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Идёт набор NCT07189715

Optimization of Imagery Rescripting Research Using Generative Artificial Intelligence

Без фазы С лечением Generalized Anxiety Fear of Failure Rumination

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Imagery Rescripting Intervention (AI-Generated).
Кому может быть актуально
Состояния в реестре: Generalized Anxiety, Fear of Failure, Rumination. Базовые параметры: 18 лет — 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

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 experimental 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 AI-generated scripts will be positively evaluated by cognitive-behavioral therapists, with an average rating above 6 out of 10.

The therapist ratings of the AI-generated scripts will not significantly differ from those of human-written scripts based on clinical interviews used in prior research.

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

The level of anxiety 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 compared to the control group.

Вмешательства

  • Поведенческое Imagery Rescripting Intervention (AI-Generated)
    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

Первичные конечные точки

  • Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Screening, Pre-intervention (Day 1) and 1-week follow-up]
  • The Performance Failure Appraisal Inventory [Срок оценки: Pre-intervention (Day 1)]
  • Intrusive Thought Frequency (Rumination Inventory - adapted) [Срок оценки: Pre-intervention (Day 1) and 1-week follow-up]
  • Skin Conductance Level (SCL) [Срок оценки: During experiment/intervention (Day 1)]
  • Emotional Response Ratings (Subjective) [Срок оценки: During experiment/intervention (Day 1)]
Вторичные конечные точки (5)
  • Therapist Ratings of Script Quality [Срок оценки: Prior to intervention]
  • Questionnaire on the Perceived Effectiveness and Appropriateness of Imagery-Based Intervention [Срок оценки: Post-intervention (Day 1)]
  • TAPS Tool - Substance Use Screening [Срок оценки: Screening only]
  • Post-Traumatic Stress Symptoms Scale (DSM) [Срок оценки: Screening only]
  • Working Alliance Inventory - Short Revised [Срок оценки: Post-intervention (Day 1)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Польша · 1 центр
  • SWPS University (University of Social Sciences and Humanities); Poznań Laboratory of Affec — Poznan

Публикации

  • 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
  • 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 26719105
  • 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 34717750
  • 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 24746390
  • 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 26076101
  • 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.
  • 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.
  • 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 21082446

Идентификаторы

NCT: NCT07189715 · 104/2024/FRBN/G

Первоисточники (государственные реестры)

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