Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372405
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-25
Brief Title:
Instructed Cognitive Reappraisal in Reducing Affective Behavioral and Psychophysiological Symptoms of Misophonia
Sponsor:
University of Warsaw Poland
Organization:
University of Warsaw Poland
Study Overview
Official Title:
Instructed Cognitive Reappraisal in Reducing Affective Behavioral and Psychophysiological Symptoms of Misophonia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Misophonia is a disorder causing intense reactions to specific sounds disrupting daily life Current treatments lack evidence-based support The goal of this study is to explore the effectiveness of cognitive reappraisal CR in reducing misophonic responses The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training Emotional regulation symptoms of anxiety and depression quality of life and more will be assessed using various questionnaire-based measures perseverations with a task-based test Wisconsin Card Sorting Test the presence of psychiatric and personality disorders using face-to-face interviews The Mini-International Neuropsychiatric Interview MINI and Structured Clinical Interview for DSM-5 Personality Disorders SCID-5-PD
Detailed Description:
Misophonia is a condition characterized by a reduced tolerance for certain repetitive stimuli particularly sounds leading to significant disruptions in daily functioning Despite ongoing efforts to understand its mechanisms and develop effective treatments there is currently no established intervention for misophonia While preliminary research suggests cognitive reappraisal CR might help with misophonia symptoms no studies have directly investigated its effectiveness in individuals with misophonia
Our main goal is to assess how effective brief instructed CR and a 4-week CR training program are in regulating emotional responses among individuals with misophonia The following outcomes are anticipated
1 After completing a dedicated 4-week CR program targeting misophonia participants are expected to exhibit improved emotional regulation in response to misophonic triggers This improvement should lead to reduced misophonia symptoms particularly noticeable in experimental tasks involving misophonic triggers and in questionnaire-based assessments especially in the Externalizing and Impact S-Five scales In the active control group AT the investigators predict no change in emotional response Manikin scales in the experimental task responses to misophonic and non-misophonic triggers Additionally the investigators expect no decrease in misophonia symptoms in the Externalizing Scale based on questionnaire assessments However in the control group AT a slight but not significant reduction in overall misophonia anxiety and depression symptoms is anticipated reflected in questionnaire assessments
2 Participants may regulate emotional responses less effectively using CR in response to misophonia-specific aversive stimuli compared to non-misophonia-related aversive stimuli both before and after the misophonia-focused 4-week CR training
3 The misophonia-focused 4-week CR training will significantly enhance the effectiveness of short cognitive reappraisal training
Additionally the investigators aim to explore factors that might affect intervention outcomes such as comorbid disorders perseveration relationship with the therapist during CR training attitudes towards the treatment and more
EXPERIMENTAL ASSESSMENT The experimental assessment in the psychophysiology lab aims to evaluate the ability to use instructed cognitive reappraisal before and after four weeks of training Before the experiment there will be a 10-minute instruction session to teach the participants in CR group this technique During the experiment participants will be presented with a series of misophonic 3 non-misophonic aversive stimuli 3 and neutral stimuli 3 each lasting 30 seconds presented in quasi-randomized balanced orders The aversive misophonia and non-misophonic audio-video stimuli will be presented under two conditions look where participants will be instructed to only look and not use any strategies to regulate their emotions and decrease where they will have to use a cognitive reappraisal CR technique to decrease their unpleasant emotionsarousal or trying to think in a way to decrease the unpleasant emotions in the control group The neutral conditions will also be presented twice each but always with the instruction look After each stimulus presentation participants will be asked to rate their emotions using the Manikin scales for valence and arousal At the end of the trials they will be asked to report the amount of effort on a 10-point scale they had to exert for each of the aversive stimuli Physiological data heart rate HR Skin Conductance Response SCR and facial corrugator by electromyography EMG will be collected
Our main goal is to assess how effective brief instructed CR and a 4-week CR training program are in regulating emotional responses among individuals with misophonia The following outcomes are anticipated
1 After completing a dedicated 4-week CR program targeting misophonia participants are expected to exhibit improved emotional regulation in response to misophonic triggers This improvement should lead to reduced misophonia symptoms particularly noticeable in experimental tasks involving misophonic triggers and in questionnaire-based assessments especially in the Externalizing and Impact S-Five scales In the active control group AT the investigators predict no change in emotional response Manikin scales in the experimental task responses to misophonic and non-misophonic triggers Additionally the investigators expect no decrease in misophonia symptoms in the Externalizing Scale based on questionnaire assessments However in the control group AT a slight but not significant reduction in overall misophonia anxiety and depression symptoms is anticipated reflected in questionnaire assessments
2 Participants may regulate emotional responses less effectively using CR in response to misophonia-specific aversive stimuli compared to non-misophonia-related aversive stimuli both before and after the misophonia-focused 4-week CR training
3 The misophonia-focused 4-week CR training will significantly enhance the effectiveness of short cognitive reappraisal training
Additionally the investigators aim to explore factors that might affect intervention outcomes such as comorbid disorders perseveration relationship with the therapist during CR training attitudes towards the treatment and more
EXPERIMENTAL ASSESSMENT The experimental assessment in the psychophysiology lab aims to evaluate the ability to use instructed cognitive reappraisal before and after four weeks of training Before the experiment there will be a 10-minute instruction session to teach the participants in CR group this technique During the experiment participants will be presented with a series of misophonic 3 non-misophonic aversive stimuli 3 and neutral stimuli 3 each lasting 30 seconds presented in quasi-randomized balanced orders The aversive misophonia and non-misophonic audio-video stimuli will be presented under two conditions look where participants will be instructed to only look and not use any strategies to regulate their emotions and decrease where they will have to use a cognitive reappraisal CR technique to decrease their unpleasant emotionsarousal or trying to think in a way to decrease the unpleasant emotions in the control group The neutral conditions will also be presented twice each but always with the instruction look After each stimulus presentation participants will be asked to rate their emotions using the Manikin scales for valence and arousal At the end of the trials they will be asked to report the amount of effort on a 10-point scale they had to exert for each of the aversive stimuli Physiological data heart rate HR Skin Conductance Response SCR and facial corrugator by electromyography EMG will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None