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临床试验/NCT07189715
NCT07189715招募中不适用

A Randomized Controlled Pilot Study on AI-Based Imagery Rescripting for Childhood Criticism Memories

University of Social Sciences and Humanities, Warsaw2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Generalized Anxiety Disorder Scale (GAD-7)

研究概览

简要总结

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.

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 and neutral events.

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 both critical and neutral personalized scenarios during the laboratory session. Participants will be randomly assigned to one of two groups:

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.

The control group will listen to the same autobiographical content without any therapeutic intervention or modification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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 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.

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)

结局指标

主要结局

Generalized Anxiety Disorder Scale (GAD-7)

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

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.

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
Sponsor

研究点 (2)

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