Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537284
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Comparison of Imagery Rescripting With and Without Reconsolidation Disruption
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of Imagery Rescripting With and Without Reconsolidation Disruption
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 wasnt 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 criticismfailure 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 ie 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 ie 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 ie 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 ie 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-TP7TP8 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 therapistsexperimenters 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
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 criticismfailure 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 ie 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 ie 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 ie 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 ie 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-TP7TP8 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 therapistsexperimenters 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None