Intervention 1: Resilience and Coping for Healthcare GroupNCT03722368
Health and Wellness in Healthcare Providers Post-disaster
A study testing RCHC and RCHC+ in people with Intervention 1: Resilience and Coping for Healthcare Group and Intervention 2: Resilience and Coping for Healthcare Plus Additional Services, run by University of Illinois at Urbana-Champaign at 2 sites in 2 countries.
Trial summary
The purpose of this evaluation is to understand the impact of mental health and psychosocial support (MHPS) programming that AmeriCares (a non-profit disaster response organization) is currently providing to healthcare and social service providers in Southeast Texas and Puerto Rico. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention 1: Resilience and Coping for Healthcare Group, Intervention 2: Resilience and Coping for Healthcare Plus Additional Services, Waitlist Control Group
- What is being tested?
- RCHC and RCHC+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2018to 30 Jun 2019
- 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
- Healthcare workers will be eligible for the study if they are:
- over 18 years of age at the time of admission into the study;
- speak and read English or Spanish;
- have been identified as having experienced Hurricane Harvey or Maria or providing care to people living in areas affected by the storms;
- are employed by a participating Community Health Center or partnering agency;
- participate in AmeriCares MHPS programs.
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- Exclusion criteria: Healthcare workers will be excluded if they:
- do not meet the inclusion criteria, or
- do not give consent to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Evaluation of a Tiered Approach to Increase Well-Being in Healthcare and Social Service Providers in a Post-Disaster Context
The purpose of this evaluation is to understand the impact of mental health and psychosocial support (MHPS) programming that AmeriCares (a non-profit disaster response organization) is currently providing to healthcare and social service providers in Southeast Texas and Puerto Rico. The MHPS services are designed to provide skills to reduce stress, improve coping and reduce symptoms of burnout (compassion fatigue).
Read the detailed description
Health care and social service providers from disaster-affected communities are at heightened risk for emotional distress symptoms immediately after the event and over the longer-term recovery period. They provide care to others both physically and emotionally, while at the same time are often in the process of recovery and rebuilding their own lives. Health care providers, particularly those who work in safety net health centers, often serve high-need communities where incomes are lower, health issues are elevated, and health care is scarce.
Given the high risk for emotional distress symptoms for healthcare workers after a disaster, it is critical to offer services to help ease the stress during the hurricane recovery. This evaluation will examine the impact of Americares mental health and psychosocial (MHPS) programming on care providers in the short- and longterm recovery. The purpose of this evaluation is to understand the impact of mental health and psychosocial support (MHPS) programming that AmeriCares (a non-profit disaster response organization) is currently providing to healthcare and social service providers in Southeast Texas and Puerto Rico. The MHPS services are designed to provide skills to reduce stress, improve coping and reduce symptoms of burnout (compassion fatigue).
The study included naturalistic groups that will receive services from Americares based on the agencies needs.
They will include:
- A waitlisted control group who will receive services within 3-months after the study begins
- A group who will receive one specific workshop, known as RCHC (Resilience and Coping for the Healthcare Community)
- A group who will receive RCHC plus additional services (RCHC+)
The 3-hour RCHC intervention draws from existing literature and theory on effective psychosocial interventions and integrates the following components:
- An open interactive learning environment
- A safe environment for open communication
- Education and strategies to support highly stressed and/or traumatized patients.
- Psycho-education about stress and coping
- Planning for coping strategies
- Identification and referral to mental health resources The additional services will include wellness groups and psychoeducational training. The wellness groups include a variety of topics, designed to promote healthy living and empowerment. Each one-hour group will be facilitated by Americares staff and tailored to particular needs of the group. Topics may include but not limited to: Grief and loss, Stress management, Workplace wellness, Navigating support systems. The psychoeducational trainings provide healthcare workers with educational resources to support their patients in the aftermath of Harvey and recognize and respond to stress reactions. Training topics include: Psychological First Aid for Adults, Psychological First Aid for Children, The Brain, the Body and Trauma, Coping with Difficult Workplace Situations.
- Conditions
- Intervention 1: Resilience and Coping for Healthcare Group, Intervention 2: Resilience and Coping for Healthcare Plus Additional Services, Waitlist Control Group
- Being tested
- RCHC, RCHC+, Waitlist control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCHCBehavioural
The RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills.
RCHC+Behavioural
Also called Resilience and Coping for the Healthcare Community Plus additional Services
The RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills. This intervention group will also receive on-going support groups and one on one counseling as needed.
Waitlist controlOther
This group will served as the control group and will receive treatment as usual until the end of the study. At the end of the study they will have the opportunity to take part in the RCHC or RCHC+
| Study group | Role | What they receive |
|---|---|---|
| RCHC | Experimental | Participation in the Resilience and Coping of the Healthcare Community Intervention. Receives: Behavioral: RCHC |
| RCHC+ | Experimental | Participation in the Resilience and Coping of the Healthcare Community Intervention, support groups and one on one counseling. Receives: Behavioral: RCHC+ |
| Waitlist Control | Other | This group will receive treatment as usual and will be offered services once the study is complete. Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ProQol--Assessing change over time
The ProQOL 5 is a 30-item scale for measuring professional quality of life among people who work in the helping professions (Stamm, 2010). The tool measures the positive aspect of compassion satisfaction (the pleasure you derive from being able to do your work well), and the negative aspect of compassion fatigue, which is composed of two parts: burnout (exhaustion, frustration and anger) and secondary trauma (work-related secondary exposure to people who have experienced traumatic events).
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (5)
Social Provisions Scale--Assessing change over time
Subscales of the Social Provisions Scale (SPS) (Cutrona \& Russel, 1987) (8 items): Reliable Alliance (4), Guidance (4) For the purposes of our study, the instructions leading into the SPS were changed to restrict participants to thinking about co-workers. The measure asks respondents to rate the degree to which their social relationships are currently supplying each of the provisions. Each provision is assessed by four items, two that describe the presence and two that describe the absence of the provision. Respondents indicate on 4-point scales (ranging fromcompletely true to not at all true ) the extent to which each statement describes their current social relationships. For scoring purposes, the negative items are reversed and summed together with the positive items to form a score for each social provision. Reliability for the total support score in a previous study was .92, with reliabilities of the 4-item subscales ranging from .76 to .84 (Cutrona, Russell, \& Rose, 1986).
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Brief Resilience Scale--Assessing change over time
The brief resilience scale (BRS) was created to assess the ability to bounce back or recover from stress. The BRS has been tested and is reliable as a unitary construct. It is predictably related to personal characteristics, social relations, coping, and health in all samples. It was negatively related to anxiety, depression, negative affect, and physical symptoms when other resilience measures and optimism, social support.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Perceived Stress Scale (PSS) (10)--Assessing change over time
The PSS is a widely used measure of the degree to which situations in one's life are appraised as stressful (Cohen, Kessler, \& Underwood Gordon, 1994) .
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Impact of Events Scale-Revised--Assessing change over time
Six item screen derived from the PTSD Checklist-Civilian Version to help primary care settings screen for persons with possible PTSD symptoms. The six items evaluate reexperiencing, avoidance, and hyperarousal which are highly correlated with the PCL-C. The full checklist was studied and utilized to screen for PTSD in countries such as China , Armenia, and Nepal.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Brief Cope--Assessing change over time
The Brief COPE measures 14 identified coping responses: Self-distraction, Active coping, Denial, Substance use, use of instrumental support, use of emotional support, behavioral disengagement, venting, positive reframing, acceptance, planning, humor, religion, and Self-blame. It represents a way to rapidly measure coping responses because it is a short 28-item self-report questionnaire with two items for each of the measured coping strategies.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Jul 2018
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention 1: Resilience and Coping for Healthcare GroupStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Americares, Louisiana State University Health Sciences Center in New Orleans, Colorado State University
- Responsible party
- Principal investigator, Tara Powell, University of Illinois at Urbana-Champaign
- Investigators
- Tara Powell, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722368
- Sponsor's protocol ID
- 18699
- Status last verified
- Aug 2019
- First submitted
- 16 Oct 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Tiered Approach to Increase Well-Being in Healthcare and Social Service Providers in a Post-Disaster Context
- ClinicalTrials.gov ID
- NCT03722368
- Acronym / sponsor ID
- 18699
- Conditions
- Intervention 1: Resilience and Coping for Healthcare Group, Intervention 2: Resilience and Coping for Healthcare Plus Additional Services, Waitlist Control Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Americares, Louisiana State University Health Sciences Center in New Orleans, Colorado State University
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Oct 2018 (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 purpose of this evaluation is to understand the impact of mental health and psychosocial support (MHPS) programming that AmeriCares (a non-profit disaster response organization) is currently providing to healthcare and social service providers in Southeast Texas and Puerto Rico. The MHPS services are designed to provide skills to reduce stress, improve coping and reduce symptoms of burnout (compassion fatigue).
Detailed description
Health care and social service providers from disaster-affected communities are at heightened risk for emotional distress symptoms immediately after the event and over the longer-term recovery period. They provide care to others both physically and emotionally, while at the same time are often in the process of recovery and rebuilding their own lives. Health care providers, particularly those who work in safety net health centers, often serve high-need communities where incomes are lower, health issues are elevated, and health care is scarce.
Given the high risk for emotional distress symptoms for healthcare workers after a disaster, it is critical to offer services to help ease the stress during the hurricane recovery. This evaluation will examine the impact of Americares mental health and psychosocial (MHPS) programming on care providers in the short- and longterm recovery. The purpose of this evaluation is to understand the impact of mental health and psychosocial support (MHPS) programming that AmeriCares (a non-profit disaster response organization) is currently providing to healthcare and social service providers in Southeast Texas and Puerto Rico. The MHPS services are designed to provide skills to reduce stress, improve coping and reduce symptoms of burnout (compassion fatigue).
The study included naturalistic groups that will receive services from Americares based on the agencies needs.
They will include:
- A waitlisted control group who will receive services within 3-months after the study begins
- A group who will receive one specific workshop, known as RCHC (Resilience and Coping for the Healthcare Community)
- A group who will receive RCHC plus additional services (RCHC+)
The 3-hour RCHC intervention draws from existing literature and theory on effective psychosocial interventions and integrates the following components:
- An open interactive learning environment
- A safe environment for open communication
- Education and strategies to support highly stressed and/or traumatized patients.
- Psycho-education about stress and coping
- Planning for coping strategies
- Identification and referral to mental health resources The additional services will include wellness groups and psychoeducational training. The wellness groups include a variety of topics, designed to promote healthy living and empowerment. Each one-hour group will be facilitated by Americares staff and tailored to particular needs of the group. Topics may include but not limited to: Grief and loss, Stress management, Workplace wellness, Navigating support systems. The psychoeducational trainings provide healthcare workers with educational resources to support their patients in the aftermath of Harvey and recognize and respond to stress reactions. Training topics include: Psychological First Aid for Adults, Psychological First Aid for Children, The Brain, the Body and Trauma, Coping with Difficult Workplace Situations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RCHC | Experimental | Behavioral: RCHCParticipation in the Resilience and Coping of the Healthcare Community Intervention. |
| RCHC+ | Experimental | Behavioral: RCHC+Participation in the Resilience and Coping of the Healthcare Community Intervention, support groups and one on one counseling. |
| Waitlist Control | Other | Other: Waitlist controlThis group will receive treatment as usual and will be offered services once the study is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over 18 years of age at the time of admission into the study;
- speak and read English or Spanish;
- have been identified as having experienced Hurricane Harvey or Maria or providing care to people living in areas affected by the storms;
- are employed by a participating Community Health Center or partnering agency;
- participate in AmeriCares MHPS programs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RCHCThe RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills. | Behavioural | RCHC |
| RCHC+Also: Resilience and Coping for the Healthcare Community Plus additional ServicesThe RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills. This intervention group will also receive on-going support groups and one on one counseling as needed. | Behavioural | RCHC+ |
| Waitlist controlThis group will served as the control group and will receive treatment as usual until the end of the study. At the end of the study they will have the opportunity to take part in the RCHC or RCHC+ | Other | Waitlist Control |
Primary outcome
ProQol--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
The ProQOL 5 is a 30-item scale for measuring professional quality of life among people who work in the helping professions (Stamm, 2010). The tool measures the positive aspect of compassion satisfaction (the pleasure you derive from being able to do your work well), and the negative aspect of compassion fatigue, which is composed of two parts: burnout (exhaustion, frustration and anger) and secondary trauma (work-related secondary exposure to people who have experienced traumatic events).
5 secondary outcomes
Social Provisions Scale--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Brief Resilience Scale--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Perceived Stress Scale (PSS) (10)--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Impact of Events Scale-Revised--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Brief Cope--Assessing change over time
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
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 26 Aug 2019.
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.
Tara Powell, PhD principal investigator
University of Illinois Chicago
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RCHC and RCHC+ in people with Intervention 1: Resilience and Coping for Healthcare Group and Intervention 2: Resilience and Coping for Healthcare Plus Additional Services, run by University of Illinois at Urbana-Champaign at 2 sites in 2 countries.
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 9 inclusion and 0 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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?
ProQol--Assessing change over time (time frame: Baseline, 6 weeks, 12 weeks, 18 weeks). 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 26 Aug 2019.