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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in Israel

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

  1. Assessments will be taken at an initial baseline orientation and at the end of the 12-week intervention.
  2. 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

  1. Subjects will receive weekly 3.5 hour sessions conducted by two facilitators trained in IBSR and certified by BKI to conduct this intervention.
  2. Class size will range from 12-16 participants.
  3. All the sessions will be standardized and follow the training manual developed to maintain consistency in the program.
  4. Subjects will receive a training manual and CD's to support home practice of various forms of inquiry practices.
  5. 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.

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 groups in NCT01321528
Study groupRoleWhat they receive
IBSR Intervention group30 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.

  1. First posted23 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

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)
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

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.

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