BurnoutNCT05806112
Effectiveness of Interventions to Improve Resiliency & Burnout in Behavioral Health Residential Staff
A study testing Resiliency Training, Task Sharing and Workplace Improvement Learning Collaborative in people with Burnout and Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Stress, Coping Skills
- What is being tested?
- Resiliency Training, Task Sharing and Workplace Improvement Learning Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Permanent-salary staff working in participating group homes
Who cannot join
- Temp staff and per diem workers
- Staff working in group homes not included in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are:
- Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors?
- Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents?
- What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC?
Read more
Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews.
Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.
Read the detailed description
This study involves group homes for adults (age 18+) with serious mental illness (DSM-V Diagnosis of Axis-I Mental Illness with persistent functional impairment) and group homes for adults with developmental and intellectual disabilities operated by public-sector community-based human service organizations. Approximately n=180 group homes operated by two human services organizations in Massachusetts (Vinfen and Bay Cove Human Services) with approximately 900 residential care workers (RCWs) will be included in this study.
To test whether site-level Integrated Resiliency Training and Task Sharing (IRTTS) is superior to an organization-level Workplace Improvement Learning Collaborative (WILC) in improving RCW-level and group-home-level outcomes, researchers will conduct a cluster randomized trial randomizing n=180 congregate care homes to either IRTTS (n=90 homes) or WILC (n=90 homes) in three 18-month phases over the study period (60 homes enrolled per phase). Note: the unit of randomization is group home, not individual RCW. Cluster randomization is adopted as the interventions are system-level interventions delivered to groups of individuals in each home. As IRTTS consists of training RCWs in group-based resiliency, researchers will provide training to approximately 5 RCWs in each group home and evaluate outcomes for 90 group homes and approximately 450 RCWs assigned to IRTTS (30 IRTTS group homes and 150 IRTTS RCWs in each of three phases of the implementation). WILC consists of a learning collaborative approach involving group home leaders. For the n=90 WILC group homes, researchers will involve n=90 group home leaders and will evaluate the impact on group home-level outcomes for the n=90 group homes on approximately 450 RCWs assigned to WILC (30 WILC group homes and 150 WILC RCWs in each of the three phases of implementation). The project will take place over four years.
- Conditions
- Burnout, Stress, Coping Skills, Depression, Anxiety, Physical Inactivity
- Being tested
- Resiliency Training, Task Sharing, Workplace Improvement Learning Collaborative
- Keywords
- group home, resiliency, residential care worker, burnout, turnover
- Medical subject headings
- Burnout, Psychological, Depression, Anxiety Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiliency TrainingBehavioural
Also called The Stress Management and Resiliency Training: Relaxation Response Resiliency Program, SMART-3RP
The Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART-3RP) has been shown to be effective in improving resilience and reducing distress among individuals across different populations and settings. The SMART-3RP enhances resilience by 1) teaching tools to elicit the relaxation response (RR) to offset negative effects of chronic stress; 2) improving stress management and awareness; and 3) promoting growth enhancement and agency to effect positive change. It blends stress coping principles from mind-body, cognitive-behavioral, and positive psychology theory to teach skills to advance each of these resiliency processes. The training will be delivered in six 50-minute virtual group sessions with 2 optional "booster sessions" available for those who desire additional sessions to further consolidate the core resiliency skills.
Task SharingBehavioural
Task Sharing is a process involving health care workers in partnership with others in which workers retain many of their primary tasks, but some tasks are completed collaboratively or by other workers or volunteers in a shared effort. Study coaches will work with the group home directors and RCWs to identify shared tasks that may be conducted by peers or resident volunteers by task co-assignment with supervision and support. Task co-assignments will be discussed in routine house meetings occurring on a weekly basis and incorporated into a jointly developed "house plan". The house plan will engage staff and residents to identify shared activities to reduce the burden on RCWs through task co-assignment and team-based efforts aimed at tasks that create unnecessary burden and stress for RCWs, yet do not require RCWs to complete them.
Workplace Improvement Learning CollaborativeBehavioural
The Workplace Improvement Learning Collaborative (WILC) consists of identifying major sources of RCW burnout across the system and then instituting an organizational (agency-wide) measure to address the identified sources of burnout by restructuring tasks (e.g., reducing administrative burdens, increasing workflow efficiencies) through a virtual earning collaborative with group home leaders. Learning collaboratives commonly use a structured framework within which teams learn about research and best practices, apply quality-improvement methods, and exchange their experiences in making improvements with the widespread use of such collaboratives. Program Directors will participate in a learning collaborative facilitated by trained and certified study coaches to identify and collaboratively develop and implement effective strategies to address root causes of RCW burnout across group homes and program directors assigned to the WILC intervention.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Resiliency Training and Task Sharing | Experimental | A multi-component intervention combining resiliency training and task sharing implemented at the site-level (microsystem). Receives: Behavioral: Resiliency Training; Behavioral: Task Sharing |
| Workplace Improvement Learning Collaborative | Experimental | A workplace improvement learning collaborative implemented at the organization level (mesosystem). Receives: Behavioral: Workplace Improvement Learning Collaborative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience (baseline)
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
Measured: Baseline
Resilience (3-month follow-up)
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
Measured: 3-months
Resilience (12-month follow-up)
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
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 posted10 Apr 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Vinfen, Bay Cove Human Services
- Responsible party
- Principal investigator, Stephen Bartels, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806112
- Sponsor's protocol ID
- 2023P000476
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interventions to Improve Resiliency & Burnout in Behavioral Health Residential Staff
- ClinicalTrials.gov ID
- NCT05806112
- Acronym / sponsor ID
- 2023P000476
- Conditions
- Burnout, Stress, Coping Skills, Depression, Anxiety, Physical Inactivity
- Keywords
- group home, resiliency, residential care worker, burnout, turnover
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Vinfen, Bay Cove Human Services
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 10 Apr 2023 (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.
The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are:
- Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors?
- Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents?
- What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC?
Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews.
Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.
Detailed description
This study involves group homes for adults (age 18+) with serious mental illness (DSM-V Diagnosis of Axis-I Mental Illness with persistent functional impairment) and group homes for adults with developmental and intellectual disabilities operated by public-sector community-based human service organizations. Approximately n=180 group homes operated by two human services organizations in Massachusetts (Vinfen and Bay Cove Human Services) with approximately 900 residential care workers (RCWs) will be included in this study.
To test whether site-level Integrated Resiliency Training and Task Sharing (IRTTS) is superior to an organization-level Workplace Improvement Learning Collaborative (WILC) in improving RCW-level and group-home-level outcomes, researchers will conduct a cluster randomized trial randomizing n=180 congregate care homes to either IRTTS (n=90 homes) or WILC (n=90 homes) in three 18-month phases over the study period (60 homes enrolled per phase). Note: the unit of randomization is group home, not individual RCW. Cluster randomization is adopted as the interventions are system-level interventions delivered to groups of individuals in each home. As IRTTS consists of training RCWs in group-based resiliency, researchers will provide training to approximately 5 RCWs in each group home and evaluate outcomes for 90 group homes and approximately 450 RCWs assigned to IRTTS (30 IRTTS group homes and 150 IRTTS RCWs in each of three phases of the implementation). WILC consists of a learning collaborative approach involving group home leaders. For the n=90 WILC group homes, researchers will involve n=90 group home leaders and will evaluate the impact on group home-level outcomes for the n=90 group homes on approximately 450 RCWs assigned to WILC (30 WILC group homes and 150 WILC RCWs in each of the three phases of implementation). The project will take place over four years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Resiliency Training and Task Sharing | Experimental | Behavioral: Resiliency Training, Behavioral: Task SharingA multi-component intervention combining resiliency training and task sharing implemented at the site-level (microsystem). |
| Workplace Improvement Learning Collaborative | Experimental | Behavioral: Workplace Improvement Learning CollaborativeA workplace improvement learning collaborative implemented at the organization level (mesosystem). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent-salary staff working in participating group homes
Key exclusion criteria (2 listed)
- Temp staff and per diem workers
- Staff working in group homes not included in this study
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 |
|---|---|---|
| Resiliency TrainingAlso: The Stress Management and Resiliency Training: Relaxation Response Resiliency Program, SMART-3RPThe Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART-3RP) has been shown to be effective in improving resilience and reducing distress among individuals across different populations and settings. The SMART-3RP enhances resilience by 1) teaching tools to elicit the relaxation response (RR) to offset negative effects of chronic stress; 2) improving stress management and awareness; and 3) promoting growth enhancement and agency to effect positive change. It blends stress coping principles from mind-body, cognitive-behavioral, and positive psychology theory to teach skills to advance each of these resiliency processes. The training will be delivered in six 50-minute virtual group sessions with 2 optional "booster sessions" available for those who desire additional sessions to further consolidate the core resiliency skills. | Behavioural | Integrated Resiliency Training and Task Sharing |
| Task SharingTask Sharing is a process involving health care workers in partnership with others in which workers retain many of their primary tasks, but some tasks are completed collaboratively or by other workers or volunteers in a shared effort. Study coaches will work with the group home directors and RCWs to identify shared tasks that may be conducted by peers or resident volunteers by task co-assignment with supervision and support. Task co-assignments will be discussed in routine house meetings occurring on a weekly basis and incorporated into a jointly developed "house plan". The house plan will engage staff and residents to identify shared activities to reduce the burden on RCWs through task co-assignment and team-based efforts aimed at tasks that create unnecessary burden and stress for RCWs, yet do not require RCWs to complete them. | Behavioural | Integrated Resiliency Training and Task Sharing |
| Workplace Improvement Learning CollaborativeThe Workplace Improvement Learning Collaborative (WILC) consists of identifying major sources of RCW burnout across the system and then instituting an organizational (agency-wide) measure to address the identified sources of burnout by restructuring tasks (e.g., reducing administrative burdens, increasing workflow efficiencies) through a virtual earning collaborative with group home leaders. Learning collaboratives commonly use a structured framework within which teams learn about research and best practices, apply quality-improvement methods, and exchange their experiences in making improvements with the widespread use of such collaboratives. Program Directors will participate in a learning collaborative facilitated by trained and certified study coaches to identify and collaboratively develop and implement effective strategies to address root causes of RCW burnout across group homes and program directors assigned to the WILC intervention. | Behavioural | Workplace Improvement Learning Collaborative |
Primary outcome
Resilience (baseline)
Time frame: Baseline
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
Resilience (3-month follow-up)
Time frame: 3-months
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
Resilience (12-month follow-up)
Time frame: 12-months
Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resiliency Training, Task Sharing and Workplace Improvement Learning Collaborative in people with Burnout and Stress, run by Massachusetts General Hospital 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 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: enrolling by invitation, as of the sponsor's last update on 10 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Resilience (baseline) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 10 Apr 2023.