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

NCT06372405 | Recruiting

• 1 other identifier: PSP-501/D125/79/00000
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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)

Conditions

Misophonia Treatment

Keywords

misophonia; sound over-responsivity; cognitive reappraisal; relaxation training; CBT; psychotherapy; psychophysiology

Outcome Measures

Primary Outcomes (11)

• Change in misophonia symptoms measured by S-Five - Externalizing subscale

  S-Five is a validated questionnaire used in Poland to assess misophonia symptoms. Higher values indicate more severe misophonia symptoms, with a range of 0-50 for each subscale.

  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).

• Change in misophonia symptoms measured by S-Five - Internalizing subscale

  S-Five is a validated questionnaire used in Poland to assess misophonia symptoms. Higher values indicate more severe misophonia symptoms, with a range of 0-50 for each subscale.

  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).

• Change in misophonia symptoms measured by S-Five - Threat subscale

  S-Five is a validated questionnaire used in Poland to assess misophonia symptoms. Higher values indicate more severe misophonia symptoms, with a range of 0-50 for each subscale.

  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).

• Change in misophonia symptoms measured by S-Five - Impact subscale

  S-Five is a validated questionnaire used in Poland to assess misophonia symptoms. Higher values indicate more severe misophonia symptoms, with a range of 0-50 for each subscale.

  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).

• CHange in misophonia symptoms measured by S-Five - Outburst subscale

  S-Five is a validated questionnaire used in Poland to assess misophonia symptoms. Higher values indicate more severe misophonia symptoms, with a range of 0-50 for each subscale.

  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).

• Change of aversiveness rating (valence/pleasure) on the Manikin Scales.

  Manikin Scales are commonly used scales to assess emotional valence. Range: 1-5. Higher values indicate higher aversiveness/lower pleasure. A change in ratings during the 'decrease' condition, compared to the 'look' condition is expected. This change is expected to be more pronounced in the post-treatment assessment than at the baseline assessment (before therapy), particularly regarding misophonic triggers. No changes are anticipated in the control group.

  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).

• Change of arousal rating on the Manikin Scales.

  Manikin Scales are commonly used scales to assess emotional valence. Range: 1-5. Higher values indicate lower arousal. A change in ratings during the 'decrease' condition, compared to the 'look' condition is expected. This change is expected to be more pronounced in the post-treatment assessment than at the baseline assessment (before therapy), particularly regarding misophonic triggers. No changes are anticipated in the control group.

  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).

• Change in Galvanic Skin Response

  Higher values here indicate arousal linked to misophonic reactions/higher misophnic reaction.

  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).

• Change in average HR during the trigger presentation

  Higher values here indicate arousal linked to misophonic reactions/higher misophnic reaction.

  Baseline vs. post-treatment assessment (which will be performed 5 to 12 weeks since the last session).

• Diagnosis of personality disorders as a predictor of worse treatment outcome.

  Personality disorders will be assessed using the SCID-5-PD (Polish adaptation). It is anticipated that meeting the criteria for a PD (especially higher symptoms OCPD) will be related to poorer treatment outcomes.

  3 to 10 days before the 1st session

• Working Alliance Inventory will be related to better treatment outcomes.

  Higher scores indicate a better quality of relationship with therapist. Range: 12-84.

  3-8 days after the last (the 4th) therapy session (There are 4 weekly sessions throughout one month)

Secondary Outcomes (2)

• Meeting criteria for psychiatric disorders -

  3 to 10 days before the 1st session

• Hearing test - standard and high frequency pure-tone audiometry

  3 to 10 days after the 4st session

Study Arms (2)

Cognitive Reappraisal

EXPERIMENTAL

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.

Behavioral: Cognitive reappraisal

Schultz Autogenic Training

ACTIVE COMPARATOR

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.

Behavioral: Schultz Autogenic Training

Interventions

Cognitive reappraisal 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.

Cognitive Reappraisal

Schultz Autogenic Training 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.

Schultz Autogenic Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Warsaw, Poland: lead
• Duke University: collaborator

Study Sites (1)

Faculty of Psychology, University of Warsaw

Warsaw, Masovian Voivodeship, 00-183, Poland

RECRUITING

MeSH Terms

Conditions

misophonia

Central Study Contacts

Marta Siepsiak, phd

CONTACT

0048661152533; marta.siepsiak@psych.uw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 18, 2024
• Study Start: March 18, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

PL (1)