Comparison of Imagery Rescripting With and Without Reconsolidation Disruption

NCT06537284 | Completed

• 1 other identifier: SONATA_BIS_JM2019
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Fear of Failure

Keywords

Fear of failure

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Pre-Treatment (TP1), 2-weeks post-treatment (TP6)

Secondary Outcomes (10)

• Beck Depression Inventory

  Screening, 6-month Follow-up

• Yale-Brown Obsessive-Compulsive

  Screening, 6-month Follow-up

• The Alcohol Use Disorders Identification Test

  Screening, 6-month Follow-up

• Drug Abuse Screen Test

  Screening, 6-month Follow-up

• DSM Scales

  Screening, 6-month Follow-up

Study Arms (2)

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.

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.

Behavioral: ImRs

Interventions

ImRs-DSR BEHAVIORAL

Imagery Rescripting with Memory Reconsolidation Disruption

Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR)

ImRs BEHAVIORAL

Imagery Rescripting regular

Imagery Rescripting regular (ImRs)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults aged 18-35
• high fear of failure
• not currently undergoing psychotherapy or psychopharmacotherapy
• no severe punitive experiences in the past

You may not qualify if:

• current severe affective disorders
• current severe anxiety
• current severe personality disorders
• active suicidality
• psychosis
• substance abuse

Sponsors & Collaborators

• Jaroslaw Michalowski: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

SWPS University

Warsaw, Mazowsze, 03-815, Poland

Location

Related Publications (10)

• 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.

  PMID: 22997340 BACKGROUND

• Arntz 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.

  PMID: 10452174 BACKGROUND

• Conroy, 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

• 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.

  PMID: 27855298 BACKGROUND

• Schiller 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.

  PMID: 24277809 BACKGROUND

• Siegesleitner 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.

  PMID: 32569854 BACKGROUND

• Wild 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.

  PMID: 22298942 BACKGROUND

• Sugimine 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.

  PMID: 32616939 BACKGROUND

• First, 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

• 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.

  PMID: 20099270 BACKGROUND

Study Officials

• Jarosław Michałowski, PHD

  SWPS University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Investigators plan to use the double-blind procedure, as neither therapists will be informed about the arm (arms will be coded in the scripts), nor participants will be informed about conditions in the study, the research hypotheses will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 5, 2024
• Study Start: June 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

PL (1)