NCT07565714

Brief Summary

The aim of the study is to examine the effect of imagery rescripting (ImRs) in the context of utilizing large language models (LLMs). Intervention will involve the prior presentation of the most aversive fragment of the memory, the so-called 'hotspot.' This intervention will allow for the replication of the effect described by Dibbets and Arntz (2016), according to which the prior activation of the most emotional element of a memory enhances the effectiveness of ImRs. The study is also significant due to another ongoing study in which a substantial number of participants have already been examined; however, due to the exhaustion of funds, it was not possible to utilize the remainder of the recruited sample. Investigating an additional condition will allow for a more complete utilization of the available participant pool and significantly increase the project's scientific value by comparing the traditional ImRs mechanism with its AI-generated version.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress40%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Fear of FailureIntrusive Autobiographical MemoriesGeneralized AnxietyImagery RescriptingAI

Outcome Measures

Primary Outcomes (5)

  • Generalized Anxiety Disorder DSM Scale (GAD)

    DSM Scale (Craske et al., 2013, own translation); brief dimensional self-rating questionnaire for generalized anxiety disorder (American Psychiatric Association, 2013, Polish translation: translation made by the authors using a standard back-translation method, 2020). Scale consists of 10 items relating to the thoughts, feelings, and behaviors the subjects have experienced in the last 7 days. The answers are marked on a 4-point Likert scale (0=never, 4=all the time), with scores ranging 0-4.

    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 (1)

ImRs AI

EXPERIMENTAL

Participants 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

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.

ImRs AI

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Poznan, Wielkopolska, 61-619, Poland

RECRUITING

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

Poznan, Wielkopolska, 61-619, Poland

RECRUITING

Related Publications (12)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.</citation> <pubmed_id>12847779

    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.</citation> <pubmed_id>21082446

    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
  • 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
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    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.

    BACKGROUND
  • 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

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
NA
Masking
NONE
Masking Details
Participants were informed that the study investigated the use of imagery-based techniques, but they were not informed about the specific condition of material beeing generated by AI. 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
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant and Lecturer

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

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