An interventional study of Imagery Rescripting Intervention (AI-Generated) in Generalized Anxiety, Fear of Failure and Rumination, sponsored by University of Social Sciences and Humanities, Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by University of Social Sciences and Humanities, Warsaw · Not applicable, Interventional, and Basic science
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 80 is close to the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →University of Social Sciences and Humanities, Warsaw is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During experiment/intervention (Day 1)
Therapist Ratings of Script Quality
A panel of cognitive-behavioral therapists will rate the AI-generated and manually created scripts on a 10-point Likert scale ranging from 1 to 20, for therapeutic quality, coherence, and emotional relevance. Higher scores will indicate higher quality/coherence/emotional relevance. Average therapist ratings will be used to test hypotheses about the acceptability of LLM-generated therapeutic content.
Time frame: Prior to intervention
Questionnaire on the Perceived Effectiveness and Appropriateness of Imagery-Based Intervention
A custom-developed questionnaire will be administered to participants in the experimental group to assess their subjective evaluation of the imagery rescripting intervention. The measure includes items evaluating emotional intensity, difficulty with imagery, resistance to memory modification, trust in the therapeutic process, realism of the experience, and other affective and cognitive responses. Items are rated on 5-point Likert scales and grouped into subscales representing common therapeutic barriers and facilitators. Each subscale ranges from 4 to 20, with a higher score indicating a higher problem with imagery techniques. The total and subscale scores will be analyzed to explore which factors are associated with intervention acceptance and perceived effectiveness.
Time frame: Post-intervention (Day 1)
TAPS Tool - Substance Use Screening
The Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) will be used to screen for problematic substance use. The self-report version of the TAPS consists of two parts: (1) past 12-month use of tobacco, alcohol, illicit drugs, and prescription medication for non-medical use. Scores will range from 1 (never) to 5 (every day/almost every day), with higher scores indicating a greater frequency of substance use. Scores will be used to exclude participants with probable substance use disorders, in line with the study's eligibility criteria.
Time frame: Screening only
Post-Traumatic Stress Symptoms Scale (DSM)
Self-report scale assessing PTSD symptoms as defined by DSM-5 criteria. The instrument includes 10 items evaluating symptom frequency over the previous 7 days on a 0-4 Likert scale. Total scores range from 0 to 40.
Time frame: Screening only
Working Alliance Inventory - Short Revised
The Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item self-report measure assessing the perceived quality of the therapeutic alliance across three subscales: Goal, Task, and Bond. Each subscale ranges from 4 to 20, with a higher score indicating a higher level of working alliance factors. General scores range from 12 to 60, with a higher score indicating a higher level of working alliance. In this study, the WAI-SR was adapted to assess participants' sense of connection and alliance with the AI-delivered intervention (e.g., the rescripting script and voice used). Scores will be used to explore whether the subjective sense of alliance predicts perceived effectiveness, emotional impact, or response to the intervention.
Time frame: Post-intervention (Day 1)
Beck Depression Inventory
The Beck Depression Inventory, Second Edition (BDI-II), is a 21-item self-report questionnaire assessing the severity of depressive symptoms, with total scores ranging from 0 to 63. Higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was administered at screening to assess baseline depressive symptoms. While not used as a formal outcome variable, BDI-II scores may be included in exploratory analyses to examine their potential moderating effects on emotional responses or intervention acceptance.
Time frame: Screening only
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Started Jun 2025 (actual). Primary completion is estimated for Nov 2025, 5 months after the start.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 5 months is below that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
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University of Social Sciences and Humanities, Warsaw