Comparison of Imagery Rescripting With and Without Reconsolidation Disruption

Jaroslaw Michalowski

Status: Completed

Conditions: Fear of Failure

Treatments: Behavioral: ImRs; Behavioral: ImRs-DSR

Study type: Interventional

Funder types: Other

Identifiers

NCT06537284

SONATA_BIS_JM2019

Details and patient eligibility

About

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).

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR)

Experimental group

Description:

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.

Treatment:

Behavioral: ImRs-DSR

Imagery Rescripting regular (ImRs)

Active Comparator group

Description:

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.

Treatment:

Behavioral: ImRs