Burnout SyndromeNCT03535493
The Effect of ACT and Float REST on Burnout Syndrome.
A study testing Acceptance and Commitment Therapy (ACT), Float REST and ACT + Float REST in people with Burnout Syndrome, run by Amrinder Babbra at 1 site in United States.
Trial summary
In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy (ACT), a unique empirically based psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Float REST and ACT + Float REST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 27 Aug 2018
- 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Trial locations and contacts
1 site in 1 country.
United States1 site
International Behavioral Research Institute
Saint Charles, Illinois, 60174
About this study
Official title: The Effect of Acceptance and Commitment Therapy (ACT) and Float REST (Restricted Environmental Stimulation Therapy) on Burnout Syndrome.
In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy (ACT), a unique empirically based psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility. In 1954, John Lilly, a cognitive neuroscientist, developed the sensory deprivation tank (known today as Floatation Restricted Environmental Stimulation Therapy - Float REST), to access a wide range of healing, higher brain functions, and meditation through an unparalleled deep relaxation state. In this study, the investigators aim to examine whether participants in the ACT + Float REST condition will have larger decreases of the burnout phenomenon than those who receive either only ACT or Float REST.
- Conditions
- Burnout Syndrome
- Being tested
- Acceptance and Commitment Therapy (ACT), Float REST, ACT + Float REST
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress.
Float RESTBehavioural
Also called Float Therapy, Isolation Tank, Sensory Deprivation Tank
A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.
ACT + Float RESTBehavioural
The combined intervention will combine ACT and Float REST. An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress. A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Active comparator | Not described Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Float REST | Active comparator | Not described Receives: Behavioral: Float REST |
| ACT + Float REST | Experimental | Not described Receives: Behavioral: ACT + Float REST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Change in Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
A 22 item scale that measures depersonalization, emotional exhaustion, and personal accomplishment. It is designed for professionals in human services in an array of occupations including nurses, physicians, health aides, social workers, health counselors, therapists, police, correctional officers, clergy, and other fields focused on helping people live better lives by offering guidance, preventing harm, and ameliorating cognitive, emotional, or physical problems.
Measured: Metric will be used as screening prior to study intervention; continuous measurement at week 2, week 4, week 6, week 8 and at one month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jun 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Why it stopped: Ethics Committee concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amrinder Babbra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amrinder Babbra, International Behavioral Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535493
- Sponsor's protocol ID
- IBRI
- Status last verified
- Aug 2018
- First submitted
- 13 May 2018
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy (ACT) and Float REST (Restricted Environmental Stimulation Therapy) on Burnout Syndrome.
- ClinicalTrials.gov ID
- NCT03535493
- Acronym / sponsor ID
- IBRI
- Conditions
- Burnout Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ethics Committee concerns.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Amrinder BabbraUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 24 May 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.
In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy (ACT), a unique empirically based psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility. In 1954, John Lilly, a cognitive neuroscientist, developed the sensory deprivation tank (known today as Floatation Restricted Environmental Stimulation Therapy - Float REST), to access a wide range of healing, higher brain functions, and meditation through an unparalleled deep relaxation state. In this study, the investigators aim to examine whether participants in the ACT + Float REST condition will have larger decreases of the burnout phenomenon than those who receive either only ACT or Float REST.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Active comparator | Behavioral: Acceptance and Commitment Therapy (ACT) |
| Float REST | Active comparator | Behavioral: Float REST |
| ACT + Float REST | Experimental | Behavioral: ACT + Float REST |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Float RESTAlso: Float Therapy, Isolation Tank, Sensory Deprivation TankA float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes. | Behavioural | Float REST |
| ACT + Float RESTThe combined intervention will combine ACT and Float REST. An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress. A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes. | Behavioural | ACT + Float REST |
Primary outcome
Assessing Change in Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
Time frame: Metric will be used as screening prior to study intervention; continuous measurement at week 2, week 4, week 6, week 8 and at one month follow-up.
A 22 item scale that measures depersonalization, emotional exhaustion, and personal accomplishment. It is designed for professionals in human services in an array of occupations including nurses, physicians, health aides, social workers, health counselors, therapists, police, correctional officers, clergy, and other fields focused on helping people live better lives by offering guidance, preventing harm, and ameliorating cognitive, emotional, or physical problems.
Results and safety
The study was stopped early (reason given: Ethics Committee concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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.
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 Acceptance and Commitment Therapy (ACT), Float REST and ACT + Float REST in people with Burnout Syndrome, run by Amrinder Babbra at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. 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 was stopped early (reason given: Ethics Committee concerns.). Results are not available in the source record.
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?
Assessing Change in Maslach Burnout Inventory - Human Services Survey (MBI-HSS) (time frame: Metric will be used as screening prior to study intervention; continuous measurement at week 2, week 4, week 6, week 8 and at one month follow-up.). 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 29 Aug 2018.