MisophoniaNCT04612374
Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Misophonia, run by Duke University at 1 site in United States.
Trial summary
Despite increasing recognition of misophonia, there are currently no evidence-based treatments to help those who are suffering. Therefore, the primary purpose of this study is to assess the acceptability, feasibility, and preliminary efficacy of a treatment for misophonia. This study will be conducted in two phases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Misophonia
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 4 Aug 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between age 18-65
- Able to read English
- Meet criteria for interfering symptoms of misophonia
- Live in North Carolina
Who cannot join
- Under age 18 or over age 65
- Current mania
- Current psychotic disorder
- Current anorexia
- Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
- Phase 1 participants cannot also participate in Phase 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Despite increasing recognition of misophonia, there are currently no evidence-based treatments to help those who are suffering. Therefore, the primary purpose of this study is to assess the acceptability, feasibility, and preliminary efficacy of a treatment for misophonia. This study will be conducted in two phases. In the Phase 1, participants will receive a treatment the investigators believe can help manage symptoms of misophonia: The Unified Protocol. This treatment uses evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. After treatment, patients will provide feedback about their experience. The investigators will use this feedback to revise the treatment as indicated. In Phase 2, participants will receive the revised treatment and provide feedback on their experience. Throughout treatment in either phase, participants will provide daily and weekly information about their symptoms.
The aims of this study are (1) to explore the acceptability and feasibility of the Unified Protocol for individuals who experience Misophonia and (2) to examine whether this treatment helps reduce symptoms associated with Misophonia.
- Conditions
- Misophonia
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders, Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Keywords
- Misophonia, Treatment
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
Please see arm/group descriptions
Revised Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
Please see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Unified Protocol, 2 week baseline | Experimental | Participants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Phase 1: Experimental: Unified Protocol, 4 week baseline | Experimental | Participants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Phase 2: Revised Unified Protocol, 2 week baseline | Experimental | Participants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1. Receives: Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Phase 2: Revised Unified Protocol, 4 week baseline | Experimental | Participants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1. Receives: Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ
The CEQ is a 6-item measure that asks patients about their perceptions of treatment.
Measured: up to 20 weeks
Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)
The Satisfaction with Therapy and Therapist Scale is a 13-item measure that asks patients about their satisfaction with treatment and with their therapist.
Measured: up to 20 weeks
Number of sessions attended
The number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment
Measured: up to 20 weeks
Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)
The SMQ is a 16-item measure that asks patients about their use of mindfulness skills .
Measured: up to 24 weeks
Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)
The CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment
Measured: up to 24 weeks
Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)
The BAQ is a five item measure that assesses use of behavior change skills taught in treatment.
Measured: up to 24 weeks
Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)
The ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms
Measured: up to 24 weeks
Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)
The BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations
Measured: up to 24 weeks
Change in misophonia symptoms as assessed by the Misophonia Questionnaire
The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities).
Measured: assessed weekly, up to 24 weeks
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
The Overall Anxiety Severity and Impairment Scale is a five item measure that assesses interference and distress related to the experience of anxiety. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
Measured: assessed weekly, up to 24 weeks
Change in depression as measured by the Overall Depression Severity and Impairment Scale
The Overall Depression Severity and Impairment Scale is a five item measure that assesses interference and distress in an individual's day-to-day life related to the experience of depression. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
Measured: assessed weekly, up to 24 weeks
Change in anger as measured by the PANAS Hostility Scale
The PANAS Hostility Scale is a 6 item scale that assesses how often a participant experienced anger in the past week.
Measured: assessed weekly, up to 24 weeks
Secondary outcomes (6)
Number of patients who report a change in attentional control as measured by the Digit Span Test
This test assesses a participant's ability to selectively use their attention during a task
Measured: up to 20 weeks
Number of patients who report a change in attentional control as measured by the Trail Making Test
This test assesses a participant's ability to selectively use their attention during a task
Measured: up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Stroop test
This test assesses a participant's ability to alternate their responses based on instructions.
Measured: up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test
This test assesses a participant's ability to alternate their responses based on instructions.
Measured: up to 20 weeks
Number of seconds participant engaged in a physiological challenge exercise
Participants will be asked to breathe through a small straw, with the option to stop at any time
Measured: up to 20 weeks
Number of seconds participant engaged in a writing task
Participants will be asked to write about emotion-provoking situations, with the option to stop at any time
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start21 Dec 2020
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MisophoniaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Zachary Rosenthal, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612374
- Sponsor's protocol ID
- Pro00106807
- Status last verified
- Feb 2022
- First submitted
- 27 Oct 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
- ClinicalTrials.gov ID
- NCT04612374
- Acronym / sponsor ID
- Pro00106807
- Conditions
- Misophonia
- Keywords
- Misophonia, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 3 Nov 2020 (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.
Despite increasing recognition of misophonia, there are currently no evidence-based treatments to help those who are suffering. Therefore, the primary purpose of this study is to assess the acceptability, feasibility, and preliminary efficacy of a treatment for misophonia. This study will be conducted in two phases. In the Phase 1, participants will receive a treatment the investigators believe can help manage symptoms of misophonia: The Unified Protocol. This treatment uses evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. After treatment, patients will provide feedback about their experience. The investigators will use this feedback to revise the treatment as indicated. In Phase 2, participants will receive the revised treatment and provide feedback on their experience. Throughout treatment in either phase, participants will provide daily and weekly information about their symptoms.
The aims of this study are (1) to explore the acceptability and feasibility of the Unified Protocol for individuals who experience Misophonia and (2) to examine whether this treatment helps reduce symptoms associated with Misophonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Unified Protocol, 2 week baseline | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences. |
| Phase 1: Experimental: Unified Protocol, 4 week baseline | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences. |
| Phase 2: Revised Unified Protocol, 2 week baseline | Experimental | Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1. |
| Phase 2: Revised Unified Protocol, 4 week baseline | Experimental | Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between age 18-65
- Able to read English
- Meet criteria for interfering symptoms of misophonia
- Live in North Carolina
Key exclusion criteria (6 listed)
- Under age 18 or over age 65
- Current mania
- Current psychotic disorder
- Current anorexia
- Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
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 |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersPlease see arm/group descriptions | Behavioural | Phase 1: Experimental: Unified Protocol, 4 week baseline, Phase 1: Unified Protocol, 2 week baseline |
| Revised Unified Protocol for Transdiagnostic Treatment of Emotional DisordersPlease see arm/group descriptions | Behavioural | Phase 2: Revised Unified Protocol, 2 week baseline, Phase 2: Revised Unified Protocol, 4 week baseline |
Primary outcome
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ
Time frame: up to 20 weeks
The CEQ is a 6-item measure that asks patients about their perceptions of treatment.
Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)
Time frame: up to 20 weeks
The Satisfaction with Therapy and Therapist Scale is a 13-item measure that asks patients about their satisfaction with treatment and with their therapist.
Number of sessions attended
Time frame: up to 20 weeks
The number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment
Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)
Time frame: up to 24 weeks
The SMQ is a 16-item measure that asks patients about their use of mindfulness skills .
Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)
Time frame: up to 24 weeks
The CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment
Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)
Time frame: up to 24 weeks
The BAQ is a five item measure that assesses use of behavior change skills taught in treatment.
Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)
Time frame: up to 24 weeks
The ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms
Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)
Time frame: up to 24 weeks
The BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations
Change in misophonia symptoms as assessed by the Misophonia Questionnaire
Time frame: assessed weekly, up to 24 weeks
The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities).
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
Time frame: assessed weekly, up to 24 weeks
The Overall Anxiety Severity and Impairment Scale is a five item measure that assesses interference and distress related to the experience of anxiety. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
Change in depression as measured by the Overall Depression Severity and Impairment Scale
Time frame: assessed weekly, up to 24 weeks
The Overall Depression Severity and Impairment Scale is a five item measure that assesses interference and distress in an individual's day-to-day life related to the experience of depression. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
Change in anger as measured by the PANAS Hostility Scale
Time frame: assessed weekly, up to 24 weeks
The PANAS Hostility Scale is a 6 item scale that assesses how often a participant experienced anger in the past week.
6 secondary outcomes
Number of patients who report a change in attentional control as measured by the Digit Span Test
Time frame: up to 20 weeks
Number of patients who report a change in attentional control as measured by the Trail Making Test
Time frame: up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Stroop test
Time frame: up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test
Time frame: up to 20 weeks
Number of seconds participant engaged in a physiological challenge exercise
Time frame: up to 20 weeks
Number of seconds participant engaged in a writing task
Time frame: up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Misophonia
Recruiting
Transcranial Magnetic Stimulation in Misophonia
Misophonia
Not yet recruitingObservational study
Pain, Central Sensitization, and Misophonia in Lipedema
Lipedema
Not yet recruiting
Effectiveness of a Mindfulness-Based Cognitive Behavioral Mobile Intervention for Misophonia
Misophonia, Misophonia Treatment
RecruitingObservational study
Prevalence of Misophonia in Turkish High School Students
Misophonia
RecruitingEarly Phase 1
Propranolol for Misophonia
Misophonia, Propanolol
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.
M. Zachary Rosenthal, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Misophonia, run by Duke University at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Aug 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ (time frame: up to 20 weeks). The study lists 12 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 16 Aug 2022.