Clinical trial NCT06372405: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia
Official title: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Misophonia Treatment
Keywords: misophonia
sound over-responsivity
cognitive reappraisal
relaxation training
CBT
psychotherapy
psychophysiology
Lead sponsor: University of Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2024-04-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (M.I.N.I.) 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in misophonia symptoms measured by S-Five - Externalizing subscale
timeFrame: 1st assessment - 3-10 days before the 1st therapy session. 2nd assessment: 3-10 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change in misophonia symptoms measured by S-Five - Internalizing subscale
timeFrame: 1st assessment - 3-10 days before the 1st therapy session. 2nd assessment: 3-10 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change in misophonia symptoms measured by S-Five - Threat subscale
timeFrame: 1st assessment - 3-10 days before the 1st therapy session. 2nd assessment: 3-10 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change in misophonia symptoms measured by S-Five - Impact subscale
timeFrame: 1st assessment - 3-10 days before the 1st therapy session. 2nd assessment: 3-10 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: CHange in misophonia symptoms measured by S-Five - Outburst subscale
timeFrame: 1st assessment - 3-10 days before the 1st therapy session. 2nd assessment: 3-10 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change of aversiveness rating (valence/pleasure) on the Manikin Scales.
timeFrame: 1st assessment - 3-8 days before the 1st therapy session. 2nd assessment: 3-8 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change of arousal rating on the Manikin Scales.
timeFrame: 1st assessment - 3-8 days before the 1st therapy session. 2nd assessment: 3-8 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change in Galvanic Skin Response
timeFrame: 1st assessment - 3-8 days before the 1st therapy session. 2nd assessment: 3-8 days after the last (the 4th) therapy session. (There are 4 weekly sessions throughout one month).
measure: Change in average HR during the trigger presentation
timeFrame: Baseline vs. post-treatment assessment (which will be performed 5 to 12 weeks since the last session).
measure: Diagnosis of personality disorders as a predictor of worse treatment outcome.
timeFrame: 3 to 10 days before the 1st session
measure: Working Alliance Inventory will be related to better treatment outcomes.
timeFrame: 3-8 days after the last (the 4th) therapy session (There are 4 weekly sessions throughout one month)
Secondary outcomes:
measure: Meeting criteria for psychiatric disorders -
timeFrame: 3 to 10 days before the 1st session
measure: Hearing test - standard and high frequency pure-tone audiometry
timeFrame: 3 to 10 days after the 4st session
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Faculty of Psychology, University of Warsaw
state: Masovian Voivodeship
Study officials:
References: