MisophoniaNCT04198597
Exploring Two Treatments for Misophonia
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Process-based Cognitive Behavioral Therapy in people with Misophonia, run by Duke University at 1 site in United States.
Trial summary
While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Misophonia
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Process-based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2020to 21 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18
- Able to read English
- Meet criteria for interfering symptoms of misophonia
- Live in North Carolina
Who cannot join
- Under age 18
- Current mania
- Current psychotic disorder
- Current anorexia
- Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
- Has received any treatment specifically for misophonia in the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: Exploring Two CBT-based Treatments as Interventions for Emotion Dysregulation in Misophonia
While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use 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. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help reduce symptoms associated with Misophonia.
- Conditions
- Misophonia
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders, Process-based Cognitive Behavioral Therapy
- 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
Process-based Cognitive Behavioral TherapyBehavioural
Please see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| 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 |
| Process-based treatment, 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized. Receives: Behavioral: Process-based Cognitive Behavioral Therapy |
| Process-based treatment, 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized. Receives: Behavioral: Process-based Cognitive Behavioral Therapy |
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)
This form has two questions that assess how satisfied patients were with treatment and how acceptable treatment was to them. The remaining three items are open ended questions that allow patients to provide narrative feedback about their experience in treatment.
Measured: up to 20 weeks
Secondary outcomes (5)
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 Clinical Anger Scale
The Clinical Anger Scale is a 21-item measure that assesses the severity of anger-related symptoms (e.g., current anger, anger about the future).Items are scored from 0 to 3 and summed to produce a total score (ranging from 0 - 63), with higher scores indicating greater anger-related symptoms.
Measured: assessed weekly, up to 24 weeks
Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire
The Skill Use Questionnaire is a four-item measure that assesses the extent to which patients use the skills taught in therapy and find them to be helpful.
Measured: assessed weekly, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start11 Sep 2020
- Primary completion21 Nov 2022
- Study completion21 Nov 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary Rosenthal, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198597
- Sponsor's protocol ID
- Pro00103962
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2019
- Last updated
- 25 Nov 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 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Two CBT-based Treatments as Interventions for Emotion Dysregulation in Misophonia
- ClinicalTrials.gov ID
- NCT04198597
- Acronym / sponsor ID
- Pro00103962
- Conditions
- Misophonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 13 Dec 2019 (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.
While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use 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. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help 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 |
|---|---|---|
| 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. |
| 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. |
| Process-based treatment, 2 week baseline | Experimental | Behavioral: Process-based Cognitive Behavioral TherapyParticipants 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized. |
| Process-based treatment, 4 week baseline | Experimental | Behavioral: Process-based Cognitive Behavioral TherapyParticipants 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over age 18
- Able to read English
- Meet criteria for interfering symptoms of misophonia
- Live in North Carolina
Key exclusion criteria (6 listed)
- Under age 18
- 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 | Unified Protocol, 2 week baseline, Unified Protocol, 4 week baseline |
| Process-based Cognitive Behavioral TherapyPlease see arm/group descriptions | Behavioural | Process-based treatment, 2 week baseline, Process-based treatment, 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
This form has two questions that assess how satisfied patients were with treatment and how acceptable treatment was to them. The remaining three items are open ended questions that allow patients to provide narrative feedback about their experience in treatment.
5 secondary outcomes
Change in misophonia symptoms as assessed by the Misophonia Questionnaire
Time frame: assessed weekly, up to 24 weeks
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
Time frame: assessed weekly, up to 24 weeks
Change in depression as measured by the Overall Depression Severity and Impairment Scale
Time frame: assessed weekly, up to 24 weeks
Change in anger as measured by the Clinical Anger Scale
Time frame: assessed weekly, up to 24 weeks
Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire
Time frame: assessed weekly, up to 24 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 25 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Zachary Rosenthal, Ph.D. 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 Process-based Cognitive Behavioral Therapy 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 25 Nov 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 2 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 25 Nov 2022.