Psychosocial ProblemNCT07355998
Medical Improvisation Study
A study testing Group Online Improvisation Training and Standard Medical Education in people with Psychosocial Problem, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study offers improvisation training for otolaryngology residents to see if there is any impact on connection, stress, and mood. A control group of otolaryngology residents continues their standard medical education with no improvisation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Problem
- What is being tested?
- Group Online Improvisation Training and Standard Medical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 1 Jun 2026
- 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
- Otolaryngology Resident at UCSF
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Communication and Cognitive Resilience in Surgical Trainees Through Medical Improvisation
This study offers improvisation training for otolaryngology residents to see if there is any impact on connection, stress, and mood. A control group of otolaryngology residents continues their standard medical education with no improvisation.
- Conditions
- Psychosocial Problem
- Being tested
- Group Online Improvisation Training, Standard Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Online Improvisation TrainingBehavioural
3 Online Group Improvisation Training classes led by a professional is offered every other week for 1 hour to the experimental cohort.
Standard Medical EducationOther
OHNS residents continue the existing standard medical education.
| Study group | Role | What they receive |
|---|---|---|
| Improvisation Group | Experimental | Otolaryngology Residents taking Improvisation Training Receives: Behavioral: Group Online Improvisation Training |
| Control Group | Active comparator | This control group of OHNS residents continues their standard medical education. Receives: Other: Standard Medical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connection: Social Connectiveness Scale
Team dynamics and interpersonal connectedness are assessed using the Social Connectedness Scale. This is a custom survey developed specifically for this study to measure participants' sense of belonging and connection within the residency program. The scale consists of 5 items rated on a 5-point Likert scale. Total scores range from 0 to 25, with higher scores indicating a greater sense of connectedness (better outcome).
Measured: 6 weeks
Clinical Decision Making Accuracy and Response Time
Clinical decision-making under pressure is assessed using the "Intraoperative Vignettes" assessment. This is a computer-based cognitive test comprising 20 Otolaryngology-Head and Neck Surgery (OHNS) case scenarios. Participants are presented with clinical scenarios and must select the correct management decision. The outcome is reported as a composite of accuracy (total number of correct responses) and response time (time taken to select an answer). Accuracy is scored from 0 to 20, with higher scores indicating better clinical decision-making.
Measured: 6 weeks
Secondary outcomes (3)
Mood (PANAS)
Mood is assessed using the Positive and Negative Affect Schedule (PANAS). This is a validated 20-item self-report questionnaire that measures two distinct dimensions of emotion: Positive Affect (10 items) and Negative Affect (10 items). Participants rate items on a 5-point scale ranging from 1 (Very slightly or not at all) to 5 (Extremely). Scores for each subscale range from 10 to 50.
- Positive Affect: Higher scores represent higher levels of enthusiasm and energy (better outcome).
- Negative Affect: Higher scores represent higher levels of subjective distress and unpleasurable engagement (worse outcome).
Measured: 6 weeks
Anxiety and Depression (DASS-21)
Psychological distress is measured using the Depression, Anxiety, and Stress Scale-21 (DASS-21). This is a validated 21-item self-report instrument containing three subscales: Depression, Anxiety, and Stress (7 items per subscale). Participants rate how much each statement applied to them over the past week on a 4-point scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Subscale scores are calculated by summing the scores for the relevant items and multiplying by 2.
- Range: Each subscale ranges from 0 to 42.
- Interpretation: Higher scores indicate greater severity of symptoms (worse outcome).
Measured: 6 weeks
Intervention Satisfaction Score (Intervention Arm Only)
Participants in the intervention group complete an Intervention Satisfaction Survey to evaluate the curriculum and learner experience. This measure utilizes a Likert scale to assess participant feedback. Items are rated on a 5-point scale from 1 (Not true at all) to 5 (Completely true), with higher scores indicating higher satisfaction (better outcome).
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 posted21 Jan 2026
- Study start15 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial ProblemStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A control arm features OHNS residents who continue their standard medical education. The intervention group features OHNS residents who participate in group improvisation training.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Barrett, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355998
- Sponsor's protocol ID
- 25-44724
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Communication and Cognitive Resilience in Surgical Trainees Through Medical Improvisation
- ClinicalTrials.gov ID
- NCT07355998
- Acronym / sponsor ID
- 25-44724
- Conditions
- Psychosocial Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- 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.
This study offers improvisation training for otolaryngology residents to see if there is any impact on connection, stress, and mood. A control group of otolaryngology residents continues their standard medical education with no improvisation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A control arm features OHNS residents who continue their standard medical education. The intervention group features OHNS residents who participate in group improvisation training.
| Arm | Type | Receives |
|---|---|---|
| Improvisation Group | Experimental | Behavioral: Group Online Improvisation TrainingOtolaryngology Residents taking Improvisation Training |
| Control Group | Active comparator | Other: Standard Medical EducationThis control group of OHNS residents continues their standard medical education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Otolaryngology Resident at UCSF
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Group Online Improvisation Training3 Online Group Improvisation Training classes led by a professional is offered every other week for 1 hour to the experimental cohort. | Behavioural | Improvisation Group |
| Standard Medical EducationOHNS residents continue the existing standard medical education. | Other | Control Group |
Primary outcome
Connection: Social Connectiveness Scale
Time frame: 6 weeks
Team dynamics and interpersonal connectedness are assessed using the Social Connectedness Scale. This is a custom survey developed specifically for this study to measure participants' sense of belonging and connection within the residency program. The scale consists of 5 items rated on a 5-point Likert scale. Total scores range from 0 to 25, with higher scores indicating a greater sense of connectedness (better outcome).
Clinical Decision Making Accuracy and Response Time
Time frame: 6 weeks
Clinical decision-making under pressure is assessed using the "Intraoperative Vignettes" assessment. This is a computer-based cognitive test comprising 20 Otolaryngology-Head and Neck Surgery (OHNS) case scenarios. Participants are presented with clinical scenarios and must select the correct management decision. The outcome is reported as a composite of accuracy (total number of correct responses) and response time (time taken to select an answer). Accuracy is scored from 0 to 20, with higher scores indicating better clinical decision-making.
3 secondary outcomes
Mood (PANAS)
Time frame: 6 weeks
Anxiety and Depression (DASS-21)
Time frame: 6 weeks
Intervention Satisfaction Score (Intervention Arm Only)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Karen Barrett, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Online Improvisation Training and Standard Medical Education in people with Psychosocial Problem, run by University of California, San Francisco 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 21 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Connection: Social Connectiveness Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 21 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.