- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06813066
Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence
Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence: A Proof-of-Concept Study of In Silico Psychotherapy Research
Study Overview
Status
Conditions
Detailed Description
Health research has evolved significantly, increasingly incorporating computational models that improve our understanding and effectiveness of medical interventions. This shift from traditional to computational methods represents a major advancement in medical research, offering a more sustainable and innovative approach for conceptual advances and therapeutic discovery. In silico models, based on scientific simulation, use computational algorithms to mimic real-world systems or processes. This virtual environment allows researchers to explore phenomena impractical, unethical, dangerous, expensive, or impossible to study otherwise.
Psychotherapy is widely acknowledged as a primary treatment for a variety of mental health conditions, from depression and anxiety to personality disorders, offering significant pathways to recovery and improved quality of life. Yet current methods have shown limited effectiveness, prompting a need for innovative research approaches. In silico psychotherapy research leverages computational simulations, large language models (LLMs), and generative artificial intelligence to explore and refine psychotherapeutic interventions. By simulating human-like conversations, this approach provides insights into therapy dynamics and holds promise for revolutionizing therapist training and expanding treatment techniques.
This study aims to establish a proof-of-concept for simulating psychotherapeutic sessions using LLMs, focusing specifically on motivational interviewing. It involves the simulation of 512 psychotherapy sessions using LLMs as well as 8 real-world psychotherapy transcripts. By modeling human interactions, the study seeks to enhance healthcare delivery, therapist training, and personalized psychotherapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Simulation of psychotherapy sessions of conversations between an adult person presenting with a mental or behavioral health problem and a psychotherapist using large language models and 8 real-world transcripts
Exclusion Criteria:
- Simulation protocols with severe simulation errors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Levels of Common Therapeutic Factors
In this group, the patient-large language model (LLM) interacted with a therapist-LLM prompted to exhibit high levels of positive common factors.
|
The therapist large language model (LLM) is designed to show high levels of empathy, warmth, and genuineness.
This setup aims to create a supportive and trusting therapeutic environment to improve patient engagement.
High levels of these positive factors are linked to better psychotherapy outcomes and a stronger therapist-patient relationship.
|
|
Experimental: Low Levels of Common Therapeutic Factors
In this group, the patient-large language model (LLM) interacted with a therapist-LLM prompted to exhibit low levels of positive common factors.
|
The therapist LLM for this group is designed to show low levels of empathy, warmth, and genuineness.
This setup aims to examine how a less supportive and empathetic therapist affects psychotherapy sessions.
Lower levels of these positive behaviors can lead to reduced patient engagement and a weaker therapist-patient relationship, potentially hindering therapy outcomes.
|
|
Other: Transcripts of real intervention sessions
This group consists of published transcripts of real intervention sessions, in which motivational interview techniques have been applied.
|
Motivational interviewing techniques as applied during the sessions on which the transcripts are based.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation's Accuracy in generating Psychotherapeutic Dialogues
Time Frame: 12 months
|
Assessment of the simulation's ability to accurately produce psychotherapeutic dialogues that adhere to the principles and techniques of motivational interviewing (MI), as determined by the average global scores of the Motivational Interviewing Treatment Integrity (MITI) code 4.2.
The MITI code 4.2 includes various subscales, such as empathy and MI spirit, each scored on a scale from 1 to 5, with lower scores suggesting a need for improvement in MI delivery, while higher scores reflect stronger therapeutic skills and better patient outcomes.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Errors/Deviations
Time Frame: 12 months
|
The number of errors or deviations from expected psychotherapeutic practices is counted, providing a quantitative measure of simulation quality.
This measure also serves as exclusion criteria from any other assessment.
|
12 months
|
|
Metric of Verbal Content (Therapist)
Time Frame: 12 months
|
Assessment of the text metrics of the therapist, based on the number of sentences, words, syllables, characters, and lexical diversity.
|
12 months
|
|
Metric of Verbal Content (Patient)
Time Frame: 12 months
|
Assessment of the text metrics of the patient, based on the number of sentences, words, syllables, characters, and lexical diversity.
|
12 months
|
|
Turn-takings
Time Frame: 12 months
|
Assessment of the turn-takings, based on the number of exchanges between the therapist and patient within a session, indicating the dynamic interaction flow.
|
12 months
|
|
Improvement of Patient
Time Frame: 12 months
|
Improvement of the patient is evaluated using an an observer-rated, circularly framed version of the Importance and Confidence Rulers, measuring the simulated patient's psychotherapeutic progress on a circular scale from 0 to 10. Lower scores indicate lower perceived importance or confidence, while higher scores suggest greater perceived importance or confidence in making the change.
|
12 months
|
|
Credibility of Patient Behavior
Time Frame: 12 months
|
The credibility of the patient's behavior is estimated using a 0 to 10 scale indicating how likely the evaluator found that the participants are real humans or simulations, offering insight into the perceived authenticity of the simulated interactions.
The credibility of the 8 real-world transcripts served as a comparison baseline/benchmark for this evaluation.
Lower scores indicate lower authenticity of the patient large-language model's (LLM's) simulated behavior, while higher scores suggest higher authenticity of the patient LLM's simulated behavior.
|
12 months
|
|
Credibility of Therapist Behavior
Time Frame: 12 months
|
The credibility of the therapist's behavior is estimated using a 0 to 10 scale indicating how likely the evaluator found that the participants are real humans or simulations, offering insight into the perceived authenticity of the simulated interactions.
The credibility of the 8 real-world transcripts served as a comparison baseline/benchmark for this evaluation.
Lower scores indicate lower authenticity of the therapist large-language model's (LLM's) simulated behavior, while higher scores suggest higher authenticity of the therapist LLM's simulated behavior.
|
12 months
|
|
Manipulation Check
Time Frame: 12 months
|
The implemented level of psychotherapeutic common factors by the therapist-LLM is approximated using the Therapist Empathy Scale (TES) as rough manipulation checks.
The TES rates the therapist's ability to understand and share a patient's feelings on a scale from 1 to 7. Higher scores indicate greater empathy, reflecting a stronger connection and understanding of the patient's emotions, while lower scores suggest less empathy.
|
12 months
|
|
Manipulation Check
Time Frame: 12 months
|
The implemented level of psychotherapeutic common factors by the therapist-LLM is approximated using the Working Alliance Inventory Short Observer form (WAI-S-O) as rough manipulation checks.
The Working Alliance Inventory uses 12 items evaluating the perceived therapeutic alliance between the patient and the therapist on a scale of 1 to 7.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gunther Meinlschmidt, Prof. Dr., University Hospital and University of Basel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-00000; th24Meinlschmidt
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.
Clinical Trials on Mental Disorder
-
Vincent AgyapongNova Scotia Health Authority; Dalhousie UniversityRecruitingGeneralized Anxiety Disorder | Major Depressive Disorder | Mental Health Wellness 1Canada
-
Otsuka Pharmaceutical Development & Commercialization...CompletedSchizophrenia | Major Depressive Disorder | Mental Disorder | Bipolar I DisorderUnited States
-
Brigham and Women's HospitalActive, not recruitingDepression | Mood Disorders | Depressive Disorder, Major | Psychiatric Disorder | Mental DisorderUnited States
-
Queen's UniversityCompleted
-
University of ManchesterRecruitingADHD | Mental Health | Autism | Neurodevelopment | Depression - Major Depressive Disorder | Anxiety Disorder (Panic Disorder or GAD)United Kingdom
-
Brigham and Women's HospitalActive, not recruitingDepression | PTSD | Mood Disorders | Anxiety Disorders | OCD | Major Depressive Disorder | Psychiatric Disorder | Mental DisorderUnited States
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
University of OuluCompletedSeasonal Affective Disorder (SAD)Finland
-
University of AmsterdamAcademic Center for Trauma and PersonalityActive, not recruitingMajor Depressive Disorder | Persistent Depressive DisorderNetherlands
Clinical Trials on High Levels of Common Therapeutic Factors
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)UnknownLymphedema | Stage II Uterine Corpus Cancer | Stage IVB Vulvar Cancer | Stage IA Uterine Corpus Cancer | Stage IB Uterine Corpus Cancer | Stage IA Cervical Cancer | Stage IB Cervical Cancer | Stage II Vulvar Cancer | Stage IIA Cervical Cancer | Stage IA Vulvar Cancer | Stage IB Vulvar Cancer | Stage IIIA Vulvar... and other conditionsUnited States
-
Lund UniversityCompletedObesity | Metabolic SyndromeSweden
-
University of ValladolidUnknownMyocardial Infarction | Heart Valve Diseases | Acute Myocardial Infarction | Disorder; Heart, Functional, Postoperative, Cardiac SurgerySpain
-
Consorci Sanitari de l'Alt Penedès i GarrafNot yet recruitingAcute DiseaseSpain
-
Zimmer BiometCompletedRheumatoid Arthritis | Inflammatory Arthritis | Osteoarthritis, Hip | Avascular Necrosis of Hip | Post-traumatic; ArthrosisGermany
-
The Mediterranean Institute for the Advance of...Carlos III Health Institute; European Regional Development Fund; Andalusian Regional... and other collaboratorsNot yet recruitingDepression | Anxiety | Prevention | m-HealthSpain
-
National Institute of Nutrition and Seafood Research...Haukeland University HospitalCompleted
-
Sun Yat-sen UniversityRecruitingHepatocellular CarcinomaChina
-
University of Alabama at BirminghamNational Cancer Institute (NCI)Withdrawn
-
National Institutes of Health Clinical Center (CC)National Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States