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临床试验/NCT07565714
NCT07565714招募中不适用

Optimization of Late Imagery Rescripting Research Using Generative Artificial Intelligence

University of Social Sciences and Humanities, Warsaw2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Generalized Anxiety Disorder DSM Scale (GAD)

研究概览

简要总结

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.

详细描述

This pilot randomized controlled trial will explore the application of large language models (LLMs) in the development of personalized therapeutic interventions. The study will focus on the emotional and psychophysiological effects of listening to autobiographical scenarios based on participants' childhood experiences of parental criticism. All participants will be asked to recall and describe two critical and two neutral childhood memories. Based on this input, personalized scripts will be generated using Gemini, a large language model. Each script will be reviewed and, if necessary, modified by trained experimenters to ensure therapeutic coherence and alignment with imagery rescripting (ImRs) principles. On Day 1, all participants will listen to critical personalized scenarios during the laboratory session. The experimental group will listen to modified versions of the critical memory scripts, in which a therapist figure will intervene to address the child's unmet needs-an application of imagery rescripting. To assess physiological arousal, skin conductance will be continuously recorded throughout the session. After each scenario, participants will rate their emotional intensity and specific feelings (e.g., fear, sadness) on Likert scales. The group will receive the ImRs intervention after the initial scenario phase. One week later, all participants will complete follow-up questionnaires assessing generalized anxiety (GAD-7) and the frequency of intrusive thoughts related to the memories. In addition, a panel of licensed cognitive-behavioral therapists will evaluate the generated scenarios for therapeutic quality. Their feedback will be used to assess the acceptability and coherence of AI-assisted therapeutic scripts. The study will test the feasibility of using LLM-generated content in clinical settings and aims to determine whether such interventions can reduce distress and intrusiveness while eliciting measurable emotional and physiological responses

Hypotheses:

The criticism scenarios generated by the model will elicit fearful responses in all participants.

The level of fearful reaction evoked by the AI-generated criticism scenarios will correlate with participants' baseline fear of failure.

Participants in the ImRs group will report fewer intrusive thoughts and lower generalized anxiety levels one week after the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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. (?)

干预措施: Imagery Rescripting Intervention (Behavioral)

结局指标

主要结局

Generalized Anxiety Disorder DSM Scale (GAD)

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

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.

The Performance Failure Appraisal Inventory

时间窗: Pre-intervention (Day 1)

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.

Intrusive Thought Frequency (Rumination Inventory - adapted)

时间窗: Pre-intervention (Day 1) and 1-week follow-up

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.

Skin Conductance Level (SCL)

时间窗: During experiment/intervention (Day 1)

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.

Emotional Response Ratings (Subjective)

时间窗: During experiment/intervention (Day 1)

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.

次要结局

  • 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))

研究者

发起方
University of Social Sciences and Humanities, Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanisław Karkosz

Research Assistant and Lecturer

University of Social Sciences and Humanities, Warsaw

研究点 (2)

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