training for the co-chairs who will then take over leading the twice monthly HaWC meetings and coordinating HaWC action plans. The research team will have bi-monthly check-ins with the co-chairs to receive updates on HaWC activities and action plans, gather process data, and provide any needed support.
During this period, the 6-month and 12-month surveys will be administered in all sites.
Maintenance Phase (13-30 months):
Though the official experimental phase concludes at 12 months after baseline (and control sites may adopt the intervention after that), it is expected that HaWC activities will continue as committees implement action plans. During this period there will be less research team support, though technical assistance will be available to HaWCs upon request. The research team will conduct process data using HaWC meeting minutes, visual management tool photos, and periodic check-ins with co-chairs.
Data Analysis Plan:
In the experimental analysis for Aim 1, the investigators will estimate linear mixed-effects regression models for continuous outcomes, including the primary outcome of psychological distress and secondary outcomes such as positive psychological well-being and self-reported health. As a secondary analysis, the investigators will also model the change from baseline in order to directly control for baseline values of the outcomes of interest. However, because this model requires that subjects have baseline data, it will reduce the sample size and be included as a secondary analysis.
In the process analysis for Aim 2,t he investigators will answer research questions using qualitative analysis methods in which the investigators iterate ongoing data collection, analysis of each site as a case as well as comparisons across sites, and writing. The investigators will pursue an abductive analysis oriented to theory construction in which insights from the qualitative data surface in dialogue with existing theories and research as researchers focus on what is surprising, given existing theories, rather than building conclusions in a purely inductive process. Coding will be derived both deductively from themes and questions in the existing literature and inductively from the construction of additional categories as new themes and lines of inquiry emerge. Data analysis will be conducted using the qualitative software program Atlas.ti.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HaWC Intervention | Experimental | Behavioral: Health and Well-being CommitteeThese are the buildings that are randomized to receive the intervention during the study period. |
| Control | No intervention | –These are the buildings that are randomized to continue as normal (no intervention) during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals, non-supervisory and supervisory, employed at the fulfillment centers, including temporary workers.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Health and Well-being CommitteeHealth and Well-being Committees (HaWCs) will be introduced in treatment sites as a means to facilitate on-going problem identification and collaborative processes for developing action plans, implementing small-scale, site-based improvements. HaWCs will involve 10-14 workers and frontline supervisors, with a worker and manager co-chair. HaWCs will identify challenges to safety, health, and well-being spanning physical hazards, COVID-19 protocols as relevant, other conditions of work (e.g., schedules, pace of work), and policies (e.g., absenteeism, performance management). They will then design and implement mitigating solutions and track outcomes. As such, HaWCs have a broader scope than traditional safety committees and will actively solicit worker voice regarding policies and practices that are not labeled as health and safety policies. | Behavioural | HaWC Intervention |
Primary outcome
Psychological Distress
Time frame: 12 Months
The frequency of non-specific psychological distress (e.g., feeling nervous, hopeless, restless or fidgety, depressed, worthless, and everything is an effort) experienced in the last 30 days. This outcome will be measured using the Kessler Distress Scale. Respondents report the frequency from 0 (none of the time) to 4 (all of the time). Items are summed to give a score between 0 and 24, with higher scores indicating higher levels of psychological distress.
5 secondary outcomes
Psychological well-being
Time frame: 12 Months
Self-reported general health
Time frame: 12 Months
Injuries and injuries reported to management
Time frame: 12 Months
Musculoskeletal pain
Time frame: 12 months
Sleep duration
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- BackgroundU.S. Bureau of Labor Statistics. One-Screen Data Search [Internet]. 2020. Available rom: https://data.bls.gov/PDQWeb/ce
- BackgroundGutelius B, Theodore N. The future of warehouse work: technological change in the U.S. logistics industry. UC Berkeley Labor Center and Working Partnerships USA [Internet]. 2019;76. Available from: http://laborcenter.berkeley.edu/future-of-warehouse-work/
- BackgroundAbbott S, Gould-Werth A. Unboxing scheduling practices for U.S. warehouse workers: Lessons from a research advocacy roundtable. Washington Center for Equitable Growth [Internet]. 2020;30. Available from: https://equitablegrowth.org/research-paper/unboxing-scheduling-practices-for-u-s-warehouse-workers/
- BackgroundGuendelsberger E. On the clock: what low-wage work did to me and how it drives America insane. New York: Little, Brown and Company; 2019.
- BackgroundBerkman LF, Kawachi I, Theorell T. Working conditions and health. Social epidemiology [Internet]. 2nd ed. New York, NY: Oxford University Press, Incorporated; 2014 [cited 2020 Oct 21]. p. 640. Available from: http://ebookcentral.proquest.com/lib/harvard-ebooks/detail.action?docID=1784097
- Background: PubMed 26620157Joyce S, Modini M, Christensen H, Mykletun A, Bryant R, Mitchell PB, Harvey SB. Workplace interventions for common mental disorders: a systematic meta-review. Psychol Med. 2016 Mar;46(4):683-97. doi: 10.1017/S0033291715002408. Epub 2015 Dec 1.
- Background: PubMed 26232123Theorell T, Hammarstrom A, Aronsson G, Traskman Bendz L, Grape T, Hogstedt C, Marteinsdottir I, Skoog I, Hall C. A systematic review including meta-analysis of work environment and depressive symptoms. BMC Public Health. 2015 Aug 1;15:738. doi: 10.1186/s12889-015-1954-4.
- Background: PubMed 24100465Bannai A, Tamakoshi A. The association between long working hours and health: a systematic review of epidemiological evidence. Scand J Work Environ Health. 2014 Jan;40(1):5-18. doi: 10.5271/sjweh.3388. Epub 2013 Oct 7.
- BackgroundGanster DC, Rosen CC, Fisher GG. Long working hours and well-being: what we know, what we do not know, and what we need to know. J Bus Psychol. 2018 Feb;33(1):25-39.
- Background: PubMed 22678492Nijp HH, Beckers DG, Geurts SA, Tucker P, Kompier MA. Systematic review on the association between employee worktime control and work-non-work balance, health and well-being, and job-related outcomes. Scand J Work Environ Health. 2012 Jul;38(4):299-313. doi: 10.5271/sjweh.3307. Epub 2012 Jun 6.
- Background: PubMed 33311716Schneider D, Harknett K. Consequences of Routine Work-Schedule Instability for Worker Health and Well-Being. Am Sociol Rev. 2019 Feb 1;84(1):82-114. doi: 10.1177/0003122418823184.
- BackgroundEvans W. Inside one of Amazon's hardest-hit warehouses: 'Why aren't we closing the building?' [Internet]. Reveal. 2020. Available from: https://revealnews.org/article/inside-one-of-amazons-hardest-hit-warehouses-why-arent-we-closing-the-building/
- Individual participant dataSharing planned: Yes. For the Fulfillment Center Intervention Study, administrative data are made available through a data use agreement with the firm; therefore, the investigators will be unable to make these data publicly available. Additionally, qualitative data will not be made public as it may be impossible to adequately de-identify these elements because of site-specific details and reflections in the interviews and focus groups. To protect confidentiality of these nested data (with employee survey responses nested in work sites), de-identified survey data will be available to researchers through a restricted data access process.
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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.
Erin L Kelly, Phd principal investigator
MIT Sloan School of Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and Well-being Committee in people with Psychological Distress and Psychological Well-being, run by Massachusetts Institute of Technology 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace DeHorn, MSW (574-299-6862, gdehorn@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: 12 Months). 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 NCT05199415, which also lists 117 linked publications.
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 20 Mar 2023.