Fear of FailureNCT06537284
Comparison of Imagery Rescripting With and Without Reconsolidation Disruption
A study testing ImRs-DSR and ImRs in people with Fear of Failure, run by Jaroslaw Michalowski at 1 site in Poland.
Trial summary
This clinical trial compares the effects of Imagery Rescripting intervention with and without memory reconsolidation disruption procedure (ImRs-DSR and ImRs accordingly), to provide evidence for the superiority of the ImRs-DSR. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Failure
- What is being tested?
- ImRs-DSR and ImRs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults aged 18-35
- high fear of failure
- not currently undergoing psychotherapy or psychopharmacotherapy
- no severe punitive experiences in the past
Who cannot join
- current severe affective disorders
- current severe anxiety
- current severe personality disorders
- active suicidality
- psychosis
- substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Imagery Rescripting With and Without Reconsolidation Disruption
This clinical trial compares the effects of Imagery Rescripting intervention with and without memory reconsolidation disruption procedure (ImRs-DSR and ImRs accordingly), to provide evidence for the superiority of the ImRs-DSR. Tested effects include a decrease in psychophysiological (Skin Conductance Level, Salivary alpha amylase) and subjective (questionnaires \& rating) measures in response to imagery scenarios of criticism after 2 weeks of intervention, at 3 \& 6-month follow-ups; also, procedures from basic behavior studies (spontaneous recovery, renewal, reinstatement) will be tested; also, generalizability for the imagery of past criticism scenario that wasn't undergoing intervention \& novel scenario of future criticism (which would be presented at post-treatment, but not at pre-treatment session) will be tested. The scientific team will recruit a subclinical sample of 48 subjects per group (aiming for the recruitment of 67 subjects due to the high drop-out ratio).
Read the detailed description
The primary objective of this randomized controlled trial is to compare the Imagery Rescripting intervention with and without memory reconsolidation disruption procedure (ImRs-DSR and ImRs accordingly), to provide evidence for the superiority of the ImRs-DSR on a subclinical sample of at least 96 participants (planned recruitment involves 134 participants to accommodate for drop-outs). Investigators plan to test intervention efficacy by measuring response to imagery scenarios of criticism based on interviews with therapists, conducted before the start of the experiment.
The study uses a 2 x 8 mixed factorial design with two interventions (Imagery Rescripting with and without memory reconsolidation disruption), and 8 time points (pre-treatment (time point 1, TP1), 4 intervention sessions (TP2-TP5), post-treatment after 2 weeks of intervention (TP6), 3- and 6-month follow up (TP7, TP8)). The primary intervention lasts 2 weeks and involves 4 intervention sessions.
In terms of hypotheses, investigators expect that the two-week treatment will result in a stable reduction in subjective and physiological measures of emotional distress related to criticism/failure and ImRs-DSR will be more effective than ImRs in achieving this stability. Herewith, investigators expect that psychophysiological response (sAA and SCL) to the imagery of an autobiographical scenario of being criticized that is used for treatment would drop after treatment when investigated in a familiar context in both groups (H1), and the change will be more pronounced in the superior, i.e. ImRs-DSR group (H2). Investigators hypothesize that after treatment, subjective ratings of negative emotional experience during the treated criticism scenario would also be smaller than before in both groups (H3), however, the decrease will be higher in ImRs-DSR (H4). Investigators also hypothesize that similar effects as those defined in H1 and H3 will be also observed after the presentation of the most aversive part of the scenario (hotspot) i.e. at reinstatement (H5) and that they will be more pronounced in ImRs-DSR (vs ImRs) group (H6). According to our assumptions investigators expect that changes achieved after rescripting one criticism-related scenario in a specific context will generalize to other scenarios (i.e. imagining of untreated past criticism or future criticism scenarios, see Imagery stimuli \& interventions section) (H7) and other contexts such as imaging the treated scenario in an unknown room (i.e. renewal) (H8) or various situations verified by PFAI (H9), however, this generalizability will be higher in the ImRs-DSR group with regard to other scenarios (H10), renewal (H11) and PFAI scores (H12). Investigators expect that the changes in reaction (presented in H1, H3, H5, H7, H8, and H9) will be observed after 3 and 6 months (H13), however, a higher decrease will be observed in the ImRs-DSR group (H14).
Primary and secondary outcomes are assessed for criticism-related scenarios using psychophysiology (Skin Conductance Level at pre-, during, and post-treatment, as well as during 3- and 6-month follow-up; Salivary Alpha-Amylase at pre- and post-treatment) and subjective data (online questionnaires and rating, at screening, pre-, during, post-treatment, as well as during 3- and 6-month follow up). Investigators plan to use spontaneous recovery, renewal, and reinstatement procedures to test the efficacy (stability and generalizability) of the studied interventions. For generalizability investigators also plan to test reactions to various imagery scenarios of criticism (un-treated criticism, future criticism). Investigators plan to use 3- and 6-month follow-ups to test long-term effects. Investigators plan to conduct analyses using 2 (arms) x 2 (time points) ANOVA models to check the intervention effects (TP1-TP6 short-term, TP1-TP7/TP8 long-term) on various procedures (spontaneous recovery, renewal, reinstatement). Additional analyses utilize standard NHST calculations and procedures (such as t-tests and correlation coefficients) alongside the conventional ⍺=.05 level.
Investigators plan to use the double-blind procedure, as neither therapists/experimenters will be informed about the arm (arms will be coded in the scripts), nor participants will be informed about conditions in the study, and the research hypotheses will be masked.
- Conditions
- Fear of Failure
- Being tested
- ImRs-DSR, ImRs
- Keywords
- Fear of failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImRs-DSRBehavioural
Imagery Rescripting with Memory Reconsolidation Disruption
ImRsBehavioural
Imagery Rescripting regular
| Study group | Role | What they receive |
|---|---|---|
| Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR) | Experimental | Before treatment each participant took part in two imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall three events of being criticized for failures (2 past and 1 future events). The treatment scenario involved memory anticipation (similarly framed for all scenarios) that required recalling three images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
After 10 minute break (reconsolidation disruption window) the imagery of the critic was followed by the rescripting part, in which: 1) the therapist enters the scene and prevents the criticism 2) the therapist addresses a critic and points out the child's needs 3) the therapist addresses the child and acknowledges its needs 4) the therapist suggests to the child to perform an activity that would meet its needs. Receives: Behavioral: ImRs-DSR |
| Imagery Rescripting regular (ImRs) | Active comparator | Before treatment each participant took part in two imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall three events of being criticized for failures (2 past and 1 future events). The treatment scenario involved memory anticipation (similarly framed for all scenarios) that required recalling three images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
Immediately after the imagery of the critic the rescripting part was presented, in which: 1) the therapist enters the scene and prevents the criticism 2) the therapist addresses a critic and points out the child's needs 3) the therapist addresses the child and acknowledges its needs 4) the therapist suggests to the child to perform an activity that would meet its needs. Receives: Behavioral: ImRs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Performance Failure Appraisal Inventory
The Performance Failure Appraisal Inventory (PFAI; Conroy, 2001, Polish translation: Golińska, 2017) was used to assess fear of failure. It is a 35-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, with scores ranging 35-175.
Measured: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Subjective ratings at the end of all sessions
Subjective ratings at the end of all sessions- participants were asked to evaluate each fragment of the presented scenarios according to several measures: immersion, focus, emotions (happiness, sadness, guilt, fear, anger, disgust) on a 9-point Likert scale (very low-very high), and valence (very negative-very positive), scores ranging 1-9 for each factor.
Measured: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
SCL recordings
Skin conductance level (SCL) was collected during the audio-guided scenarios' imagery at pre-treatment, treatment, post-treatment, and follow-up sessions. SCL was acquired using Biopack MP160 EDA-MRI system, with a sampling frequency of 2000Hz. The signal was resampled into 1000Hz, then smoothed with median (100 samples), and filtered with a high-passed 1Hz filter. We calculated normalized change in SCL with equation 100✕(SCLStim-SCLbaseline/SCLbaseline), where SCLStim is the mean signal value during the stimulus and SCLbaseline is an SCL reaction during the baseline preceding the first part in each scenario (Sugimine et al., 2020). Our primary outcome was SCL during the imagery of different scenarios, separated for anticipation and hotspot parts.
Measured: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Saliva sampling sAA
Saliva samples were collected on pre- and post-treatment with cotton rolls. Samples were collected using cotton rolls that were chewed for 1 min and were later secured in sterile V-bottom tubes and stored at 4°C temperature upon analysis. Samples were coded and sent to the Institute of Human Genetics Polish Academy of Science where the level of alpha amylase was measured.
Measured: Pre-Treatment (TP1), 2-weeks post-treatment (TP6)
Secondary outcomes (10)
Beck Depression Inventory
Beck Depression Inventory second edition (BDI-II; Beck, Steer, \& Brown, 2005; Polish translation: Łojek \& Stańczak, 2019) BDI-II is a self-report scale using 21 items regarding the presence and strength of depression symptoms, with scores ranging 0-63.
Measured: Screening, 6-month Follow-up
Yale-Brown Obsessive-Compulsive
Yale-Brown Obsessive-Compulsive self-report severity scale Y-BOCS-SR (Goodman et al., 1989; Polish translation: translation made by the authors using a standard back-translation method, 2020) a 10-item, self-report questionnaire created to evaluate OCD severity, scores ranging 0-40.
Measured: Screening, 6-month Follow-up
The Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test AUDIT (Saunders et al., 1993; Polish translation: Babor et al., 1998) is a self-reported tool containing 10 items used to assess recent alcohol consumption, alcohol dependence symptoms, and problems related to alcohol consumption, with scores ranging 0-40.
Measured: Screening, 6-month Follow-up
Drug Abuse Screen Test
Drug Abuse Screen Test DAST 10 (Skinner, 1982; Polish translation: translation made by the authors using a standard back-translation method, 2020) is a self-reported questionnaire to detect drug use disorders, scores ranging 0-10.
Measured: Screening, 6-month Follow-up
DSM Scales
DSM Scales (Craske et al., 2013, own translation); is a set of brief dimensional self-rating questionnaires for social anxiety disorder, agoraphobia, panic disorder, generalized anxiety disorder, and Post Traumatic Stress Symptoms (American Psychiatric Association, 2013, Polish translation: translation made by the authors using a standard back-translation method, 2020). Each 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.
Measured: Screening, 6-month Follow-up
Structured Clinical Interview for DSM-5 (SCID-5-PD)
Structured Clinical Interview for DSM-5 SCID-5-PD (First et al., 2016, Polish translation: Zawadzki, 2017) is a semistructured clinical interview that evaluates DSM-5 personality disorders under three clusters of A, B, and C, and other specific personality disorders. Based on positive answers to questions clinician diagnose adequate personality disorders.
Measured: Screening
M.I.N.I. Mini International Neuropsychiatric Interview
M.I.N.I. Mini International Neuropsychiatric Interview (Sheehan, et al., 1998, Polish translation: Masiak \& Przychoda, 1998) is a short structured interview for DSM IV and ICD 10 disorders, used to assess mental disorders: major depressive disorder, dysthymic disorder, suicidality, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol dependence/abuse, drug dependence/abuse, antisocial personality disorder. Based on positive answers to questions clinician diagnose adequate disorders.
Measured: Screening
Liebowitz Social Anxiety Scale
Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale to evaluate fear and avoidance in social situations such as social interaction, public speaking, being observed by others, eating and drinking in public, with scores ranging from 0 to 144.
Measured: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Pure Procrastination Scale
Pure Procrastination Scale (PPS; Steel, 2010; Polish adaptation by Cieciuch and Stępień, with alternations introduced by Stępień and Topolewska, 2014, pp. 152-154) is composed of 12 items, which measures three components of procrastination: decisional delay, implemental delay and delays in lateness/timeliness, with scores ranging 12-60.
Measured: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Frost Multidimensional Perfectionism Scale
Frost Multidimensional Perfectionism Scale (Frost MPS; Stöber, 1998; Polish translation: Piotrowski and Bojanowska, 2021) was used to assess overall perfectionism and its dimensions: Personal Standards, Organization, Concern Over Mistakes, Doubts About Actions, Parental Expectations, and Parental Criticism, with scores ranging 35-175.
Measured: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jun 2020
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Fear of FailureStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaroslaw Michalowski
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor-investigator, Jaroslaw Michalowski, University of Social Sciences and Humanities, Warsaw
- Investigators
- Jarosław Michałowski, PHD, Principal investigator, SWPS University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537284
- Sponsor's protocol ID
- SONATA_BIS_JM2019
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agren T, Engman J, Frick A, Bjorkstrand J, Larsson EM, Furmark T, Fredrikson M. Disruption of reconsolidation erases a fear memory trace in the human amygdala. Science. 2012 Sep 21;337(6101):1550-2. doi: 10.1126/science.1223006.
PubMed 22997340Arntz A, Weertman A. Treatment of childhood memories: theory and practice. Behav Res Ther. 1999 Aug;37(8):715-40. doi: 10.1016/s0005-7967(98)00173-9.
PubMed 10452174Conroy, D. E., Willow, J. P., & Metzler, J. N. (2002). Multidimensional fear of failure measurement: The performance failure appraisal inventory. Journal of applied sport psychology, 14(2), 76-90.
Morina N, Lancee J, Arntz A. Imagery rescripting as a clinical intervention for aversive memories: A meta-analysis. J Behav Ther Exp Psychiatry. 2017 Jun;55:6-15. doi: 10.1016/j.jbtep.2016.11.003. Epub 2016 Nov 9.
PubMed 27855298Schiller D, Kanen JW, LeDoux JE, Monfils MH, Phelps EA. Extinction during reconsolidation of threat memory diminishes prefrontal cortex involvement. Proc Natl Acad Sci U S A. 2013 Dec 10;110(50):20040-5. doi: 10.1073/pnas.1320322110. Epub 2013 Nov 25.
PubMed 24277809Siegesleitner M, Strohm M, Wittekind CE, Ehring T, Kunze AE. Improving imagery rescripting treatments: Comparing an active versus passive approach. J Behav Ther Exp Psychiatry. 2020 Dec;69:101578. doi: 10.1016/j.jbtep.2020.101578. Epub 2020 Jun 9.
PubMed 32569854Wild J, Clark DM. Imagery Rescripting of Early Traumatic Memories in Social Phobia. Cogn Behav Pract. 2011 Nov;18(4):433-443. doi: 10.1016/j.cbpra.2011.03.002.
PubMed 22298942Sugimine S, Saito S, Takazawa T. Normalized skin conductance level could differentiate physical pain stimuli from other sympathetic stimuli. Sci Rep. 2020 Jul 2;10(1):10950. doi: 10.1038/s41598-020-67936-0.
PubMed 32616939First, M. B., Williams, J. B., Karg, R. S., & Spitzer, R. L. (2016). User's guide for the SCID-5-CV Structured Clinical Interview for DSM-5® disorders: Clinical version. American Psychiatric Publishing, Inc..
Craske MG, Kircanski K, Epstein A, Wittchen HU, Pine DS, Lewis-Fernandez R, Hinton D; DSM V Anxiety; OC Spectrum; Posttraumatic and Dissociative Disorder Work Group. Panic disorder: a review of DSM-IV panic disorder and proposals for DSM-V. Depress Anxiety. 2010 Feb;27(2):93-112. doi: 10.1002/da.20654.
PubMed 20099270
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Imagery Rescripting With and Without Reconsolidation Disruption
- ClinicalTrials.gov ID
- NCT06537284
- Acronym / sponsor ID
- SONATA_BIS_JM2019
- Conditions
- Fear of Failure
- Keywords
- Fear of failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jaroslaw MichalowskiUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Aug 2024 (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 clinical trial compares the effects of Imagery Rescripting intervention with and without memory reconsolidation disruption procedure (ImRs-DSR and ImRs accordingly), to provide evidence for the superiority of the ImRs-DSR. Tested effects include a decrease in psychophysiological (Skin Conductance Level, Salivary alpha amylase) and subjective (questionnaires \& rating) measures in response to imagery scenarios of criticism after 2 weeks of intervention, at 3 \& 6-month follow-ups; also, procedures from basic behavior studies (spontaneous recovery, renewal, reinstatement) will be tested; also, generalizability for the imagery of past criticism scenario that wasn't undergoing intervention \& novel scenario of future criticism (which would be presented at post-treatment, but not at pre-treatment session) will be tested. The scientific team will recruit a subclinical sample of 48 subjects per group (aiming for the recruitment of 67 subjects due to the high drop-out ratio).
Detailed description
The primary objective of this randomized controlled trial is to compare the Imagery Rescripting intervention with and without memory reconsolidation disruption procedure (ImRs-DSR and ImRs accordingly), to provide evidence for the superiority of the ImRs-DSR on a subclinical sample of at least 96 participants (planned recruitment involves 134 participants to accommodate for drop-outs). Investigators plan to test intervention efficacy by measuring response to imagery scenarios of criticism based on interviews with therapists, conducted before the start of the experiment.
The study uses a 2 x 8 mixed factorial design with two interventions (Imagery Rescripting with and without memory reconsolidation disruption), and 8 time points (pre-treatment (time point 1, TP1), 4 intervention sessions (TP2-TP5), post-treatment after 2 weeks of intervention (TP6), 3- and 6-month follow up (TP7, TP8)). The primary intervention lasts 2 weeks and involves 4 intervention sessions.
In terms of hypotheses, investigators expect that the two-week treatment will result in a stable reduction in subjective and physiological measures of emotional distress related to criticism/failure and ImRs-DSR will be more effective than ImRs in achieving this stability. Herewith, investigators expect that psychophysiological response (sAA and SCL) to the imagery of an autobiographical scenario of being criticized that is used for treatment would drop after treatment when investigated in a familiar context in both groups (H1), and the change will be more pronounced in the superior, i.e. ImRs-DSR group (H2). Investigators hypothesize that after treatment, subjective ratings of negative emotional experience during the treated criticism scenario would also be smaller than before in both groups (H3), however, the decrease will be higher in ImRs-DSR (H4). Investigators also hypothesize that similar effects as those defined in H1 and H3 will be also observed after the presentation of the most aversive part of the scenario (hotspot) i.e. at reinstatement (H5) and that they will be more pronounced in ImRs-DSR (vs ImRs) group (H6). According to our assumptions investigators expect that changes achieved after rescripting one criticism-related scenario in a specific context will generalize to other scenarios (i.e. imagining of untreated past criticism or future criticism scenarios, see Imagery stimuli \& interventions section) (H7) and other contexts such as imaging the treated scenario in an unknown room (i.e. renewal) (H8) or various situations verified by PFAI (H9), however, this generalizability will be higher in the ImRs-DSR group with regard to other scenarios (H10), renewal (H11) and PFAI scores (H12). Investigators expect that the changes in reaction (presented in H1, H3, H5, H7, H8, and H9) will be observed after 3 and 6 months (H13), however, a higher decrease will be observed in the ImRs-DSR group (H14).
Primary and secondary outcomes are assessed for criticism-related scenarios using psychophysiology (Skin Conductance Level at pre-, during, and post-treatment, as well as during 3- and 6-month follow-up; Salivary Alpha-Amylase at pre- and post-treatment) and subjective data (online questionnaires and rating, at screening, pre-, during, post-treatment, as well as during 3- and 6-month follow up). Investigators plan to use spontaneous recovery, renewal, and reinstatement procedures to test the efficacy (stability and generalizability) of the studied interventions. For generalizability investigators also plan to test reactions to various imagery scenarios of criticism (un-treated criticism, future criticism). Investigators plan to use 3- and 6-month follow-ups to test long-term effects. Investigators plan to conduct analyses using 2 (arms) x 2 (time points) ANOVA models to check the intervention effects (TP1-TP6 short-term, TP1-TP7/TP8 long-term) on various procedures (spontaneous recovery, renewal, reinstatement). Additional analyses utilize standard NHST calculations and procedures (such as t-tests and correlation coefficients) alongside the conventional ⍺=.05 level.
Investigators plan to use the double-blind procedure, as neither therapists/experimenters will be informed about the arm (arms will be coded in the scripts), nor participants will be informed about conditions in the study, and the research hypotheses will be masked.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR) | Experimental | Behavioral: ImRs-DSRBefore treatment each participant took part in two imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall three events of being criticized for failures (2 past and 1 future events). The treatment scenario involved memory anticipation (similarly framed for all scenarios) that required recalling three images one after another: the image of self, the surroundings, and the person of the critic involved in the scene. After 10 minute break (reconsolidation disruption window) the imagery of the critic was followed by the rescripting part, in which: 1) the therapist enters the scene and prevents the criticism 2) the therapist addresses a critic and points out the child's needs 3) the therapist addresses the child and acknowledges its needs 4) the therapist suggests to the child to perform an activity that would meet its needs. |
| Imagery Rescripting regular (ImRs) | Active comparator | Behavioral: ImRsBefore treatment each participant took part in two imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall three events of being criticized for failures (2 past and 1 future events). The treatment scenario involved memory anticipation (similarly framed for all scenarios) that required recalling three images one after another: the image of self, the surroundings, and the person of the critic involved in the scene. Immediately after the imagery of the critic the rescripting part was presented, in which: 1) the therapist enters the scene and prevents the criticism 2) the therapist addresses a critic and points out the child's needs 3) the therapist addresses the child and acknowledges its needs 4) the therapist suggests to the child to perform an activity that would meet its needs. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adults aged 18-35
- high fear of failure
- not currently undergoing psychotherapy or psychopharmacotherapy
- no severe punitive experiences in the past
Key exclusion criteria (6 listed)
- current severe affective disorders
- current severe anxiety
- current severe personality disorders
- active suicidality
- psychosis
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 |
|---|---|---|
| ImRs-DSRImagery Rescripting with Memory Reconsolidation Disruption | Behavioural | Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR) |
| ImRsImagery Rescripting regular | Behavioural | Imagery Rescripting regular (ImRs) |
Primary outcome
The Performance Failure Appraisal Inventory
Time frame: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
The Performance Failure Appraisal Inventory (PFAI; Conroy, 2001, Polish translation: Golińska, 2017) was used to assess fear of failure. It is a 35-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, with scores ranging 35-175.
Subjective ratings at the end of all sessions
Time frame: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Subjective ratings at the end of all sessions- participants were asked to evaluate each fragment of the presented scenarios according to several measures: immersion, focus, emotions (happiness, sadness, guilt, fear, anger, disgust) on a 9-point Likert scale (very low-very high), and valence (very negative-very positive), scores ranging 1-9 for each factor.
SCL recordings
Time frame: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Skin conductance level (SCL) was collected during the audio-guided scenarios' imagery at pre-treatment, treatment, post-treatment, and follow-up sessions. SCL was acquired using Biopack MP160 EDA-MRI system, with a sampling frequency of 2000Hz. The signal was resampled into 1000Hz, then smoothed with median (100 samples), and filtered with a high-passed 1Hz filter. We calculated normalized change in SCL with equation 100✕(SCLStim-SCLbaseline/SCLbaseline), where SCLStim is the mean signal value during the stimulus and SCLbaseline is an SCL reaction during the baseline preceding the first part in each scenario (Sugimine et al., 2020). Our primary outcome was SCL during the imagery of different scenarios, separated for anticipation and hotspot parts.
Saliva sampling sAA
Time frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6)
Saliva samples were collected on pre- and post-treatment with cotton rolls. Samples were collected using cotton rolls that were chewed for 1 min and were later secured in sterile V-bottom tubes and stored at 4°C temperature upon analysis. Samples were coded and sent to the Institute of Human Genetics Polish Academy of Science where the level of alpha amylase was measured.
10 secondary outcomes
Beck Depression Inventory
Time frame: Screening, 6-month Follow-up
Yale-Brown Obsessive-Compulsive
Time frame: Screening, 6-month Follow-up
The Alcohol Use Disorders Identification Test
Time frame: Screening, 6-month Follow-up
Drug Abuse Screen Test
Time frame: Screening, 6-month Follow-up
DSM Scales
Time frame: Screening, 6-month Follow-up
Structured Clinical Interview for DSM-5 (SCID-5-PD)
Time frame: Screening
M.I.N.I. Mini International Neuropsychiatric Interview
Time frame: Screening
Liebowitz Social Anxiety Scale
Time frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Pure Procrastination Scale
Time frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Frost Multidimensional Perfectionism Scale
Time frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 22997340Agren T, Engman J, Frick A, Bjorkstrand J, Larsson EM, Furmark T, Fredrikson M. Disruption of reconsolidation erases a fear memory trace in the human amygdala. Science. 2012 Sep 21;337(6101):1550-2. doi: 10.1126/science.1223006.
- Background: PubMed 10452174Arntz A, Weertman A. Treatment of childhood memories: theory and practice. Behav Res Ther. 1999 Aug;37(8):715-40. doi: 10.1016/s0005-7967(98)00173-9.
- BackgroundConroy, D. E., Willow, J. P., & Metzler, J. N. (2002). Multidimensional fear of failure measurement: The performance failure appraisal inventory. Journal of applied sport psychology, 14(2), 76-90.
- Background: PubMed 27855298Morina N, Lancee J, Arntz A. Imagery rescripting as a clinical intervention for aversive memories: A meta-analysis. J Behav Ther Exp Psychiatry. 2017 Jun;55:6-15. doi: 10.1016/j.jbtep.2016.11.003. Epub 2016 Nov 9.
- Background: PubMed 24277809Schiller D, Kanen JW, LeDoux JE, Monfils MH, Phelps EA. Extinction during reconsolidation of threat memory diminishes prefrontal cortex involvement. Proc Natl Acad Sci U S A. 2013 Dec 10;110(50):20040-5. doi: 10.1073/pnas.1320322110. Epub 2013 Nov 25.
- Background: PubMed 32569854Siegesleitner M, Strohm M, Wittekind CE, Ehring T, Kunze AE. Improving imagery rescripting treatments: Comparing an active versus passive approach. J Behav Ther Exp Psychiatry. 2020 Dec;69:101578. doi: 10.1016/j.jbtep.2020.101578. Epub 2020 Jun 9.
- Background: PubMed 22298942Wild J, Clark DM. Imagery Rescripting of Early Traumatic Memories in Social Phobia. Cogn Behav Pract. 2011 Nov;18(4):433-443. doi: 10.1016/j.cbpra.2011.03.002.
- Background: PubMed 32616939Sugimine S, Saito S, Takazawa T. Normalized skin conductance level could differentiate physical pain stimuli from other sympathetic stimuli. Sci Rep. 2020 Jul 2;10(1):10950. doi: 10.1038/s41598-020-67936-0.
- BackgroundFirst, M. B., Williams, J. B., Karg, R. S., & Spitzer, R. L. (2016). User's guide for the SCID-5-CV Structured Clinical Interview for DSM-5® disorders: Clinical version. American Psychiatric Publishing, Inc..
- Background: PubMed 20099270Craske MG, Kircanski K, Epstein A, Wittchen HU, Pine DS, Lewis-Fernandez R, Hinton D; DSM V Anxiety; OC Spectrum; Posttraumatic and Dissociative Disorder Work Group. Panic disorder: a review of DSM-IV panic disorder and proposals for DSM-V. Depress Anxiety. 2010 Feb;27(2):93-112. doi: 10.1002/da.20654.
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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. This study is not recruiting at the moment.
Jarosław Michałowski, PHD 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 ImRs-DSR and ImRs in people with Fear of Failure, run by Jaroslaw Michalowski 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 5 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Performance Failure Appraisal Inventory (time frame: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)). The study lists 4 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 NCT06537284, which also lists 10 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 5 Aug 2024.