NCT07189715

Brief Summary

This pilot randomized controlled trial will investigate the feasibility and effectiveness of using generative artificial intelligence to create personalized therapeutic scripts for imagery rescripting (ImRs). Eighty participants will listen to autobiographical scenarios based on their own memories of childhood criticism and neutral events. The scenarios will be generated by the Gemini large language model and reviewed by trained experimenters. On Day 1, all participants will be exposed to both critical and neutral scenarios and randomly assigned to either an experimental group receiving an ImRs intervention or a control group receiving no therapeutic modification. Skin conductance and subjective emotional ratings will be collected during the session, with follow-up questionnaires administered one week later. In addition, cognitive-behavioral therapists will evaluate the quality of the generated scripts. The study aims to assess emotional and physiological responses to AI-generated content, compare outcomes between groups, and explore the potential of large language models in scalable psychological interventions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 24, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

August 18, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Fear of FailureIntrusive Autobiographical MemoriesGeneralized AnxietyImagery RescriptingAI

Outcome Measures

Primary Outcomes (5)

  • Generalized Anxiety Disorder Scale (GAD-7)

    The Generalized Anxiety Disorder 7-item scale (GAD-7) will be used to assess self-reported anxiety. Scores range from 0 to 21; higher scores indicate a higher level of generalized anxiety symptoms. Scores will be collected before the intervention and one week later to measure change in general anxiety levels following exposure to either AI-based ImRs or control scripts.

    Screening, Pre-intervention (Day 1) and 1-week follow-up

  • The Performance Failure Appraisal Inventory

    The Performance Failure Appraisal Inventory was used to assess fear of failure. It is a 25-item questionnaire that measures the strength of subjective beliefs about the consequences of failure. The PFAI has five subscales: fear of experiencing shame and embarrassment; fear of devaluing one's self-esteem; fear of having an uncertain future; fear of important others losing interest; and fear of upsetting important others. PFAI score ranges from 35 to 175, with higher scores indicating a higher level of fear of failure.

    Pre-intervention (Day 1)

  • Intrusive Thought Frequency (Rumination Inventory - adapted)

    A modified version of the Event-Related Rumination Inventory will be used to assess the frequency and intrusiveness of thoughts related to the autobiographical criticism memories. The scale includes both intrusive and reflective rumination items, ranging from 20 to 80, with higher scores indicating a higher level of event-related rumination. Change in scores between baseline and follow-up will serve as an index of the cognitive impact of the intervention.

    Pre-intervention (Day 1) and 1-week follow-up

  • Skin Conductance Level (SCL)

    Electrodermal activity will be recorded continuously during the presentation of autobiographical scenarios to assess physiological arousal. The SCL signal will be analyzed during the baseline, critical, and neutral conditions, as well as during the imagery rescripting (ImRs) intervention (experimental group only). Data will be used to examine whether AI-generated criticism scripts elicit arousal.

    During experiment/intervention (Day 1)

  • Emotional Response Ratings (Subjective)

    Participants will rate the intensity of emotional reactions (fear, sadness, arousal, etc.) using Likert scales after each presented scenario. Scores will range from 1 to 10, with higher scores indicating a more intense emotional reaction. These ratings will help determine emotional engagement and compare affective response between criticism and neutral content, as well as between groups.

    During experiment/intervention (Day 1)

Secondary Outcomes (5)

  • Therapist Ratings of Script Quality

    Prior to intervention

  • Questionnaire on the Perceived Effectiveness and Appropriateness of Imagery-Based Intervention

    Post-intervention (Day 1)

  • TAPS Tool - Substance Use Screening

    Screening only

  • Post-Traumatic Stress Symptoms Scale (DSM)

    Screening only

  • Working Alliance Inventory - Short Revised

    Post-intervention (Day 1)

Other Outcomes (1)

  • Beck Depression Inventory

    Screening only

Study Arms (2)

AI-Based Imagery Rescripting Intervention

EXPERIMENTAL

Participants in this group listened to personalized audio scripts based on their own childhood memories of parental criticism and neutral events. All participants heard both critical and neutral scenarios. At the end of the session, one critical scenario was presented in a modified version that included an imagery rescripting (ImRs) intervention, in which a therapist figure entered the imagined scene and addressed the child's unmet needs. All scripts were generated by the Gemini large language model and reviewed by experimenters. Participants rated their emotional responses and underwent continuous skin conductance recording during the session. Follow-up assessments were conducted one week later.

Behavioral: Imagery Rescripting Intervention (AI-Generated)

Control Condition (No Rescripting)

NO INTERVENTION

Participants in this group listened to personalized audio scripts based on their own childhood memories of parental criticism and neutral events. All participants heard both types of scenarios, but none of the critical scenarios were modified or rescripted. Scripts were generated by the Gemini large language model and reviewed by experimenters. Participants rated their emotional responses and underwent continuous skin conductance recording during the session. Follow-up assessments were conducted one week later.

Interventions

Participants listened to a series of personalized audio scenarios based on their childhood memories of parental criticism and neutral events. At the end of the session, one critical scenario was presented in a modified version that included a therapeutic imagery rescripting (ImRs) intervention. In this script, a therapist figure entered the scene and addressed the child's unmet needs, following the standard rescripting format. The scripts were generated using the Gemini large language model and reviewed by trained experimenters to ensure coherence and therapeutic validity. The intervention aimed to reduce distress and intrusive thoughts related to the memory.

AI-Based Imagery Rescripting Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35
  • Score ≥ 8 on GAD-7 (Plummer et al., 2016)
  • Ability to recall at least two childhood memories involving parental criticism

You may not qualify if:

  • History of prolonged physical or sexual abuse
  • Current psychotherapy or psychopharmacology
  • PTSD diagnosis (DSM-5 screening)
  • Substance abuse (TAPS tool)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SWPS University (University of Social Sciences and Humanities); Poznań Laboratory of Affective Neuroscience

Poznan, Wielkopolska, 61-719, Poland

RECRUITING

Related Publications (12)

  • Yao, Y., Duan, J., Xu, K., Cai, Y., Sun, Z., & Zhang, Y. (2024). A survey on large language model (llm) security and privacy: The good, the bad, and the ugly. High-Confidence Computing, 100211

    BACKGROUND
  • Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.

    PMID: 26719105BACKGROUND
  • Leyton F, Olhaberry M, Moran J, De la Cerda C, Leon MJ, Sieverson C, Alfaro A, Hernandez C, Alvardo R, Steele H. Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Trials. 2021 Oct 30;22(1):754. doi: 10.1186/s13063-021-05668-w.

    PMID: 34717750BACKGROUND
  • LeBeau R, Mischel E, Resnick H, Kilpatrick D, Friedman M, Craske M. Dimensional assessment of posttraumatic stress disorder in DSM-5. Psychiatry Res. 2014 Aug 15;218(1-2):143-7. doi: 10.1016/j.psychres.2014.03.032. Epub 2014 Apr 5.

    PMID: 24746390BACKGROUND
  • Dibbets P, Arntz A. Imagery rescripting: Is incorporation of the most aversive scenes necessary? Memory. 2016;24(5):683-95. doi: 10.1080/09658211.2015.1043307. Epub 2015 Jun 15.

    PMID: 26076101BACKGROUND
  • Conroy, D. E. (2001). Progress in the development of a multidimensional measure of fear of failure: The Performance Failure Appraisal Inventory (PFAI). Anxiety, Stress and Coping, 14(4), 431-452.

    BACKGROUND
  • Arntz, A. (2012). Imagery rescripting as a therapeutic technique: Review of clinical trials, basic studies, and research agenda. Journal of Experimental Psychopathology, 3(2), 189-208.

    BACKGROUND
  • Cann A, Calhoun LG, Tedeschi RG, Triplett KN, Vishnevsky T, Lindstrom CM. Assessing posttraumatic cognitive processes: the Event Related Rumination Inventory. Anxiety Stress Coping. 2011 Mar;24(2):137-56. doi: 10.1080/10615806.2010.529901.

    PMID: 21082446BACKGROUND
  • Busseri MA, Tyler JD. Interchangeability of the Working Alliance Inventory and Working Alliance Inventory, Short Form. Psychol Assess. 2003 Jun;15(2):193-7. doi: 10.1037/1040-3590.15.2.193.

    PMID: 12847779BACKGROUND
  • Mossman SA, Luft MJ, Schroeder HK, Varney ST, Fleck DE, Barzman DH, Gilman R, DelBello MP, Strawn JR. The Generalized Anxiety Disorder 7-item scale in adolescents with generalized anxiety disorder: Signal detection and validation. Ann Clin Psychiatry. 2017 Nov;29(4):227-234A.

    PMID: 29069107BACKGROUND
  • McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O'Grady KE, Bouk LB, Cushing C, King J, Wahle A, Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Nov 15;165(10):690-699. doi: 10.7326/M16-0317. Epub 2016 Sep 6.

    PMID: 27595276BACKGROUND
  • Bradley MM, Sambuco N, Lang PJ. Imagery, emotion, and bioinformational theory: From body to brain. Biol Psychol. 2023 Oct;183:108669. doi: 10.1016/j.biopsycho.2023.108669. Epub 2023 Aug 28.

    PMID: 37648076BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderRumination Syndrome

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Officials

  • Stanisław Karkosz, MA

    SWPS University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanisław Karkosz, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were informed that the study investigated the use of imagery-based techniques, but they were not informed about the specific condition to which they were assigned (experimental vs. control). The study employed partial masking to reduce expectancy effects while maintaining ethical transparency regarding the general purpose of the study.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 24, 2025

Study Start

June 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

September 24, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including questionnaire scores, psychophysiological measures, and outcome ratings) will be made available upon reasonable request, beginning 6 months after publication and for a period of 5 years. Access will be granted for non-commercial research purposes only, upon approval of a data access proposal and, where applicable, institutional ethics clearance.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available after publication and for up to 5 years.
Access Criteria
Requests should be submitted to the principal investigator (skarkosz@swps.edu.pl) and include a brief project description and intended use of data. Approved requests will receive access via a secure data repository or encrypted transfer.

Locations