Psychological StressNCT01593683
Waitlist-controlled Trial of a Psychological Education Program for Nurses
A study testing Psychological education program for nurses in people with Psychological Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Psychological education program for nurses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2013
- 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
- Must have RN degree
- Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit
Who cannot join
- Participation in earlier pilot trial of the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.
- Conditions
- Psychological Stress
- Being tested
- Psychological education program for nurses
- Keywords
- Oncology service, Nursing staff, Psychosocial intervention, Coping skills
- Medical subject headings
- Stress, Psychological, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological education program for nursesBehavioural
Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.
| Study group | Role | What they receive |
|---|---|---|
| Psychological education program | Experimental | Patients receive the psychological education program upon study enrollment. Receives: Behavioral: Psychological education program for nurses |
| Waitlist | No intervention | Participants are assigned to a 16-week wait-list period upon enrollment. Participants are invited to receive the psychological education program following the waitlist period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory
Measured: At approximately 16 and 32 weeks post-baseline
Secondary outcomes (1)
Change in from baseline in medical errors as measured by the Medical Errors Questionnaire
Measured: At approximately 16 and 32 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Pirl, Massachusetts General Hospital
- Investigators
- William F Pirl, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593683
- Sponsor's protocol ID
- MGH 2011-P-002799
- Status last verified
- Jul 2013
- First submitted
- 4 May 2012
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waitlist-controlled Trial of a Psychological Education Program for Nurses
- ClinicalTrials.gov ID
- NCT01593683
- Acronym / sponsor ID
- MGH 2011-P-002799
- Conditions
- Psychological Stress
- Keywords
- Oncology service, Nursing staff, Psychosocial intervention, Coping skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 May 2012 (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 purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological education program | Experimental | Behavioral: Psychological education program for nursesPatients receive the psychological education program upon study enrollment. |
| Waitlist | No intervention | –Participants are assigned to a 16-week wait-list period upon enrollment. Participants are invited to receive the psychological education program following the waitlist period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have RN degree
- Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit
Key exclusion criteria (1 listed)
- Participation in earlier pilot trial of the intervention
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 |
|---|---|---|
| Psychological education program for nursesApproximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician. | Behavioural | Psychological education program |
Primary outcome
Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory
Time frame: At approximately 16 and 32 weeks post-baseline
1 secondary outcome
Change in from baseline in medical errors as measured by the Medical Errors Questionnaire
Time frame: At approximately 16 and 32 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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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.
William F Pirl, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological education program for nurses in people with Psychological Stress, run by Massachusetts General Hospital at 1 site in United States.
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 2 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 10 Jul 2013. 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?
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?
Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory (time frame: At approximately 16 and 32 weeks post-baseline). 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 10 Jul 2013.