Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia

NCT ID: NCT06372405

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-09-30

Brief Summary

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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 (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD)

Detailed Description

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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 emotions/arousal (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.

Conditions

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Misophonia Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Reappraisal

Cognitive reappraisal is a psychotherapeutic strategy utilized to regulate emotions by reinterpreting the meaning of stimuli. Participants will receive instructions on generating and implementing cognitive reappraisal in both misophonic and non-misophonic contexts and will be practicing it within psychotherapeutic sessions. The program consists of four weekly online psychotherapeutic sessions: the first session will be a 90-minute group session, followed by three individual sessions, each lasting 30 minutes.

Group Type EXPERIMENTAL

Cognitive reappraisal

Intervention Type BEHAVIORAL

Cognitive reappraisal is a psychotherapeutic strategy utilized to regulate emotions by reinterpreting the meaning of stimuli. Participants will receive instructions on generating and implementing cognitive reappraisal (distancing and reframing) in both misophonic and non-misophonic contexts and will be practicing it within psychotherapeutic sessions. The program consists of four weekly online psychotherapeutic sessions: the first session will be a 90-minute group session, followed by three individual sessions, each lasting 30 minutes.

Schultz Autogenic Training

Schultz Autogenic Training is a relaxation technique aimed at promoting relaxation and reducing physiological arousal. It consists of six exercises focusing on sensations of heaviness, warmth, heartbeat, breathing, abdominal warmth, and coolness of the forehead.

Group Type ACTIVE_COMPARATOR

Schultz Autogenic Training

Intervention Type BEHAVIORAL

Schultz Autogenic Training is a relaxation technique aimed at promoting relaxation and reducing physiological arousal. It consists of six exercises focusing on sensations of heaviness, warmth, heartbeat, breathing, abdominal warmth, and coolness of the forehead. The program consists of four weekly online psychotherapeutic sessions: the first session will be a 90-minute group session, followed by three individual sessions, each lasting 30 minutes.

Interventions

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Cognitive reappraisal

Cognitive reappraisal is a psychotherapeutic strategy utilized to regulate emotions by reinterpreting the meaning of stimuli. Participants will receive instructions on generating and implementing cognitive reappraisal (distancing and reframing) in both misophonic and non-misophonic contexts and will be practicing it within psychotherapeutic sessions. The program consists of four weekly online psychotherapeutic sessions: the first session will be a 90-minute group session, followed by three individual sessions, each lasting 30 minutes.

Intervention Type BEHAVIORAL

Schultz Autogenic Training

Schultz Autogenic Training is a relaxation technique aimed at promoting relaxation and reducing physiological arousal. It consists of six exercises focusing on sensations of heaviness, warmth, heartbeat, breathing, abdominal warmth, and coolness of the forehead. The program consists of four weekly online psychotherapeutic sessions: the first session will be a 90-minute group session, followed by three individual sessions, each lasting 30 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identification of experiencing stress due to eating sounds, confirmed during a subsequent online face-to-face diagnostic meeting,
* Confirmation of misophonia symptoms through a face-to-face/online interview using the Duke Misophonia Interview (DMI; Polish adaptation),
* being fluent in the Polish language,
* age range: 18-55,
* not having been in therapy within the last 3 months.

Exclusion Criteria

* Individuals identified with misophonia (indicated by DMI) who do not experience triggers related to eating sounds,
* At the time of recruitment: individuals meeting criteria for current mania, anorexia, psychotic episode/disorder, significant or sudden crisis, or reporting current suicidal ideations,
* Individuals with heart diseases or pacemakers, or those taking cardiac medications,
* Individuals reporting a diagnosis of hearing loss or significant hearing difficulties.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

University of Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Psychology, University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marta Siepsiak, phd

Role: CONTACT

0048661152533

Facility Contacts

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Marta Siepsiak, PhD

Role: primary

0048661152533

Other Identifiers

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PSP-501/D125/79/00000

Identifier Type: -

Identifier Source: org_study_id

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