Clinical trial NCT06537284: Comparison of Imagery Rescripting With and Without Reconsolidation Disruption
Official title: Randomized Controlled Trial of Imagery Rescripting With and Without Reconsolidation Disruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Failure
Keywords: Fear of failure
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2024-08-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Performance Failure Appraisal Inventory
timeFrame: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
measure: Subjective ratings at the end of all sessions
timeFrame: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
measure: SCL recordings
timeFrame: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
measure: Saliva sampling sAA
timeFrame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6)
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Screening, 6-month Follow-up
measure: Yale-Brown Obsessive-Compulsive
timeFrame: Screening, 6-month Follow-up
measure: The Alcohol Use Disorders Identification Test
timeFrame: Screening, 6-month Follow-up
measure: Drug Abuse Screen Test
timeFrame: Screening, 6-month Follow-up
measure: DSM Scales
timeFrame: Screening, 6-month Follow-up
measure: Structured Clinical Interview for DSM-5 (SCID-5-PD)
timeFrame: Screening
measure: M.I.N.I. Mini International Neuropsychiatric Interview
timeFrame: Screening
measure: Liebowitz Social Anxiety Scale
timeFrame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
measure: Pure Procrastination Scale
timeFrame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
measure: Frost Multidimensional Perfectionism Scale
timeFrame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: SWPS University
state: Mazowsze
Study officials:
affiliation: SWPS University
name: Jarosław Michałowski, PHD
role: PRINCIPAL_INVESTIGATOR
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