Misophonia TreatmentNCT06372405
Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia
A study testing Cognitive reappraisal and Schultz Autogenic Training in people with Misophonia Treatment, run by University of Warsaw, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Misophonia Treatment
- What is being tested?
- Cognitive reappraisal and Schultz Autogenic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePoland
- Study dates
- 18 Mar 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Faculty of Psychology, University of Warsaw
Warsaw, Masovian Voivodeship, 00-183
Marta Siepsiak, PhD, 0048661152533, marta.siepsiak@psych.uw.edu.pl
Marta Siepsiak, PhD
About this study
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)
Read the 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:
- 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.
- 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.
- 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
- Misophonia Treatment
- Being tested
- Cognitive reappraisal, Schultz Autogenic Training
- Keywords
- misophonia, sound over-responsivity, cognitive reappraisal, relaxation training, CBT, psychotherapy, psychophysiology
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive reappraisalBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Schultz Autogenic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 -
Psychiatric disorders will be assessed using a structured interview - the Mini International Neuropsychiatric Interview (Polish adaptation). It is anticipated that meeting the criteria for at least one psychiatric disorder will correlate with higher misophonia symptoms and worse treatment outcomes.
Measured: 3 to 10 days before the 1st session
Hearing test - standard and high frequency pure-tone audiometry
It is predicted that the results of pure-tone audiometry will not be related to either the severity of misophonia symptoms or the treatment outcome. The standard audiometry range is 250Hz to 8kHz, while high-frequency audiometry covers the range from 10kHz to 20kHz.
Measured: 3 to 10 days after the 4st session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start18 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Misophonia TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372405
- Sponsor's protocol ID
- PSP-501/D125/79/00000
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia
- ClinicalTrials.gov ID
- NCT06372405
- Acronym / sponsor ID
- PSP-501/D125/79/00000
- Conditions
- Misophonia Treatment
- Keywords
- misophonia, sound over-responsivity, cognitive reappraisal, relaxation training, CBT, psychotherapy, psychophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of Warsaw, PolandUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Reappraisal | Experimental | Behavioral: Cognitive reappraisalCognitive 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. |
| Schultz Autogenic Training | Active comparator | Behavioral: Schultz Autogenic TrainingSchultz 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive reappraisalCognitive 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. | Behavioural | Cognitive Reappraisal |
| Schultz Autogenic TrainingSchultz 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. | Behavioural | Schultz Autogenic Training |
Primary outcome
Change in misophonia symptoms measured by S-Five - Externalizing subscale
Time frame: 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).
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.
Change in misophonia symptoms measured by S-Five - Internalizing subscale
Time frame: 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).
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.
Change in misophonia symptoms measured by S-Five - Threat subscale
Time frame: 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).
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.
Change in misophonia symptoms measured by S-Five - Impact subscale
Time frame: 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).
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.
CHange in misophonia symptoms measured by S-Five - Outburst subscale
Time frame: 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).
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.
Change of aversiveness rating (valence/pleasure) on the Manikin Scales.
Time frame: 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).
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.
Change of arousal rating on the Manikin Scales.
Time frame: 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).
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.
Change in Galvanic Skin Response
Time frame: 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).
Higher values here indicate arousal linked to misophonic reactions/higher misophnic reaction.
Change in average HR during the trigger presentation
Time frame: Baseline vs. post-treatment assessment (which will be performed 5 to 12 weeks since the last session).
Higher values here indicate arousal linked to misophonic reactions/higher misophnic reaction.
Diagnosis of personality disorders as a predictor of worse treatment outcome.
Time frame: 3 to 10 days before the 1st session
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.
Working Alliance Inventory will be related to better treatment outcomes.
Time frame: 3-8 days after the last (the 4th) therapy session (There are 4 weekly sessions throughout one month)
Higher scores indicate a better quality of relationship with therapist. Range: 12-84.
2 secondary outcomes
Meeting criteria for psychiatric disorders -
Time frame: 3 to 10 days before the 1st session
Hearing test - standard and high frequency pure-tone audiometry
Time frame: 3 to 10 days after the 4st session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive reappraisal and Schultz Autogenic Training in people with Misophonia Treatment, run by University of Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Siepsiak, phd (0048661152533, marta.siepsiak@psych.uw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in misophonia symptoms measured by S-Five - Externalizing subscale (time frame: 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).). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.