Comparison of Imagery Rescripting With and Without Reconsolidation Disruption
NCT Number: NCT06537284
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fear of Failure
Interventions: BEHAVIORAL: ImRs-DSR|BEHAVIORAL: ImRs
Sponsor: Jaroslaw Michalowski
Collaborators: National Science Centre, Poland
Sex: ALL
Age: ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-06-01
Completion Date: 2022-12-31
Locations: SWPS University, Warsaw, Mazowsze, 03-815, Poland

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).

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)