Stress, PsychologicalNCT01412775
Psychological Group Intervention to Reduce Stress and Burnout Among Cardiac Intensive Care Nurses
A study testing short-term group intervention program in people with Stress, Psychological, run by Meir Medical Center at 1 site in Israel.
Trial summary
The study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term group intervention program on the levels of psychological stress and professional exhaustion experienced by the nursing staff in a cardiac department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- short-term group intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Jul 2012
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nurses from the cardiac intensive-care unit (CCU) of Meir Hospital, who consent to take part in the offered intervention program
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Cardiology, Meir Medical Center
Kfar Saba
Morris Mosseri, Professor, 972-9-7472587, Morris.Mosseri@clalit.org.il
Noa Vilchinsky, Ph.D, 972-3-531-8601, noav18@inter.net.il
About this study
Official title: The Contribution of a Short-term Psychological Group Intervention to Reduce Stress and Burnout Among Cardiac Intensive Care Nurses: A Pilot Study
The study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term group intervention program on the levels of psychological stress and professional exhaustion experienced by the nursing staff in a cardiac department.
Read the detailed description
Exhaustion typifies a wide variety of professions, but it is especially evident in the service and aid professions (e.g., teaching and medicine), and nurses in particular are reported to be among the most exhausted. Exhaustion is described as nursing's "professional cancer", and stress is one of the major sources leading to it.
Articles and studies referring to stress among nurses in the years 1980-1996 mapped out six sources of stress stemming from inner sources related to the employee and those stemming from hospital organization: stress that stems from work patterns and overload (such as blurring, lack of clarity, lack of control and coping with death); interpersonal relationships at work (conflicts with other employees and with the medical staff); relationships with patients and their families (insufficient preparation for coping with the emotional needs of patients and their families); work organization and management (for example, lack of staff support and staff shortages); aspects related to the nursing profession (concerns regarding the treatment and care received by the patient), as well as concerns regarding the employee's practical knowledge and skills.
Since stress can lead, among other things, to functional exhaustion and dissatisfaction at work, and since studies have shown that stress has direct and indirect effects on the quality of patient care, it is important to find ways to decrease stress and the resulting exhaustion. Such efforts will increase nurses' efficiency at work and will also improve their quality of life, not to mention that of the patients. Therefore, the current study will examine the effectiveness of a short-term group intervention program for the nursing staff of a hospital's cardiac intensive-care unit.
There are a number of ways to decrease stress which vary both in the theory behind them ( the cognitive approach, for instance, explains the source of stress as stemming from cognitive and behavioral patterns acquired during one's life whereas the dynamic approach relates to deep and unconscious layers of the mind), and in their nature (the way in which they're facilitated). Researchers who have examined the relative efficacy of the different intervention programs in decreasing stress found that cognitive therapy is the most effective approach. Cognitive-behavioral therapy (CBT) can be applied both as individual therapy and as group therapy. According to the researchers, interventions in a group setting have several advantages over individual CBT: creating open relationships between staff members, giving participants an opportunity to get to know one another, providing a platform where employees can express their feelings, developing a sincere support group which proves crucial during stressful work situations, forging a feeling of belonging, and creative solving of shared conflicts and financial issues.
The current study will examine the influence of a CBT short-term group intervention program on the levels of psychological stress and professional exhaustion experienced by the nursing staff in a cardiac department.
The goal of the study:
The current study will examine the effectiveness of a short-term group intervention program for the nursing staff of a hospital's cardiac intensive-care unit. The intervention will include three aspects:
- Psycho-educational intervention: attending a lecture about stress and exhaustion.
- Techniques for decreasing stress: experiencing relaxation techniques and guided imagery.
- A BALINT style group: analyzing actual work cases and cognitive-behavioral focusing for reframing thoughts and making them more adaptive, expressing emotions and training for more appropriate behaviors.
The study, which includes three weekly sessions, assumes that the intervention program will help to significantly decrease the participants' levels of psychological stress and professional exhaustion in comparison with their state before participation in the program, and also in comparison with those who didn't take part in the program (i.e., the control group).
The hypotheses of the study:
- Participation in the intervention program will be related to decreased levels of psychological stress. The nursing staff in the program will demonstrate a lower level of negative psychological affect after participation. The level of stress will decrease significantly in comparison with the participants' state in the beginning of the program, and in comparison with professionals who didn't participate in the program (the control group).
- Participation in the program will be related to reduced exhaustion levels: the nursing staff members who participate in the program will report lower exhaustion levels than they reported before the program, and in comparison with the control group (members of the nursing staff who didn't participate in the intervention program).
- Conditions
- Stress, Psychological
- Being tested
- short-term group intervention program
- Keywords
- stress, burnout, exhaustion
- Medical subject headings
- Stress, Psychological, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-term group intervention programBehavioural
Also called intervention program, short-term group intervention
The intervention will include three aspects: Psycho-educational intervention: attending a lecture about stress and exhaustion; Techniques for decreasing stress: experiencing relaxation techniques and guided imagery and a BALINT style group:analyzing actual work cases and cognitive-behavioral focusing for reframing thoughts and making them more adaptive, expressing emotions and training for more appropriate behaviors.
The study includes three weekly sessions, Each session will be 90 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Psychological stress and exhaustion | Experimental | Twenty four male and female nurses from the cardiac intensive-care unit (CCU) of Meir Hospital, who consent to take part in the offered intervention program, will participate in the study. The participants will be randomly assigned to an experiment group of 12 participants and a control group of 12 participants. Receives: Behavioral: short-term group intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of psychological stress
The Nursing Stress Scale (NSS) has been shown to be a valid and reliable instrument to assess occupational stressors among nurses.
Measured: 6 weeks
Secondary outcomes (1)
Exhaustion levels
Nurse's burnout symptoms: The SMBS questionnaire (Shirom-Melamed Burnout), will be used.This questionnaire reflects the participant's exhaustion in their workplace.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Mosseri, Professor, Principal investigator, Department of Cardiology, Meir Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412775
- Sponsor's protocol ID
- MMC11XXX-XXCTIL
- Status last verified
- Aug 2011
- First submitted
- 2 May 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of a Short-term Psychological Group Intervention to Reduce Stress and Burnout Among Cardiac Intensive Care Nurses: A Pilot Study
- ClinicalTrials.gov ID
- NCT01412775
- Acronym / sponsor ID
- MMC11XXX-XXCTIL
- Conditions
- Stress, Psychological
- Keywords
- stress, burnout, exhaustion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Aug 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 study will examine the influence of a Cognitive Behavioral Therapy (CBT) short-term group intervention program on the levels of psychological stress and professional exhaustion experienced by the nursing staff in a cardiac department.
Detailed description
Exhaustion typifies a wide variety of professions, but it is especially evident in the service and aid professions (e.g., teaching and medicine), and nurses in particular are reported to be among the most exhausted. Exhaustion is described as nursing's "professional cancer", and stress is one of the major sources leading to it.
Articles and studies referring to stress among nurses in the years 1980-1996 mapped out six sources of stress stemming from inner sources related to the employee and those stemming from hospital organization: stress that stems from work patterns and overload (such as blurring, lack of clarity, lack of control and coping with death); interpersonal relationships at work (conflicts with other employees and with the medical staff); relationships with patients and their families (insufficient preparation for coping with the emotional needs of patients and their families); work organization and management (for example, lack of staff support and staff shortages); aspects related to the nursing profession (concerns regarding the treatment and care received by the patient), as well as concerns regarding the employee's practical knowledge and skills.
Since stress can lead, among other things, to functional exhaustion and dissatisfaction at work, and since studies have shown that stress has direct and indirect effects on the quality of patient care, it is important to find ways to decrease stress and the resulting exhaustion. Such efforts will increase nurses' efficiency at work and will also improve their quality of life, not to mention that of the patients. Therefore, the current study will examine the effectiveness of a short-term group intervention program for the nursing staff of a hospital's cardiac intensive-care unit.
There are a number of ways to decrease stress which vary both in the theory behind them ( the cognitive approach, for instance, explains the source of stress as stemming from cognitive and behavioral patterns acquired during one's life whereas the dynamic approach relates to deep and unconscious layers of the mind), and in their nature (the way in which they're facilitated). Researchers who have examined the relative efficacy of the different intervention programs in decreasing stress found that cognitive therapy is the most effective approach. Cognitive-behavioral therapy (CBT) can be applied both as individual therapy and as group therapy. According to the researchers, interventions in a group setting have several advantages over individual CBT: creating open relationships between staff members, giving participants an opportunity to get to know one another, providing a platform where employees can express their feelings, developing a sincere support group which proves crucial during stressful work situations, forging a feeling of belonging, and creative solving of shared conflicts and financial issues.
The current study will examine the influence of a CBT short-term group intervention program on the levels of psychological stress and professional exhaustion experienced by the nursing staff in a cardiac department.
The goal of the study:
The current study will examine the effectiveness of a short-term group intervention program for the nursing staff of a hospital's cardiac intensive-care unit. The intervention will include three aspects:
- Psycho-educational intervention: attending a lecture about stress and exhaustion.
- Techniques for decreasing stress: experiencing relaxation techniques and guided imagery.
- A BALINT style group: analyzing actual work cases and cognitive-behavioral focusing for reframing thoughts and making them more adaptive, expressing emotions and training for more appropriate behaviors.
The study, which includes three weekly sessions, assumes that the intervention program will help to significantly decrease the participants' levels of psychological stress and professional exhaustion in comparison with their state before participation in the program, and also in comparison with those who didn't take part in the program (i.e., the control group).
The hypotheses of the study:
- Participation in the intervention program will be related to decreased levels of psychological stress. The nursing staff in the program will demonstrate a lower level of negative psychological affect after participation. The level of stress will decrease significantly in comparison with the participants' state in the beginning of the program, and in comparison with professionals who didn't participate in the program (the control group).
- Participation in the program will be related to reduced exhaustion levels: the nursing staff members who participate in the program will report lower exhaustion levels than they reported before the program, and in comparison with the control group (members of the nursing staff who didn't participate in the intervention program).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological stress and exhaustion | Experimental | Behavioral: short-term group intervention programTwenty four male and female nurses from the cardiac intensive-care unit (CCU) of Meir Hospital, who consent to take part in the offered intervention program, will participate in the study. The participants will be randomly assigned to an experiment group of 12 participants and a control group of 12 participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses from the cardiac intensive-care unit (CCU) of Meir Hospital, who consent to take part in the offered intervention program
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| short-term group intervention programAlso: intervention program, short-term group interventionThe intervention will include three aspects: Psycho-educational intervention: attending a lecture about stress and exhaustion; Techniques for decreasing stress: experiencing relaxation techniques and guided imagery and a BALINT style group:analyzing actual work cases and cognitive-behavioral focusing for reframing thoughts and making them more adaptive, expressing emotions and training for more appropriate behaviors. The study includes three weekly sessions, Each session will be 90 minutes in duration. | Behavioural | Psychological stress and exhaustion |
Primary outcome
Symptoms of psychological stress
Time frame: 6 weeks
The Nursing Stress Scale (NSS) has been shown to be a valid and reliable instrument to assess occupational stressors among nurses.
1 secondary outcome
Exhaustion levels
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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.
Morris Mosseri, Professor principal investigator
Department of Cardiology, Meir Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short-term group intervention program in people with Stress, Psychological, run by Meir 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 1 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 30 Aug 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 Morris Mosseri, Professor (972-9-7472587, Morris.Mosseri@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of psychological stress (time frame: 6 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 30 Aug 2011.