MisophoniaU-HEARNCT04365543
Treatment for Youth (Ages 8 to 16 Years Old) With Misophonia (U-HEAR)
A study testing Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia and Psychoeducation and Relaxation Therapy (PRT) in people with Misophonia, run by University of South Florida at 2 sites in United States.
Trial summary
If someone is really sensitive to certain noises and sounds, they might have misophonia. U-HEAR is a study created to find out what helps kids and teens with misophonia. There are two treatments being tested in this study. The treatment your child receives will be determined at random. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Misophonia
- What is being tested?
- Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia and Psychoeducation and Relaxation Therapy (PRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2020to Dec 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child meets criteria for misophonia
- The child is currently living with their family/guardian(s)
- The child is between 8 and 16 years old
- Parent/legal guardian and child are able to read and speak English without a translator
- Parent/legal guardian is able to attend weekly sessions and all assessments
- If the child is on a psychotropic medication, they will need to be on a stable dose for 4 weeks prior to assessment (2 weeks for stimulant medication)
Who cannot join
- The child has received prior UP-C/A treatment
- The child is acutely suicidal
- The child has a current diagnosis of psychosis, bipolar disorder, intellectual disability, alcohol/substance dependence, or eating disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami
Coral Gables, Florida, 33124
Ashley Karlovich, BA, 305-284-9852 ext. 1, anxietylab@psy.miami.edu
- Recruiting
University of Florida Rothman Center
St. Petersburg, Florida, 33701
Kelly Kudryk, BA, 813-586-1630, kellykudryk@usf.edu
About this study
Official title: Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).
If someone is really sensitive to certain noises and sounds, they might have misophonia. U-HEAR is a study created to find out what helps kids and teens with misophonia. There are two treatments being tested in this study. The treatment your child receives will be determined at random. There will be a Two-Thirds (2/3rds or 66%) chance your child will receive a treatment called the Unified Protocol for Children and Adolescents (UP-C/A) that has been modified to meet the needs for youth with misophonia. There is a One-Third (1/3rd or 33%) chance your child will receive a treatment called Psychoeducation and Relaxation. All participants will get ten free treatment sessions. Each session will last one hour and happen once a week. The aim of the study is to evaluate the feasibility and preliminary efficacy of the UP-C/A for youth with misophonia.
Read the detailed description
Misophonia is a condition characterized by intense affective and/or physical responses to auditory triggers. Negative affective states, including significant distress and avoidance are characteristic of misophonia. These negative emotional responses to trigger sounds, which result in behavioral problems and impairment, may be the primary targets for effective psychosocial intervention for misophonia. Transdiagnostic treatment approaches address clinically-significant distress through the use of evidence-based, cognitive-behavioral techniques (e.g., mindful awareness, problem-solving, and opposite action strategies) that allow for flexible and personalized treatment of core dysfunctions that cut across emotional disorders and lead to on-going impairment. This type of evidence-based, transdiagnostic approach includes skills applicable for problems observed frequently in misophonia including adaptability, problem solving, emotional (arousal) dysregulation and poor distress tolerance. The hypothesized mechanism of change of these core-dysfunction focused treatments is increased tolerance of distress in response to strong or intense emotion states. A secondary target is the reduction of maladaptive emotional behaviors (e.g., avoidance, aggression, escape) that may reinforce distress over time. To that end, this proposal aims to evaluate the feasibility and preliminary efficacy of the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia. We will compare UP-C/A in a 2:1 ratio against a comparison condition (PRT: psychoeducation plus relaxation training), a behavioral approach that represents usual treatment in the community and has been utilized in clinical trials (35% response rate).
- Conditions
- Misophonia
- Being tested
- Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia, Psychoeducation and Relaxation Therapy (PRT)
- Keywords
- misophonia, sensory sensitivity, anxiety, sound
- Medical subject headings
- misophonia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophoniaBehavioural
Please see arm/group descriptions
Psychoeducation and Relaxation Therapy (PRT)Behavioural
Please see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| UP-C/A for Misophonia | Experimental | The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) are manualized treatments for treating emotional disorders in youth. We have modified the UP-C/A to meet the needs for youth with misophonia. Receives: Behavioral: Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia |
| Psychoeducation and Relaxation Therapy | Experimental | Psychoeducation and Relaxation Therapy (PRT) is a treatment that educates the child on misophonia and provides training in relaxation skills and tools for calming panic, anxiety and anger feelings. Receives: Behavioral: Psychoeducation and Relaxation Therapy (PRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks)
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 5 weeks of treatment.
Measured: 5 weeks
Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks)
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 10 weeks of treatment.
Measured: 10 weeks
Severity of symptoms measured by Clinical Global Impression - Severity (Baseline)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). Severity will be measured before treatment begins to create a baseline for each participant.
Measured: Baseline
Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 5 weeks of treatment.
Measured: 5 weeks
Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks)
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 10 weeks of treatment.
Measured: 5 weeks
Overall impairment measured by Child's Global Assessment Scale (Baseline)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100. General functioning of the participant will be measured before treatment begins to create a baseline for each subject.
Measured: Baseline
Overall impairment measured by Child's Global Assessment Scale (5 weeks)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 5 weeks of treatment.
Measured: 5 weeks
Overall impairment measured by Child's Global Assessment Scale (10 weeks)
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 10 weeks of treatment.
Measured: 10 weeks
Secondary outcomes (6)
Misophonia symptoms as measured by Misophonia Assessment Questionnaire
Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds.
Measured: Baseline
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds.
Measured: 5 weeks
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds.
Measured: 10 weeks
Misophonia symptoms as measured by 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). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score.
Measured: Baseline
Change in misophonia symptoms as measured by 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). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score.
Measured: 5 weeks
Change in misophonia symptoms as measured by 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). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start8 Apr 2020
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
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 University of South FloridaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, Adam Lewin, University of South Florida
- Investigators
- Adam Lewin, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365543
- Sponsor's protocol ID
- Pro#00042498
- Acronym
- U-HEAR
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sponsor requests de-identified data as a grant requirement in order to better the understand of misophonia. At the conclusion of the study, we will provide the de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).
- ClinicalTrials.gov ID
- NCT04365543
- Acronym / sponsor ID
- U-HEAR / Pro#00042498
- Conditions
- Misophonia
- Keywords
- misophonia, sensory sensitivity, anxiety, sound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Apr 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.
If someone is really sensitive to certain noises and sounds, they might have misophonia. U-HEAR is a study created to find out what helps kids and teens with misophonia. There are two treatments being tested in this study. The treatment your child receives will be determined at random. There will be a Two-Thirds (2/3rds or 66%) chance your child will receive a treatment called the Unified Protocol for Children and Adolescents (UP-C/A) that has been modified to meet the needs for youth with misophonia. There is a One-Third (1/3rd or 33%) chance your child will receive a treatment called Psychoeducation and Relaxation. All participants will get ten free treatment sessions. Each session will last one hour and happen once a week. The aim of the study is to evaluate the feasibility and preliminary efficacy of the UP-C/A for youth with misophonia.
Detailed description
Misophonia is a condition characterized by intense affective and/or physical responses to auditory triggers. Negative affective states, including significant distress and avoidance are characteristic of misophonia. These negative emotional responses to trigger sounds, which result in behavioral problems and impairment, may be the primary targets for effective psychosocial intervention for misophonia. Transdiagnostic treatment approaches address clinically-significant distress through the use of evidence-based, cognitive-behavioral techniques (e.g., mindful awareness, problem-solving, and opposite action strategies) that allow for flexible and personalized treatment of core dysfunctions that cut across emotional disorders and lead to on-going impairment. This type of evidence-based, transdiagnostic approach includes skills applicable for problems observed frequently in misophonia including adaptability, problem solving, emotional (arousal) dysregulation and poor distress tolerance. The hypothesized mechanism of change of these core-dysfunction focused treatments is increased tolerance of distress in response to strong or intense emotion states. A secondary target is the reduction of maladaptive emotional behaviors (e.g., avoidance, aggression, escape) that may reinforce distress over time. To that end, this proposal aims to evaluate the feasibility and preliminary efficacy of the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia. We will compare UP-C/A in a 2:1 ratio against a comparison condition (PRT: psychoeducation plus relaxation training), a behavioral approach that represents usual treatment in the community and has been utilized in clinical trials (35% response rate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UP-C/A for Misophonia | Experimental | Behavioral: Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophoniaThe Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) are manualized treatments for treating emotional disorders in youth. We have modified the UP-C/A to meet the needs for youth with misophonia. |
| Psychoeducation and Relaxation Therapy | Experimental | Behavioral: Psychoeducation and Relaxation Therapy (PRT)Psychoeducation and Relaxation Therapy (PRT) is a treatment that educates the child on misophonia and provides training in relaxation skills and tools for calming panic, anxiety and anger feelings. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The child meets criteria for misophonia
- The child is currently living with their family/guardian(s)
- The child is between 8 and 16 years old
- Parent/legal guardian and child are able to read and speak English without a translator
- Parent/legal guardian is able to attend weekly sessions and all assessments
Key exclusion criteria (3 listed)
- The child has received prior UP-C/A treatment
- The child is acutely suicidal
- The child has a current diagnosis of psychosis, bipolar disorder, intellectual disability, alcohol/substance dependence, or eating disorder
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 Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophoniaPlease see arm/group descriptions | Behavioural | UP-C/A for Misophonia |
| Psychoeducation and Relaxation Therapy (PRT)Please see arm/group descriptions | Behavioural | Psychoeducation and Relaxation Therapy |
Primary outcome
Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks)
Time frame: 5 weeks
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 5 weeks of treatment.
Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks)
Time frame: 10 weeks
Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 10 weeks of treatment.
Severity of symptoms measured by Clinical Global Impression - Severity (Baseline)
Time frame: Baseline
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). Severity will be measured before treatment begins to create a baseline for each participant.
Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks)
Time frame: 5 weeks
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 5 weeks of treatment.
Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks)
Time frame: 5 weeks
Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 10 weeks of treatment.
Overall impairment measured by Child's Global Assessment Scale (Baseline)
Time frame: Baseline
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100. General functioning of the participant will be measured before treatment begins to create a baseline for each subject.
Overall impairment measured by Child's Global Assessment Scale (5 weeks)
Time frame: 5 weeks
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 5 weeks of treatment.
Overall impairment measured by Child's Global Assessment Scale (10 weeks)
Time frame: 10 weeks
Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 10 weeks of treatment.
6 secondary outcomes
Misophonia symptoms as measured by Misophonia Assessment Questionnaire
Time frame: Baseline
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
Time frame: 5 weeks
Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
Time frame: 10 weeks
Misophonia symptoms as measured by Misophonia Questionnaire
Time frame: Baseline
Change in misophonia symptoms as measured by Misophonia Questionnaire
Time frame: 5 weeks
Change in misophonia symptoms as measured by Misophonia Questionnaire
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Yes. The sponsor requests de-identified data as a grant requirement in order to better the understand of misophonia. At the conclusion of the study, we will provide the de-identified data.
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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.
Adam Lewin, PhD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia and Psychoeducation and Relaxation Therapy (PRT) in people with Misophonia, run by University of South Florida at 2 sites 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 6 inclusion and 3 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Kudryk, BA (813-586-1630, kellykudryk@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks) (time frame: 5 weeks). The study lists 8 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 28 Apr 2020.