- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07048756
- Original Trial
Psychotherapeutic Imagery Techniques (JM2019a)
Enhancing the Efficacy of Psychotherapeutic Imagery Techniques: A Randomized Controlled Trial
This randomized controlled trial (RCT) examines the efficacy of Imagery Exposure (IE), Imagery Rescripting (ImRs), and Compassion-Focused Therapy (CFT) in individuals with a high fear of failure. Participants (N=220) were randomly assigned to IE, ImRs, ImRs with a 10-minute break (ImRs-DSR), or CFT-based Imagery Rescripting (CFT_ImRs). Due to funding constraints, the CFT_ImRs group included a reduced sample (N=40, targeting 30 completers).
The two-week intervention consists of four structured imagery sessions. IE involves exposure to criticism-related memories without modification. In the ImRs group memory reactivation to criticism-related memories is followed by positive reappraisal. ImRs-DSR introduces a 10-minute delay before reappraisal to enhance memory updating. CFT_ImRs incorporates Compassion-Focused Therapy (CFT) principles into reappraisal, emphasizing self-compassion.
Primary outcomes include skin conductance level (SCL) and subjective emotional responses to criticism-related (and control) memories, changes in fear of failure and dysfunctional beliefs. All these variables are assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups. Results will be analyzed separately for:
IE vs. ImRs (rescripting vs. exposure and physiological predictors), ImRs vs. ImRs-DSR (memory reconsolidation effects), IE vs. CFT_ImRs (CFT vs. exposure efficacy).
Study Overview
Status
Conditions
Detailed Description
This study aims to investigate the efficacy and underlying psychological mechanisms of Imagery Rescripting (ImRs), Imagery Exposure (IE), and Compassion-Focused Therapy (CFT) in individuals with high fear of failure. The project is designed as a randomized controlled trial (RCT) comparing four intervention conditions: Imagery Exposure (IE), standard Imagery Rescripting (ImRs), Imagery Rescripting with a 10-minute break (ImRs-DSR), and CFT-based Imagery Rescripting (CFT_ImRs). The addition of the CFT_ImRs condition was based on the decision to explore whether compassion-focused elements provide additional benefits in reducing criticism-related subjective and autonomic responses.
The study enrolled 220 participants, randomly assigned to one of the four groups (IE, ImRs, ImRs-DSR, CFT_ImRs) in a 3:3:3:2 allocation ratio. Due to funding limitations for CFT_ImRs, recruitment for this group has been capped at 40 participants, with the goal of obtaining a final sample of 30 subjects for the study phase. The treatment phase takes two weeks starting just after pre-treatment assessments and consisting of four treatment sessions. Each of them involves exposure to autobiographical memories of childhood criticism, presented in an audio format. The IE condition involves prolonged exposure to the criticism scene without modifications. In the ImRs condition, the reactivation of memory is followed by a positive reappraisal, where an imagined caregiver acknowledges the participant's needs. In ImRs-DSR, a 10-minute break separates the memory reactivation from the positive reappraisal, aiming to enhance memory updating by increasing memory trace destabilization. In the CFT_ImRs condition, the part aiming at positive reappraisal differs from the one used in ImRs condition by incorporating some principles of Compassion-Focused Imagery Rescripting.
Primary outcome measures include physiological arousal (skin conductance level, SCL), subjective ratings, and changes in self-reported fear of failure and dysfunctional beliefs. Treatment effects will be evaluated at pre-treatment, post-treatment, and at 3- and 6-month follow-ups. The efficacy and stability of each intervention will be assessed using renewal, reacquisition, and reinstatement paradigms, as they are known from behavioral studies.
Due to the broad scope of this study, the results will be reported separately for different comparisons, as each addresses distinct research questions:
IE vs. ImRs: Examines whether rescripting differs from exposure and how the dynamics of physiological arousal influences treatment outcomes.
ImRs vs. ImRs-DSR: Investigates whether adding a mechanism for interrupting memory reconsolidation improves the efficacy of ImRs.
IE vs. CFT_ImRs: Evaluates the efficacy of Compassion-Focused Therapy in comparison to exposure-based treatment.
This study seeks to determine whether standard ImRs is better than IE and whether ImRs-DSR or CFT_ImRs provide additional benefits in reducing criticism-related subjective and autonomic responses, and whether the dynamics of physiological arousal during imagery predicts treatment responses. The findings may contribute to optimizing imagery-based therapeutic techniques for individuals with pathological fear of failure.
Due to human error in study planning, the retrospective registration for the ImRs vs. ImRs-DSR condition has already been registered in another repository under the following code: NCT06537284.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wielkopolska
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Poznań, Wielkopolska, Poland, 61-719
- Poznań Laboratory of Affective Neuroscience, Institute of Psychology, SWPS University, Warsaw, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Imagery Rescripting (ImRs)
Before treatment each participant took part in 2 imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall 3 events of being criticized for failures (2 past and 1 future events).
Information from these sessions was used to create 1 criticism scenario related to the future and 2 related to the past, one of the latter was processed into a treatment scenario.
Each of the 3 scenarios consisted of a memory anticipation part that required recalling 3 images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
In the treatment scenario immediately after the imagery of the critic the rescripting part was presented, in which: 1. therapist enters the scene and prevents the criticism 2. therapist addresses a critic and points out the child's needs 3. therapist addresses the child and acknowledges its needs 4. therapist suggests to the child to perform an activity that would meet its needs.
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Imagery Rescripting (Regular)
Other Names:
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Experimental: Imagery Rescripting with memory reconsolidation disruption (ImRs-DSR)
Before treatment each participant took part in 2 imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall 3 events of being criticized for failures (2 past and 1 future events).
Information from these sessions was used to create 1 criticism scenario related to the future and 2 related to the past, one of the latter was processed into a treatment scenario.
Each of the 3 scenarios consisted of a memory anticipation part that required recalling 3 images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
In the treatment scenario 10 minutes 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.
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Imagery Rescripting with Disruption of Reconsolidation
Other Names:
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Experimental: Imagery Exposure (IE)
Before treatment each participant took part in 2 imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall 3 event of being criticized for failures.
Information from these sessions was used to create 1 criticism scenario related to the future and 2 related to the past, one of the latter was processed into a treatment scenario.
Each of the 3 scenarios consisted of a memory anticipation part that required recalling 3 images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
In the treatment scenario the imagery of the critic was followed by the prolonged exposure to the criticism situation.
|
Imagery Exposure
Other Names:
|
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Experimental: Compassion-Focused Therapy Imagery Rescripting (CFT_ImRs)
Before treatment each participant took part in 2 imagery sessions during which a cognitive-behavioral therapist (CBT) asked him/her to recall 3 event of being criticized for failures.
Information from these sessions was used to create 1 criticism scenario related to the future and 2 related to the past, one of the latter was processed into a treatment scenario.
Each of the 3 scenarios consisted of a memory anticipation part that required recalling 3 images one after another: the image of self, the surroundings, and the person of the critic involved in the scene.
In the treatment scenario immediately after the imagery of the critic the rescripting part was presented, in which: 1) therapist expressed intention to protect the child 2) desire to reduce the child's suffering 3) explained that suffering is part of the human experience 4) provided sense of community and understanding.
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Imagery Rescripting in Compassion-Focused Therapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SCL recordings
Time Frame: Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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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.
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Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Saliva sampling sAA
Time Frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6)
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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.
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Pre-Treatment (TP1), 2-weeks post-treatment (TP6)
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Subjective ratings at the end of all sessions
Time Frame: 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.
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Pre-Treatment (TP1), during 2-weeks treatment (TP2-TP5), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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The Performance Failure Appraisal Inventory
Time Frame: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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The Performance Failure Appraisal Inventory 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.
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Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory
Time Frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
|
Beck Depression Inventory second edition (BDI-II) is a self-report scale using 21 items regarding the presence and strength of depression symptoms, with scores ranging 0-63.
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Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Yale-Brown Obsessive-Compulsive
Time Frame: Screening, 6-month Follow-up (TP8)
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Yale-Brown Obsessive-Compulsive self-report severity scale Y-BOCS-SR a 10-item, self-report questionnaire created to evaluate OCD severity, scores ranging 0-40.
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Screening, 6-month Follow-up (TP8)
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The Alcohol Use Disorders Identification Test
Time Frame: Screening, 6-month Follow-up (TP8)
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The Alcohol Use Disorders Identification Test AUDIT 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.
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Screening, 6-month Follow-up (TP8)
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Drug Abuse Screen Test
Time Frame: Screening, 6-month Follow-up (TP8)
|
Drug Abuse Screen Test DAST 10 is a self-reported questionnaire to detect drug use disorders, scores ranging 0-10.
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Screening, 6-month Follow-up (TP8)
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Structured Clinical Interview for DSM-5 (SCID-5-PD)
Time Frame: Screening
|
Structured Clinical Interview for DSM-5 SCID-5-PD 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.
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Screening
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M.I.N.I. Mini International Neuropsychiatric Interview
Time Frame: Screening
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M.I.N.I.
Mini International Neuropsychiatric Interview 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.
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Screening
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Liebowitz Social Anxiety Scale
Time Frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Liebowitz Social Anxiety Scale (LSAS) 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.
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Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Pure Procrastination Scale
Time Frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Pure Procrastination Scale (PPS) 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.
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Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Frost Multidimensional Perfectionism Scale
Time Frame: Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
|
Frost Multidimensional Perfectionism Scale 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.
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Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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Social Anxiety Disorder Scale (DSM)
Time Frame: Screening, 6-month Follow-up (TP8)
|
Self-report dimensional scale for Social Anxiety Disorder based on DSM-5 criteria.
The scale consists of 10 items measuring frequency of symptoms experienced in the last 7 days.
Each item is rated on a 4-point Likert scale (0 = never, 4 = all the time).
Scores range 0-40, with higher scores indicating greater symptom severity.
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Screening, 6-month Follow-up (TP8)
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Agoraphobia Scale (DSM)
Time Frame: Screening, 6-month Follow-up (TP8)
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Self-report dimensional scale for Agoraphobia based on DSM-5 criteria.
The scale includes 10 items evaluating thoughts, feelings, and behaviors associated with agoraphobic avoidance in the past 7 days.
Each item is scored on a 0-4 scale.
Total score range: 0-40.
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Screening, 6-month Follow-up (TP8)
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Panic Disorder Scale (DSM)
Time Frame: Screening, 6-month Follow-up (TP8)
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10-item self-rating questionnaire based on DSM-5 criteria for Panic Disorder.
The scale assesses symptom frequency over the past 7 days using a 4-point Likert scale (0-4), with total scores ranging from 0 to 40.
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Screening, 6-month Follow-up (TP8)
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Generalized Anxiety Disorder Scale (DSM)
Time Frame: Screening, 6-month Follow-up (TP8)
|
A dimensional measure for Generalized Anxiety Disorder based on DSM-5, comprising 10 items.
Participants indicate how frequently they experienced each symptom during the past 7 days.
Scoring is on a 4-point Likert scale from 0 (never) to 4 (all the time), with total scores ranging 0-40.
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Screening, 6-month Follow-up (TP8)
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Post-Traumatic Stress Symptoms Scale (DSM)
Time Frame: Screening, 6-month Follow-up (TP8)
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Self-report scale assessing PTSD symptoms as defined by DSM-5 criteria.
The instrument includes 10 items evaluating symptom frequency over the previous 7 days on a 0-4 Likert scale.
Total scores range from 0 to 40.
|
Screening, 6-month Follow-up (TP8)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jarosław M. Michałowski, PhD, SWPS University
Publications and helpful links
General Publications
- Arntz A, Weertman A. Treatment of childhood memories: theory and practice. Behav Res Ther. 1999 Aug;37(8):715-40. doi: 10.1016/s0005-7967(98)00173-9.
- Agren T, Engman J, Frick A, Bjorkstrand J, Larsson EM, Furmark T, Fredrikson M. Disruption of reconsolidation erases a fear memory trace in the human amygdala. Science. 2012 Sep 21;337(6101):1550-2. doi: 10.1126/science.1223006.
- Conroy, D. E., Willow, J. P., & Metzler, J. N. (2002). Multidimensional fear of failure measurement: The performance failure appraisal inventory. Journal of applied sport psychology, 14(2), 76-90.
- Morina N, Lancee J, Arntz A. Imagery rescripting as a clinical intervention for aversive memories: A meta-analysis. J Behav Ther Exp Psychiatry. 2017 Jun;55:6-15. doi: 10.1016/j.jbtep.2016.11.003. Epub 2016 Nov 9.
- Schiller D, Kanen JW, LeDoux JE, Monfils MH, Phelps EA. Extinction during reconsolidation of threat memory diminishes prefrontal cortex involvement. Proc Natl Acad Sci U S A. 2013 Dec 10;110(50):20040-5. doi: 10.1073/pnas.1320322110. Epub 2013 Nov 25.
- Siegesleitner M, Strohm M, Wittekind CE, Ehring T, Kunze AE. Improving imagery rescripting treatments: Comparing an active versus passive approach. J Behav Ther Exp Psychiatry. 2020 Dec;69:101578. doi: 10.1016/j.jbtep.2020.101578. Epub 2020 Jun 9.
- Wild J, Clark DM. Imagery Rescripting of Early Traumatic Memories in Social Phobia. Cogn Behav Pract. 2011 Nov;18(4):433-443. doi: 10.1016/j.cbpra.2011.03.002.
- Sugimine S, Saito S, Takazawa T. Normalized skin conductance level could differentiate physical pain stimuli from other sympathetic stimuli. Sci Rep. 2020 Jul 2;10(1):10950. doi: 10.1038/s41598-020-67936-0.
- Craske MG, Kircanski K, Epstein A, Wittchen HU, Pine DS, Lewis-Fernandez R, Hinton D; DSM V Anxiety; OC Spectrum; Posttraumatic and Dissociative Disorder Work Group. Panic disorder: a review of DSM-IV panic disorder and proposals for DSM-V. Depress Anxiety. 2010 Feb;27(2):93-112. doi: 10.1002/da.20654.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SONATA_BIS_JM2019a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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