Cognitive ChangeNCT06511102
Impact of GPT Use on Essay Writing Performance and Cognitive Abilities
A study testing GPT Support in people with Cognitive Change and Well-Being, Psychological, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The goal of this randomized controlled lab experiment is to examine if using generated artificial intelligence (AI) technology will affect people's academic performance and cognitive abilities in the context of analytical writing among college students. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Well-Being, Psychological
- What is being tested?
- GPT Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2024to 20 Feb 2025
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time university student.
- Able to read and write in English.
- Use the computer most days of the week.
- Have not taken, nor currently preparing for, the Graduate Record Examinations (GRE).
- Do not wear glasses (contact lenses are allowed).
- Have no eye impairment.
- Not currently taking any opioids, epinephrine, or anti-hypertensive drugs.
- During the experiment, not wearing any makeup around the eyes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Core Facility for Neuroscience of Self-Regulation, Heidelberg University
Heidelberg
About this study
Official title: A Randomized Controlled Trial on the Impact of Using Generative Artificial Intelligence on Analytical Writing Performance and Cognitive Abilities
The goal of this randomized controlled lab experiment is to examine if using generated artificial intelligence (AI) technology will affect people's academic performance and cognitive abilities in the context of analytical writing among college students. The main questions it aims to answer are:
- Does using the technology affect students' writing performance?
- Does using the technology affect students' cognitive effort during the writing process?
Read more
Participants will be randomly assigned to either a control group, which is writing without AI assistance, or an experimental group, which is writing with the assistance of ChatGPT. Researchers will compare the two groups to see if ChatGPT affects students' writing performance and cognitive effort.
For each participant, the lab experiment will last for no more than 1.5 hours. An eye-tracker will monitor the participant's gaze activities and pupil size. A functional near-infrared spectroscopy (fNIRS) will monitor the participant's brain activities in the frontal lobe. During the experiment, participants will be asked to:
- Read learning materials on analytical writing techniques.
- Based on the previously provided materials, complete an analytical writing assignment that will take approximately 30 minutes either with or without the aid of ChatGPT.
- Answer survey questions about their experience with the writing assignment, attitudes on using ChatGPT, and demographic backgrounds.
- Conditions
- Cognitive Change, Well-Being, Psychological
- Being tested
- GPT Support
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPT SupportBehavioural
The computer interface used for the essay writing task follows a split-screen design. The writing instructions and text input field are administered on a survey platform, placed on the left half of the screen. ChatGPT is placed on the right half of the screen for technology assistance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | In the intervention arm, participants are instructed to use ChatGPT for assistance to complete an analytical writing task. Receives: Behavioral: GPT Support |
| Control arm | No intervention | In the control arm, participants are instructed to complete an analytical writing task independently without access to any technology assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Writing Performance
The essay writing task is derived from the Analytical Writing section in the Graduate Record Examinations (GRE), which is a worldwide and standardized computer-based exam developed by the Educational Testing Service (ETS). The participants' essays will be scored on a scale from 0 to 6 by an automatic and validated third-party scoring tool that is also developed by ETS.
Measured: 1.5 hours
Cognitive Effort Measured by Pupil Size
Cognitive effort is quantified by monitoring changes in pupil size. To achieve this, pupil diameters are recorded throughout the writing task using a near-infrared eye tracker, specifically the Tobii Pro Fusion model. At the start of the experiment, individual baseline pupil diameters are measured during a 30-second relaxation task.
Measured: 1.5 hours
Secondary outcomes (8)
Self-Perception of Writing Performance
This is a one-item scale:
Using the same grading rubric from before, what score do you think your essay should get (0 being the lowest and 6 being the highest)?
The score ranges from 0 to 6. A higher score indicates higher self-perceived writing performance. The variable is treated as a continuous variable.
Measured: 1.5 hours
Self-Perception of Cognitive Effort
This is a one-item Likert scale adapted from the National Aeronautics and Space Administration-task load index (NASA-TLX; Hart, 2006; Hart \& Staveland, 1988):
On a scale of 1 to 7, rate how hard you have to work to accomplish your level of performance.
The Likert score ranges from 1 to 7 (1 being "very low" and 7 being "very high"). A higher score indicates higher self-perceived cognitive effort. The variable is treated as a continuous variable.
References:
- Hart, S. G. (2006). Nasa-Task Load Index (NASA-TLX); 20 Years Later. Proceedings of the Human Factors and Ergonomics Society Annual Meeting. https://doi.org/10.1177/154193120605000909
- Hart, S. G., \& Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. In Advances in Psychology (Vol. 52, pp. 139-183). North-Holland.
Measured: 1.5 hours
Cognitive Effort Measured by Cortical Hemodynamic Activity in the Frontal Lobe
Cognitive Effort is quantified by monitoring changes in the cortical hemodynamic activity in the frontal lobe. To achieve this, the brain activity is recorded throughout the writing task using a functional near-infrared spectroscopy (fNIRS), specifically the NIRSport2 model.
Measured: 1.5 hours
Self-Perception of Stress
This is a one-item Likert sub-scale adapted from the Primary Appraisal Secondary Appraisal scale (PASA; Gaab, 2009; Pollak et al., 2020):
On a scale of 1 to 7, how much would you agree or disagree with the following statement on perceived stress: The analytical writing assignment was stressful to me.
The Likert score ranges from 1 to 7 (1 being "strongly disagree" and 7 being "strongly agree"). A higher score indicates higher self-perceived stress. The variable is treated as a continuous variable.
References:
- Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal. A questionnaire for the assessment of cognitive appraisals of situations. Verhaltenstherapie, 19(2), 114-115.
- Pollak, A., Paliga, M., Pulopulos, M. M., Kozusznik, B., \& Kozusznik, M. W. (2020). Stress in manual and autonomous modes of collaboration with a cobot. Computers in Human Behavior, 112, 106469. https://doi.org/10.1016/j.chb.2020.106469
Measured: 1.5 hours
Self-Perception of Challenge
This is a one-item Likert sub-scale adapted from the Primary Appraisal Secondary Appraisal scale (PASA; Gaab, 2009; Pollak et al., 2020):
On a scale of 1 to 7, how much would you agree or disagree with the following statement on perceived challenge: I find the analytical writing assignment a challenge.
The Likert score ranges from 1 to 7 (1 being "strongly disagree" and 7 being "strongly agree"). A higher score indicates higher self-perceived challenge. The variable is treated as a continuous variable.
References:
- Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal. A questionnaire for the assessment of cognitive appraisals of situations. Verhaltenstherapie, 19(2), 114-115.
- Pollak, A., Paliga, M., Pulopulos, M. M., Kozusznik, B., \& Kozusznik, M. W. (2020). Stress in manual and autonomous modes of collaboration with a cobot. Computers in Human Behavior, 112, 106469. https://doi.org/10.1016/j.chb.2020.106469
Measured: 1.5 hours
Self-Efficacy in Writing
This is a sixteen-item Likert scale that measures three dimensions of writing self-efficacy: ideation, convention and self-regulation (Bruning et al., 2013). The Likert score ranges from 1 to 7 (1 being "strongly disagree" and 7 being "strongly agree"). A higher score indicates higher self-efficacy. The three dimensions will be treated separately, each as a continuous variable.
Reference:
- Bruning, R., Dempsey, M., Kauffman, D. F., McKim, C., \& Zumbrunn, S. (2013). Examining dimensions of self-efficacy for writing. Journal of educational psychology, 105(1), 25.
Measured: 1.5 hours
Situational Interest in Analytical Writing
This is a four-item Likert scale adapted from the situational interest scale (Hulleman et al., 2010). This scale measures participants' situational interest in analytical writing:
On a scale of 1 to 7, how much would you agree or disagree with the following statements on your interest in the analytical writing assignment that you just completed?
- The analytical writing assignment was interesting.
- Working on the essay was fun.
- I enjoyed writing the essay.
- The analytical writing assignment was enjoyable.
The Likert score ranges from 1 to 7 (1 being "strongly disagree" and 7 being "strongly agree"). A higher score indicates higher situational interest. The variable is treated as a continuous variable.
Reference:
- Hulleman, C. S., Godes, O., Hendricks, B. L., \& Harackiewicz, J. M. (2010). Enhancing interest and performance with a utility value intervention. Journal of Educational Psychology, 102(4), 880.
Measured: 1.5 hours
Behavioral Intention in Using ChatGPT
This is a two-item Likert scale that measures participants' behavioral intention in using ChatGPT in the future for essay writing tasks (Albayati, 2024):
On a scale of 1 to 7, how much would you agree or disagree with the following statements on using ChatGPT in essay writing assignments?
- If I have access to ChatGPT, I would use it for essay writing tasks.
- I plan to use ChatGPT in the future if I have an essay writing task.
The Likert score ranges from 1 to 7 (1 being "strongly disagree" and 7 being "strongly agree"). A higher score indicates higher behavioral intention in using ChatGPT. The variable is treated as a continuous variable.
Reference:
- Albayati, H. (2024). Investigating undergraduate students' perceptions and awareness of using ChatGPT as a regular assistance tool: A user acceptance perspective study. Computers and Education: Artificial Intelligence, 6, 100203. https://doi.org/10.1016/j.caeai.2024.100203
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start18 Jul 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simiao Chen, University Hospital Heidelberg
- Investigators
- Till Bärnighausen, Principal investigator, Heidelberg Institute of Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511102
- Sponsor's protocol ID
- S-117/2024
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Wang Y, Wustenberg T, Kizilcec RF, Fan Y, Li Y, Lu B, Yuan M, Zhang J, Zhang Z, Geldsetzer P, Chen S, Barnighausen T. Effects of generative artificial intelligence on cognitive effort and task performance: study protocol for a randomized controlled experiment among college students. Trials. 2025 Jul 11;26(1):244. doi: 10.1186/s13063-025-08950-3.
PubMed 40646586
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Impact of Using Generative Artificial Intelligence on Analytical Writing Performance and Cognitive Abilities
- ClinicalTrials.gov ID
- NCT06511102
- Acronym / sponsor ID
- S-117/2024
- Conditions
- Cognitive Change, Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 19 Jul 2024 (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.
The goal of this randomized controlled lab experiment is to examine if using generated artificial intelligence (AI) technology will affect people's academic performance and cognitive abilities in the context of analytical writing among college students. The main questions it aims to answer are:
- Does using the technology affect students' writing performance?
- Does using the technology affect students' cognitive effort during the writing process?
Participants will be randomly assigned to either a control group, which is writing without AI assistance, or an experimental group, which is writing with the assistance of ChatGPT. Researchers will compare the two groups to see if ChatGPT affects students' writing performance and cognitive effort.
For each participant, the lab experiment will last for no more than 1.5 hours. An eye-tracker will monitor the participant's gaze activities and pupil size. A functional near-infrared spectroscopy (fNIRS) will monitor the participant's brain activities in the frontal lobe. During the experiment, participants will be asked to:
- Read learning materials on analytical writing techniques.
- Based on the previously provided materials, complete an analytical writing assignment that will take approximately 30 minutes either with or without the aid of ChatGPT.
- Answer survey questions about their experience with the writing assignment, attitudes on using ChatGPT, and demographic backgrounds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: GPT SupportIn the intervention arm, participants are instructed to use ChatGPT for assistance to complete an analytical writing task. |
| Control arm | No intervention | –In the control arm, participants are instructed to complete an analytical writing task independently without access to any technology assistance. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Full-time university student.
- Able to read and write in English.
- Use the computer most days of the week.
- Have not taken, nor currently preparing for, the Graduate Record Examinations (GRE).
- Do not wear glasses (contact lenses are allowed).
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 |
|---|---|---|
| GPT SupportThe computer interface used for the essay writing task follows a split-screen design. The writing instructions and text input field are administered on a survey platform, placed on the left half of the screen. ChatGPT is placed on the right half of the screen for technology assistance. | Behavioural | Intervention arm |
Primary outcome
Writing Performance
Time frame: 1.5 hours
The essay writing task is derived from the Analytical Writing section in the Graduate Record Examinations (GRE), which is a worldwide and standardized computer-based exam developed by the Educational Testing Service (ETS). The participants' essays will be scored on a scale from 0 to 6 by an automatic and validated third-party scoring tool that is also developed by ETS.
Cognitive Effort Measured by Pupil Size
Time frame: 1.5 hours
Cognitive effort is quantified by monitoring changes in pupil size. To achieve this, pupil diameters are recorded throughout the writing task using a near-infrared eye tracker, specifically the Tobii Pro Fusion model. At the start of the experiment, individual baseline pupil diameters are measured during a 30-second relaxation task.
8 secondary outcomes
Self-Perception of Writing Performance
Time frame: 1.5 hours
Self-Perception of Cognitive Effort
Time frame: 1.5 hours
Cognitive Effort Measured by Cortical Hemodynamic Activity in the Frontal Lobe
Time frame: 1.5 hours
Self-Perception of Stress
Time frame: 1.5 hours
Self-Perception of Challenge
Time frame: 1.5 hours
Self-Efficacy in Writing
Time frame: 1.5 hours
Situational Interest in Analytical Writing
Time frame: 1.5 hours
Behavioral Intention in Using ChatGPT
Time frame: 1.5 hours
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 9 Jul 2025.
- Derived from this study: PubMed 40646586Chen Y, Wang Y, Wustenberg T, Kizilcec RF, Fan Y, Li Y, Lu B, Yuan M, Zhang J, Zhang Z, Geldsetzer P, Chen S, Barnighausen T. Effects of generative artificial intelligence on cognitive effort and task performance: study protocol for a randomized controlled experiment among college students. Trials. 2025 Jul 11;26(1):244. doi: 10.1186/s13063-025-08950-3.
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
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.
Till Bärnighausen principal investigator
Heidelberg Institute of Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPT Support in people with Cognitive Change and Well-Being, Psychological, run by University Hospital Heidelberg at 1 site in Germany.
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 8 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 9 Jul 2025. 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 Germany. 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?
Writing Performance (time frame: 1.5 hours). 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?
On the ClinicalTrials.gov record for NCT06511102, which also lists 1 linked publication.
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 9 Jul 2025.