Threat-Related Stimulus Exposure for Stuttering

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Memphis

Disqualifiers: Psychological disorders, Neurological injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how people who stutter respond to threat-related information compared to those who do not stutter. The researchers aim to determine if individuals who stutter focus more on threats, particularly those related to speech, than on neutral stimuli. Participants will complete tasks involving various images or words to monitor their attention patterns. Suitable candidates include English speakers who self-identify as having stuttered, experience mild to severe stuttering, and have no other speech or psychological conditions. As an unphased study, this trial allows participants to contribute to a deeper understanding of stuttering and its psychological aspects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a significant medical history or certain psychological conditions, you may not be eligible to participate.

What prior data suggests that threat-related stimulus exposure is safe for participants?

Research has shown that exposing people to certain stimuli, like words or faces, helps researchers understand their reactions. This method is under study to determine its effect on stuttering.

Studies on stuttering and reactions to threats suggest that people who stutter might pay more attention to threatening stimuli. However, these studies have not identified any major safety issues with this type of exposure. It involves simply looking at different things, which is generally safe and non-invasive.

This clinical trial is marked as "Not Applicable" for phase, indicating it is exploratory. It aims to understand behaviors rather than test a new drug or treatment, suggesting no known safety risks with the exposure method used in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stuttering treatments that often focus on speech therapy techniques, threat-related stimulus exposure targets the psychological aspect of stuttering by using eye-tracking tasks to desensitize individuals to threat-related stimuli. Researchers are excited because this method could address the underlying anxiety associated with stuttering, potentially reducing symptoms more effectively. This innovative approach offers a fresh perspective, aiming to break the cycle of anxiety and stuttering in a way that current therapies do not.

What evidence suggests that threat-related stimulus exposure is effective for stuttering?

Research suggests that gradually facing fears by exposing oneself to stress-inducing situations might help reduce anxiety and improve speech in people who stutter. In this trial, participants will engage in eye-tracking tasks, viewing threat-related and neutral stimuli, such as words or faces, to manage reactions over time. Although direct evidence for this approach specifically for stuttering is limited, it is believed to work by lowering anxiety, which often complicates speaking. Studies have shown that people who stutter can feel anxious about speaking, and this method aims to ease that anxiety by altering stress reactions. While more research is needed, this approach shows promise for improving speech by focusing on emotional responses. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who identify as stutterers, with a mild degree of stuttering or more. They must have normal color vision, speak English primarily, and have at least average nonverbal intelligence and expressive language ability. Excluded are those with significant medical conditions, psychological disorders, reading difficulties, other speech/language disorders besides stuttering, neurological injuries or high scores on depression/anxiety/ADHD scales.

Inclusion Criteria

Additional inclusion criteria for adults who stutter: Self-identification as a person who stutters, Score of at least 11 (mild stuttering) on Stuttering Severity Index, 4th Edition

Normal color vision (based on Ishihara Test, Concise Edition)

Speaks English as their primary language

Exclusion Criteria

Reported significant medical history

Psychological or emotional disorder

Score within clinically significant range for depression on Beck Depression Inventory

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Tasks

Participants complete three experimental tasks: free-viewing task, dot-probe task, and emotional Stroop task to measure attention bias

3 weeks

2 sessions (2-2.5 hours each)

Follow-up

Participants are monitored for safety and effectiveness after experimental tasks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Threat-related stimulus exposure

Trial Overview

The study investigates if adults who stutter pay more attention to threatening information than neutral data. It explores whether this bias is general or specific to threats related to their experiences with stuttering and if it correlates with individual psychological responses among the participants.

How Is the Trial Designed?

Group I: Eye tracking tasks Experimental Treatment 1 Intervention

All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces)

Who Is Running the Clinical Trial?

University of Memphis

Lead Sponsor

Trials

73

Recruited

12,000+

University of Alabama, Tuscaloosa

Collaborator

Trials

49

Recruited

17,900+

Published Research Related to This Trial

A study involving 34 participants who stutter and 34 control participants found that those who stutter have significantly higher anxiety related to social situations, as measured by the Fear of Negative Evaluation Scale, indicating a strong expectation of social harm.

The results suggest that anxiety in people who stutter is specifically linked to social evaluation rather than general anxiety, highlighting the importance of using targeted psychological assessments like the Fear of Negative Evaluation and the Endler Multidimensional Anxiety Scales-Trait in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social anxiety in stuttering: measuring negative social expectancies. Messenger, M., Onslow, M., Packman, A., et al.[2013]

The Premonitory Awareness in Stuttering Scale (PAiS) is a newly developed and validated tool that effectively measures the anticipation of stuttering events in adults who stutter, showing good internal consistency and the ability to distinguish between those who stutter and those who do not.

Higher scores on the PAiS correlate with fewer stuttered syllables, suggesting that individuals who can anticipate their stuttering may be better at managing their speech disruptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Premonitory Awareness in Stuttering Scale (PAiS). Cholin, J., Heiler, S., Whillier, A., et al.[2019]

The study found that when participants encountered a dangerous object in a previous trial, their reaction times improved and errors decreased in subsequent trials involving dangerous objects, indicating enhanced attentional resource allocation.

In contrast, trials preceded by a safe object resulted in longer reaction times and more errors when facing a dangerous object, demonstrating a motor interference effect that was absent when the previous trial was also dangerous.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sequential trial effect based on the motor interference effect from dangerous objects: An ERP study. Liu, P., Wang, X., Cao, G., et al.[2021]

A 3-month study involving 9 individuals who stutter showed that repeated exposure to delayed auditory feedback (DAF) significantly reduced the percentage of stuttered words during non-altered feedback (NAF) conditions.

The results indicate that DAF can effectively improve speech fluency outside of a clinical setting, although the relationship between the length of exposure and fluency improvement may not be straightforward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed auditory feedback in the treatment of stuttering: clients as consumers. Van Borsel, J., Reunes, G., Van den Bergh, N.[2019]

In a study with 20 normal volunteers, the anticipation of electric shocks significantly increased the acoustic startle reflex, indicating heightened anxiety levels during threat conditions compared to no-threat conditions.

The fear-potentiated startle effect grew stronger the longer the threat was anticipated, suggesting that anticipatory anxiety intensifies over time, but it sharply decreased once the threat was removed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the time course of anticipatory anxiety using the fear-potentiated startle reflex. Grillon, C., Ameli, R., Merikangas, K., et al.[2019]

Adults with persistent developmental stuttering (PDS) show normal brain responses to simple tone contrasts but exhibit enhanced brain activity in response to phonetic contrasts, indicating abnormal processing of speech sounds.

This enhanced brain response correlates with the severity of speech disfluency, suggesting that the way the brain represents speech sounds may contribute to the challenges faced by individuals with stuttering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal speech sound representation in persistent developmental stuttering. Corbera, S., Corral, MJ., Escera, C., et al.[2006]

The study demonstrated that prepulse inhibition (PPI) can effectively reduce the startle response in rats when a less frequent 'oddball' speech sound precedes a startling noise, indicating its potential for studying complex sound discrimination.

PPI was shown to be a promising method for assessing the ability to discriminate between different speech sounds, providing quicker and more informative results compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential reductions in acoustic startle document the discrimination of speech sounds in rats. Floody, OR., Kilgard, MP.[2021]

The study found that predictable electric shocks enhanced the startle reflex more than unpredictable shocks, indicating that the predictability of a threat significantly influences fear responses.

Visual cues that did not signal when shocks would occur still increased startle reactions, suggesting that the fear response is dynamically influenced by rapidly changing information about threats, rather than just attention to the cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Startle potentiation in rapidly alternating conditions of high and low predictability of threat. Mol, N., Baas, JM., Grillon, C., et al.[2019]

The study involved 13 phobic individuals and 14 control subjects to assess their responses to a threat stimulus using manual muscle testing, revealing poor reliability in the results before controlling for confounding variables.

After adjusting for factors like musculoskeletal and attentional variables, the validity of muscle testing improved significantly to 91%, suggesting that these factors are crucial for accurately measuring emotional arousal in response to threats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary inquiry into manual muscle testing response in phobic and control subjects exposed to threatening stimuli. Peterson, KB.[2007]

In a study with 9 volunteers, anticipatory anxiety significantly increased the amplitude and decreased the latency of the acoustic startle reflex, indicating that anxiety can be objectively measured in humans.

This method of measuring the startle reflex during anxiety anticipation could help researchers explore the neurobiological mechanisms of anxiety disorders and test potential treatments, leveraging existing knowledge from animal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear-potentiated startle in humans: effects of anticipatory anxiety on the acoustic blink reflex. Grillon, C., Ameli, R., Woods, SW., et al.[2021]

In a study involving 13 adults who stutter (AWS) and 10 adults who do not stutter (ANS), it was found that AWS had significantly decreased lip aperture movement control under external attentional focus conditions, especially during high social stress situations.

AWS exhibited slower tongue movements across all conditions, indicating that social stress impacts their speech motor control, but the type of attentional focus (internal vs. external) specifically affected lip movements rather than tongue movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of attentional focus on speech motor control in adults who stutter with and without social evaluative threat. Bauerly, KR., Mefferd, A.[2023]

The 'Threat-of-Scream' paradigm effectively induces anxiety in participants without ethical concerns associated with physical shocks, as it uses low-intensity screams instead.

In two studies, participants showed increased anxiety levels and physiological responses (skin conductance) during threat conditions compared to safe conditions, indicating that this method can sustain anxiety responses over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'Threat of Scream' paradigm: a tool for studying sustained physiological and subjective anxiety. Beaurenaut, M., Tokarski, E., Dezecache, G., et al.[2021]

Citations

1.

withpower.com

withpower.com/trial/phase-stuttering-8-2023-6c2d9

Threat-Related Stimulus Exposure for Stuttering

This implies that addressing these fears through exposure to threat-related stimuli might help reduce anxiety and improve speech fluency.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0094730X13000909

Anxiety and speaking in people who stutter

This exploratory study examined whether people who stutter (PWS), who can be anxious when speaking, show similar bias and whether reactions to threat words ...

3.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK338610/

Extraction tables clinical effectiveness studies - NCBI - NIH

Frequency of stuttering: group means and SDs – baseline 1, mean 8.62%, SD 3.73, and baseline 2, mean 8.28%, SD 3.74%. Using device during call led to reduction ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4031757/

Emotional reactivity and regulation associated with fluent ...

The purpose of this study was to assess the relation between emotional reactivity and regulation associated with fluent and stuttered utterances of preschool- ...

5.

mdpi.com

mdpi.com/2076-3425/13/2/309

Effects of Binaural Beat Stimulation in Adults with Stuttering

We show for the first time that auditory binaural beat stimulation can improve speech fluency in AWS, and its effect is proportional to boost in EEG β-band ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11626403/

Characteristics associated with social anxiety in adults ...

People who stutter are at a higher risk for developing symptoms of social anxiety, with up to 22–60% of adults who stutter (AWS) meeting ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0094730X14000084

The impact of threat and cognitive stress on speech motor ...

... threat (anxiety) related influences. In the current ... stutter specific threatening stimuli, but not for words that individuals actually stuttered on.

8.

researchgate.net

researchgate.net/publication/305609125_The_Effects_of_Safety_Behaviors_During_Exposure_Therapy_for_Anxiety_Critical_Analysis_from_an_Inhibitory_Learning_Perspective

(PDF) The Effects of Safety Behaviors During Exposure ...

danger from safety behaviors may not maximize inhibitory learning as a consequence. Safety behaviors increase perception of threatening stimuli. Hypervigilance ...

9.

neurologylive.com

neurologylive.com/view/key-risk-factors-individualized-treatment-approaches-early-childhood-stuttering

Key Risk Factors and Individualized Treatment Approaches ...

What are the key risk factors clinicians look for when evaluating early childhood stuttering? Lisa LaSalle, PhD: The child being male, ...