Behavioral SymptomsNCT01321528
Trial of Inquiry-based Stress Reduction (IBSR) Program for Health Care Professionals
An observational study of Behavioral Symptoms, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Symptoms
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Dec 2011
- Phase
- Observational
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 participants nurses in the geriatric departments in TASMC
Who may be able to join
- nurses in the geriatric departments in TASMC
- Willing to sign an informed consent
- Age 18-67
Who cannot join
- nursing assistants employees
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
yaffa lerman, MD, 972-3-6974074, yaffale@tasmc.health.gov.il
shahar Lev-ari, PhD, 972-3-6947506, shaharl@tasmc.health.gov.il
About this study
Official title: Pilot Clinical Trial of Inquiry-based Stress Reduction (IBSR) Program for Health Care Professionals
The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named "The Work", enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and can be easily implemented in daily life.
Therefore, on the basis of previous data and beneficial observations the investigators postulate that the clinical utility of IBSR mediation program may alleviate stress and rate of burnout and improve quality of life among health care professionals. Thus, we will conduct a pilot/feasibility Observational study designed to:
- Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and program satisfaction.
- investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.
Read the detailed description
Study Goals To investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.
Study methodology The proposed study is pilot/feasibility intervention study with pre and post measures. 30 participants will receive Inquiry-based stress reduction (IBSR) group intervention.
Population The pilot intervention group will consist 30 nurses at the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) who are willing to participate in this study.
Data collection procedures
- Assessments will be taken at an initial baseline orientation and at the end of the 12-week intervention.
- One week before IBSR classes will start, a baseline orientation will be held at this session, informed consent will be obtained, baseline data will be collected, and a brief overview of the IBSR program will be provided, which will highlight the 12-week class schedule.
Intervention
- Subjects will receive weekly 3.5 hour sessions conducted by two facilitators trained in IBSR and certified by BKI to conduct this intervention.
- Class size will range from 12-16 participants.
- All the sessions will be standardized and follow the training manual developed to maintain consistency in the program.
- Subjects will receive a training manual and CD's to support home practice of various forms of inquiry practices.
- The training manual will include weekly exercises, and program content related to the content identified below. In addition, the manual will include a weekly diary for recording homework practice activities.
The IBSR-BC program is a 12-week program adapted for consideration of health professionals well-being. During the process, participants will be encouraged to identify and inquire about their stressful thoughts: regarding health and illness, relationships with others, Beliefs that prevent them to promote their health, self judgments, perception of death and suffering. This intervention provides for management of specific emotional/psychological symptoms (stress, anxiety, depression) and physical symptoms, such as fatigue and sleeps disorders and enables the participants to inquire and be relieved of their stressful thoughts, and emotions caused by these thoughts. Through the use of self-inquiry practices subjects are taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self inquiry, subjects take an active role in investigating their stressful thoughts, and by this regulating their stress and managing symptoms and emotions, thus enabling them to cope better with with emotional stress and burnout.
Throughout the 12-week IBSR (HCP - health care professionals) program, all subjects will be requested to formally meditate and perform self inquiry exercises alone or with a partner for a minimum of 15 min per day.
- Conditions
- Behavioral Symptoms
- Medical subject headings
- Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBSR Intervention group | 30 nurses in the geriatric departments in TASMC |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Yaffa Lerman, MD, Principal investigator, Tel Aviv Sourasky Medical canterShahar Lev Ari, PHD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321528
- Sponsor's protocol ID
- TASMC 11 YL 0037 CTIL
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2011
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Inquiry-based Stress Reduction (IBSR) Program for Health Care Professionals
- ClinicalTrials.gov ID
- NCT01321528
- Acronym / sponsor ID
- TASMC 11 YL 0037 CTIL
- Conditions
- Behavioral Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Mar 2011 (estimated)
- 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 IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named "The Work", enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and can be easily implemented in daily life.
Therefore, on the basis of previous data and beneficial observations the investigators postulate that the clinical utility of IBSR mediation program may alleviate stress and rate of burnout and improve quality of life among health care professionals. Thus, we will conduct a pilot/feasibility Observational study designed to:
- Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and program satisfaction.
- investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.
Detailed description
Study Goals To investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.
Study methodology The proposed study is pilot/feasibility intervention study with pre and post measures. 30 participants will receive Inquiry-based stress reduction (IBSR) group intervention.
Population The pilot intervention group will consist 30 nurses at the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) who are willing to participate in this study.
Data collection procedures
- Assessments will be taken at an initial baseline orientation and at the end of the 12-week intervention.
- One week before IBSR classes will start, a baseline orientation will be held at this session, informed consent will be obtained, baseline data will be collected, and a brief overview of the IBSR program will be provided, which will highlight the 12-week class schedule.
Intervention
- Subjects will receive weekly 3.5 hour sessions conducted by two facilitators trained in IBSR and certified by BKI to conduct this intervention.
- Class size will range from 12-16 participants.
- All the sessions will be standardized and follow the training manual developed to maintain consistency in the program.
- Subjects will receive a training manual and CD's to support home practice of various forms of inquiry practices.
- The training manual will include weekly exercises, and program content related to the content identified below. In addition, the manual will include a weekly diary for recording homework practice activities.
The IBSR-BC program is a 12-week program adapted for consideration of health professionals well-being. During the process, participants will be encouraged to identify and inquire about their stressful thoughts: regarding health and illness, relationships with others, Beliefs that prevent them to promote their health, self judgments, perception of death and suffering. This intervention provides for management of specific emotional/psychological symptoms (stress, anxiety, depression) and physical symptoms, such as fatigue and sleeps disorders and enables the participants to inquire and be relieved of their stressful thoughts, and emotions caused by these thoughts. Through the use of self-inquiry practices subjects are taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self inquiry, subjects take an active role in investigating their stressful thoughts, and by this regulating their stress and managing symptoms and emotions, thus enabling them to cope better with with emotional stress and burnout.
Throughout the 12-week IBSR (HCP - health care professionals) program, all subjects will be requested to formally meditate and perform self inquiry exercises alone or with a partner for a minimum of 15 min per day.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBSR Intervention group | – | –30 nurses in the geriatric departments in TASMC |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 participants nurses in the geriatric departments in TASMC
Key inclusion criteria (3 listed)
- nurses in the geriatric departments in TASMC
- Willing to sign an informed consent
- Age 18-67
Key exclusion criteria (1 listed)
- nursing assistants employees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
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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.
Yaffa Lerman, MD principal investigator
Tel Aviv Sourasky Medical canter
Shahar Lev Ari, PHD study director
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Symptoms, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 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 28 Mar 2011. 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 Israel. 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 yaffa lerman, MD (972-3-6974074, yaffale@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.