- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06806150
The INSPIRE Study: INvestigation of Swiss Physicians Inner-life, Resilience, and Emotions (INSPIRE)
The goal of this clinical trial, nested within an observational cohort study, is to evaluate whether two positive psychology web-based interventions can reduce emotional exhaustion and improve overall well-being in practicing physicians in Switzerland. The main questions it aims to answer are:
Does participation in positive psychology interventions reduce emotional exhaustion at three months post-intervention? How do these interventions impact physician wellness, job satisfaction, comfort with end-of-life communication and other aspects of physicians' emotional well-being?
Researchers will compare the effects of two intervention arms (general reflection vs. work-specific reflection) to a control group to determine whether focusing on work-specific aspects leads to greater improvements in emotional exhaustion and job-related outcomes.
Participants will:
- Complete an 8-day intervention consisting of positive psychology activities delivered online.
- Complete baseline and follow-up assessments over the study period
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Burnout, emotional exhaustion, and moral distress are widespread among physicians, negatively impacting patient care, job satisfaction, and physician retention in the workforce. While interventions targeting burnout exist, many require significant time commitments or institutional support, limiting accessibility.
Positive psychology interventions, which emphasize strengths-based approaches such as self-reflection, gratitude, and self-compassion, have shown promise in enhancing resilience and well-being.
The INSPIRE study is a randomized controlled trial (RCT) nested within an observational cohort using a Trial within Cohort (TwiC) design. It evaluates two web-based positive psychology interventions aimed at reducing emotional exhaustion and improving physician well-being.
A subset of cohort participants is randomized into one of three arms: a control group, a general life reflection intervention, or a work-focused reflection intervention. The interventions consist of an 8-day structured self-reflection program delivered online.
The study employs automated randomization, triple masking (participants, investigators, and outcome assessors), and longitudinal assessments over one year. Findings will inform the scalability of low-burden interventions for physician burnout prevention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sofia C Zambrano, PhD
- Phone Number: +41 31 684 57 76
- Email: sofia.zambrano@unibe.ch
Study Contact Backup
- Name: Robert Staeck, MSc
- Email: robert.staeck@unibe.ch
Study Locations
-
-
-
Bern, Switzerland, 3012
- University of Bern
-
Contact:
- Robert Staeck, MSc
- Email: robert.staeck@unibe.ch
-
Contact:
- Sofia C Zambrano, PhD
- Email: sofia.zambrano@unibe.ch
-
Principal Investigator:
- Sofia C Zambrano, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be a practicing physician in Switzerland
- Working at least 40% in a clinical capacity
- Be willing and able to provide informed consent
- Expecting to be professionally active until 2028
Exclusion Criteria:
- Retired physician or physician seeking retirement within 3 years from first participation in the study
- Physician unable to participate in one of the study languages: English, German, or French
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention 1 - General Positive Psychology Reflection
Participants engage in an 8-day web-based intervention involving positive psychology exercises focused on general life situations.
|
An 8-day web-based positive psychology intervention encouraging participants to reflect on positive aspects of their daily lives.
Activities include gratitude exercises, self-compassion writing, and recognizing meaningful moments.
|
|
Experimental: Intervention 2 - Work-Specific Positive Psychology Reflection
Participants engage in the same 8-day web-based intervention, but the focus is specifically on positive reflections related to work and patient interactions.
|
An 8-day web-based positive psychology intervention encouraging participants to reflect on positive aspects of their work experiences.
Activities include gratitude exercises, self-compassion writing, and recognizing meaningful professional interactions.
|
|
No Intervention: Control group
Participants complete assessments but do not receive the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Emotional Exhaustion
Time Frame: 3 months post-intervention
|
Emotional Exhaustion subscale of the MBI-HSS
|
3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Emotional Exhaustion
Time Frame: Baseline to 2 weeks, 1 month, 6 months, 1 year
|
Emotional Exhaustion subscale of the MBI-HSS
|
Baseline to 2 weeks, 1 month, 6 months, 1 year
|
|
Change in Depersonalization
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Depersonalization subscale of the MBI-HSS
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Personal Accomplishment
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Personal accomplishment subscale of the MBI-HSS
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Physician wellbeing
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Physician Wellness Inventory (PWI)
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Job Satisfaction
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Physician Job Satisfaction Scale
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in comfort with End-of-Life Communication
Time Frame: Baseline to 1 month, 3 months, 6 months, 1 year
|
Communication about End of Life Survey
|
Baseline to 1 month, 3 months, 6 months, 1 year
|
|
Change in Mindfulness
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Mindful Attention Awareness Scale (MAAS-Trait)
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Compassionate Care
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Santa Clara Brief Compassion Scale
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Emotion Regulation
Time Frame: Baseline to 1 month, 3 months, 6 months, 1 year
|
Emotion Regulation Questionnaire (ERQ)
|
Baseline to 1 month, 3 months, 6 months, 1 year
|
|
Change in Positive and Negative Affect
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Positive and Negative Affect Schedule (PANAS)
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
|
Change in Authenticity
Time Frame: Baseline to 3 months, 6 months, 1 year
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Inauthenticity Scale
|
Baseline to 3 months, 6 months, 1 year
|
|
Resilience
Time Frame: Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
2-item Connor-Davidson resilience scale
|
Baseline to 2 weeks, 1 month, 3 months, 6 months, 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived impact of the INSPIRE Interventions
Time Frame: Within 6 months post-intervention
|
Qualitative interviews with a subset of trial participants to understand perceived impact of the INSPIRE interventions.
|
Within 6 months post-intervention
|
|
Acceptability of the INSPIRE Interventions
Time Frame: Within 6 months post-intervention
|
Qualitative interviews with a subset of trial participants to understand acceptability of the INSPIRE interventions.
|
Within 6 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sofia C Zambrano, PhD, University of Bern
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-00963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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