Enhancing the Efficacy of Psychotherapeutic Imagery Techniques: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The Performance Failure Appraisal Inventory
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18-35
- •high fear of failure
- •not currently undergoing psychotherapy or psychopharmacotherapy
- •no severe punitive experiences in the past
排除标准
- •current severe affective disorders
- •current severe anxiety
- •current severe personality disorders
- •active suicidality
- •psychosis
- •substance abuse
研究组 & 干预措施
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.
干预措施: Imagery Rescripting (Behavioral)
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.
干预措施: Imagery Rescripting with Disruption of Reconsolidation (Behavioral)
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.
干预措施: Imagery Exposure (Behavioral)
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.
干预措施: Compassion-Focused Therapy Imagery Rescripting (Behavioral)
结局指标
主要结局
The Performance Failure Appraisal Inventory
时间窗: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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.
Subjective ratings at the end of all sessions
时间窗: 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
时间窗: 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.
Saliva sampling sAA
时间窗: 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.
The Performance Failure Appraisal Inventory
时间窗: Screening, 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8)
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.
Subjective ratings at the end of all sessions
时间窗: 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
时间窗: 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.
Saliva sampling sAA
时间窗: 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.
次要结局
- Beck Depression Inventory(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Yale-Brown Obsessive-Compulsive(Screening, 6-month Follow-up (TP8))
- The Alcohol Use Disorders Identification Test(Screening, 6-month Follow-up (TP8))
- Drug Abuse Screen Test(Screening, 6-month Follow-up (TP8))
- Structured Clinical Interview for DSM-5 (SCID-5-PD)(Screening)
- M.I.N.I. Mini International Neuropsychiatric Interview(Screening)
- Liebowitz Social Anxiety Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Pure Procrastination Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Frost Multidimensional Perfectionism Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- The Alcohol Use Disorders Identification Test(Screening, 6-month Follow-up (TP8))
- Drug Abuse Screen Test(Screening, 6-month Follow-up (TP8))
- Beck Depression Inventory(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Yale-Brown Obsessive-Compulsive(Screening, 6-month Follow-up (TP8))
- Structured Clinical Interview for DSM-5 (SCID-5-PD)(Screening)
- M.I.N.I. Mini International Neuropsychiatric Interview(Screening)
- Liebowitz Social Anxiety Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Pure Procrastination Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Frost Multidimensional Perfectionism Scale(Pre-Treatment (TP1), 2-weeks post-treatment (TP6), 3- & 6-month follow-up (TP7, TP8))
- Social Anxiety Disorder Scale (DSM)(Screening, 6-month Follow-up (TP8))
- Agoraphobia Scale (DSM)(Screening, 6-month Follow-up (TP8))
- Panic Disorder Scale (DSM)(Screening, 6-month Follow-up (TP8))
- Generalized Anxiety Disorder Scale (DSM)(Screening, 6-month Follow-up (TP8))
- Post-Traumatic Stress Symptoms Scale (DSM)(Screening, 6-month Follow-up (TP8))
研究者
Jaroslaw Michalowski
Professor
University SWPS