Comparison of Imagery Rescripting With and Without Reconsolidation Disruption
- Conditions
- Fear of Failure
- Registration Number
- NCT06537284
- Lead Sponsor
- Jaroslaw Michalowski
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- adults aged 18-35
- high fear of failure
- not currently undergoing psychotherapy or psychopharmacotherapy
- no severe punitive experiences in the past
- current severe affective disorders
- current severe anxiety
- current severe personality disorders
- active suicidality
- psychosis
- substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method The Performance Failure Appraisal Inventory 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.
Saliva sampling sAA 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.
Subjective ratings at the end of all sessions 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 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.
- Secondary Outcome Measures
Name Time Method Drug Abuse Screen Test Screening, 6-month Follow-up 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.
DSM Scales Screening, 6-month Follow-up 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.
Structured Clinical Interview for DSM-5 (SCID-5-PD) Screening 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.
Liebowitz Social Anxiety Scale Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8) 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.
Pure Procrastination Scale Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8) 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.
Frost Multidimensional Perfectionism Scale Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8) 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.
Beck Depression Inventory Screening, 6-month Follow-up 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.
Yale-Brown Obsessive-Compulsive Screening, 6-month Follow-up 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.
The Alcohol Use Disorders Identification Test Screening, 6-month Follow-up 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.
M.I.N.I. Mini International Neuropsychiatric Interview Screening 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.
Trial Locations
- Locations (1)
SWPS University
🇵🇱Warsaw, Mazowsze, Poland
SWPS University🇵🇱Warsaw, Mazowsze, Poland