Generalized AnxietyFRBNNCT07189715
Optimization of Imagery Rescripting Research Using Generative Artificial Intelligence
A study testing Imagery Rescripting Intervention (AI-Generated) in people with Generalized Anxiety and Fear of Failure, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Generalized Anxiety, Fear of Failure, Rumination
- What is being tested?
- Imagery Rescripting Intervention (AI-Generated)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-35
- Score ≥ 8 on GAD-7 (Plummer et al., 2016)
- Ability to recall at least two childhood memories involving parental criticism
Who cannot join
- History of prolonged physical or sexual abuse
- Current psychotherapy or psychopharmacology
- PTSD diagnosis (DSM-5 screening)
- Substance abuse (TAPS tool)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
SWPS University (University of Social Sciences and Humanities); Poznań Laboratory of Affective Neuroscience
Poznan, Wielkopolska, 61-719
Stanisław Karkosz, MA, 570 668 996 ext. +48, skarkosz@swps.edu.pl
About this study
Official title: A Randomized Controlled Pilot Study on AI-Based Imagery Rescripting for Childhood Criticism Memories
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.
Read the detailed description
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.
- Conditions
- Generalized Anxiety, Fear of Failure, Rumination
- Being tested
- Imagery Rescripting Intervention (AI-Generated)
- Keywords
- Fear of Failure, Intrusive Autobiographical Memories, Generalized Anxiety, Imagery Rescripting, AI
- Medical subject headings
- Generalized Anxiety Disorder, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rescripting Intervention (AI-Generated)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Imagery Rescripting Intervention | Experimental | 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. Receives: Behavioral: Imagery Rescripting Intervention (AI-Generated) |
| Control Condition (No Rescripting) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During experiment/intervention (Day 1)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Generalized AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanisław Karkosz, MA, Principal investigator, SWPS University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189715
- Sponsor's protocol ID
- 104/2024/FRBN/G
- Acronym
- FRBN
- Status last verified
- May 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 26719105Leyton 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.
PubMed 34717750LeBeau 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.
PubMed 24746390Dibbets 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.
PubMed 26076101Conroy, 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.
PubMed 21082446Busseri 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.
PubMed 12847779Mossman 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.
PubMed 29069107McNeely 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.
PubMed 27595276Bradley 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.
PubMed 37648076
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study on AI-Based Imagery Rescripting for Childhood Criticism Memories
- ClinicalTrials.gov ID
- NCT07189715
- Acronym / sponsor ID
- FRBN / 104/2024/FRBN/G
- Conditions
- Generalized Anxiety, Fear of Failure, Rumination
- Keywords
- Fear of Failure, Intrusive Autobiographical Memories, Generalized Anxiety, Imagery Rescripting, AI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Based Imagery Rescripting Intervention | Experimental | 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 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. |
| Control Condition (No Rescripting) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-35
- Score ≥ 8 on GAD-7 (Plummer et al., 2016)
- Ability to recall at least two childhood memories involving parental criticism
Key exclusion criteria (4 listed)
- History of prolonged physical or sexual abuse
- Current psychotherapy or psychopharmacology
- PTSD diagnosis (DSM-5 screening)
- Substance abuse (TAPS tool)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 reviewed by trained experimenters to ensure coherence and therapeutic validity. The intervention aimed to reduce distress and intrusive thoughts related to the memory. | Behavioural | AI-Based Imagery Rescripting Intervention |
Primary outcome
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Therapist Ratings of Script Quality
Time frame: Prior to intervention
Questionnaire on the Perceived Effectiveness and Appropriateness of Imagery-Based Intervention
Time frame: Post-intervention (Day 1)
TAPS Tool - Substance Use Screening
Time frame: Screening only
Post-Traumatic Stress Symptoms Scale (DSM)
Time frame: Screening only
Working Alliance Inventory - Short Revised
Time frame: Post-intervention (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- BackgroundYao, 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: PubMed 26719105Plummer 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: PubMed 34717750Leyton 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: PubMed 24746390LeBeau 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: PubMed 26076101Dibbets 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.
- BackgroundConroy, 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.
- BackgroundArntz, 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: PubMed 21082446Cann 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.
- Background: PubMed 12847779Busseri 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.
- Background: PubMed 29069107Mossman 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: PubMed 27595276McNeely 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: PubMed 37648076Bradley 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stanisław Karkosz, MA principal investigator
SWPS University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rescripting Intervention (AI-Generated) in people with Generalized Anxiety and Fear of Failure, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanisław Karkosz, MA (+48 570 668 996, skarkosz@swps.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Scale (GAD-7) (time frame: Screening, Pre-intervention (Day 1) and 1-week follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07189715, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.