Anxiety Disorders and SymptomsPTLNCT03437317
Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence.
A study testing Perceptual Retraining and Gender Discrimination in people with Anxiety Disorders and Symptoms and Social Anxiety Disorder, run by Florida State University.
Trial summary
The Perceptual Training Study is a series of studies performed with the purpose of identifying a potential avenue for treatment of mood disorders, particularly anxiety-based mood disorders. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms, Social Anxiety Disorder
- What is being tested?
- Perceptual Retraining and Gender Discrimination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 15 Dec 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
- Normal or corrected-to-normal vision
Who cannot join
- History of a diagnosed neurological or Diagnostic and Statistical Manual of Mental Disorders - IV Axis I disorder
- Currently taking prescribed psychoactive drugs, including anti-depressants or anxiolytics.
- Having electrically, magnetically, or mechanically activated implants (e.g. cardiac pacemakers), due to incompatibility with MRI and MEG systems.
- Pregnancy or suspected pregnancy
About this study
The Perceptual Training Study is a series of studies performed with the purpose of identifying a potential avenue for treatment of mood disorders, particularly anxiety-based mood disorders. The underlying theme is that neural representations may be threat-oriented, and may also be generalized to non-threatening cues by means of similarity to threatening representations. These may result in anxiety symptoms from innocuous cues. The idea behind the perceptual training is to create a divorce between the threat representations and cues which should be considered non-threatening, enhancing perceptual acuity and potentially reducing anxiety symptoms.
- Being tested
- Perceptual Retraining, Gender Discrimination
- Keywords
- Social Anxiety, Threat processing, Magnetoencephalography (MEG)
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual RetrainingBehavioural
Participants viewed faces varying in their expression of anger and were asked to identify if the face was angry or neutral via button press. Participants were provided with feedback if their categorization of the face as neutral or angry was correct. Each participant was assigned 4 levels of angry faces based on their decision point of anger detection in faces. Faces were selected based on the closest existing anger morph to the category boundary; for example, a decision point of 40% anger was closest to the 38% anger face, and so the faces used would have been 17%, 31%, 45%, and 59% anger. For this example, responses of "neutral" to the 31% angry face would be marked as correct, whereas a similar response to the 45% angry face would be incorrect, as it was above their decision point.
Gender DiscriminationBehavioural
Participants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press.
| Study group | Role | What they receive |
|---|---|---|
| Active - MEG | Experimental | Participants completed 1 session of 8 Perceptual Retraining blocks following an instructional presentation. Receives: Behavioral: Perceptual Retraining |
| Control - MEG | Sham comparator | Participants completed 1 session of 8 blocks of Gender Discrimination Task. Receives: Behavioral: Gender Discrimination |
| Active - 3 Behavior/EEG | Experimental | Participants completed 3 sessions of Perceptual Retraining following an instructional presentation. The first session included 6 blocks of perceptual training, and the second session included 12 blocks of perceptual training. No perceptual training was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart. Receives: Behavioral: Perceptual Retraining |
| Active - 1 Behavior/MEG | Experimental | Participants completed 1 session of 6 Perceptual Retraining blocks following an instructional presentation. Receives: Behavioral: Perceptual Retraining |
| Control - 3 Behavior/MEG | Sham comparator | Participants completed 3 sessions of a Gender Discrimination Task. The first session included 6 blocks of gender discrimination task, and the second session included 12 blocks of the gender discrimination task. No gender discrimination task was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart. Receives: Behavioral: Gender Discrimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Evidence for Categorical Perception Changes
Participants will be asked to respond if they detected anger in faces varying in their levels of anger expression. This task is used to determine a perceptual bias for threat/anger in faces that is related to increases in social anxiety symptoms, and assess for improvements in the categorization of angry vs. neutral faces. that align with modulations of neural responses (MEG and EEG evidence) indexing perceptual processing of the faces following perceptual retraining.
Measured: Baseline to Study Completion (14 to 28 Days)
Neural Evidence for Categorical Perception Changes
Neural activity will be recorded using EEG and MEG to measure neural processes underpinning categorical perception of anger in faces. Changes in this neural perceptual index will be assessed following perceptual retraining to provide a neural mechanism underpinning behavioral improvements in perceptual categorization and subsequent reductions in anxiety.
Measured: Baseline to Study Completion (14 to 28 Days)
Secondary outcomes (2)
Social Anxiety Symptoms - Social Phobia Scale
Change in social anxiety symptomatology through perceptual retraining
Measured: Baseline to Study Completion (14 to 28 Days)
Social Anxiety Symptoms - Liebowitz Social Anxiety Scale
Change in social anxiety symptomatology through perceptual retraining
Measured: Baseline to Study Completion (14 to 28 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Nov 2014
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- More trials run by Florida State 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
- Parallel groups
- Model description
- Participants were randomly assigned to either an active training group or a control group. The active participants completed 8 blocks of a perceptual training task, while the control group performed 8 blocks of a gender discrimination task that received the perceptual retraining protocol
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Principal investigator, Wen Li, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437317
- Sponsor's protocol ID
- PTL-2017.21521
- Acronym
- PTL
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence.
- ClinicalTrials.gov ID
- NCT03437317
- Acronym / sponsor ID
- PTL / PTL-2017.21521
- Keywords
- Social Anxiety, Threat processing, Magnetoencephalography (MEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 19 Feb 2018 (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.
The Perceptual Training Study is a series of studies performed with the purpose of identifying a potential avenue for treatment of mood disorders, particularly anxiety-based mood disorders. The underlying theme is that neural representations may be threat-oriented, and may also be generalized to non-threatening cues by means of similarity to threatening representations. These may result in anxiety symptoms from innocuous cues. The idea behind the perceptual training is to create a divorce between the threat representations and cues which should be considered non-threatening, enhancing perceptual acuity and potentially reducing anxiety symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Participants were randomly assigned to either an active training group or a control group. The active participants completed 8 blocks of a perceptual training task, while the control group performed 8 blocks of a gender discrimination task that received the perceptual retraining protocol
| Arm | Type | Receives |
|---|---|---|
| Active - MEG | Experimental | Behavioral: Perceptual RetrainingParticipants completed 1 session of 8 Perceptual Retraining blocks following an instructional presentation. |
| Control - MEG | Sham comparator | Behavioral: Gender DiscriminationParticipants completed 1 session of 8 blocks of Gender Discrimination Task. |
| Active - 3 Behavior/EEG | Experimental | Behavioral: Perceptual RetrainingParticipants completed 3 sessions of Perceptual Retraining following an instructional presentation. The first session included 6 blocks of perceptual training, and the second session included 12 blocks of perceptual training. No perceptual training was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart. |
| Active - 1 Behavior/MEG | Experimental | Behavioral: Perceptual RetrainingParticipants completed 1 session of 6 Perceptual Retraining blocks following an instructional presentation. |
| Control - 3 Behavior/MEG | Sham comparator | Behavioral: Gender DiscriminationParticipants completed 3 sessions of a Gender Discrimination Task. The first session included 6 blocks of gender discrimination task, and the second session included 12 blocks of the gender discrimination task. No gender discrimination task was performed in session 3. Sessions were spaced approximately 7 days apart, with a minimum of 3 days and a maximum of 14 days apart. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right-handed
- Normal or corrected-to-normal vision
Key exclusion criteria (4 listed)
- History of a diagnosed neurological or Diagnostic and Statistical Manual of Mental Disorders - IV Axis I disorder
- Currently taking prescribed psychoactive drugs, including anti-depressants or anxiolytics.
- Having electrically, magnetically, or mechanically activated implants (e.g. cardiac pacemakers), due to incompatibility with MRI and MEG systems.
- Pregnancy or suspected pregnancy
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 |
|---|---|---|
| Perceptual RetrainingParticipants viewed faces varying in their expression of anger and were asked to identify if the face was angry or neutral via button press. Participants were provided with feedback if their categorization of the face as neutral or angry was correct. Each participant was assigned 4 levels of angry faces based on their decision point of anger detection in faces. Faces were selected based on the closest existing anger morph to the category boundary; for example, a decision point of 40% anger was closest to the 38% anger face, and so the faces used would have been 17%, 31%, 45%, and 59% anger. For this example, responses of "neutral" to the 31% angry face would be marked as correct, whereas a similar response to the 45% angry face would be incorrect, as it was above their decision point. | Behavioural | Active - 1 Behavior/MEG, Active - 3 Behavior/EEG, Active - MEG |
| Gender DiscriminationParticipants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press. | Behavioural | Control - 3 Behavior/MEG, Control - MEG |
Primary outcome
Behavioral Evidence for Categorical Perception Changes
Time frame: Baseline to Study Completion (14 to 28 Days)
Participants will be asked to respond if they detected anger in faces varying in their levels of anger expression. This task is used to determine a perceptual bias for threat/anger in faces that is related to increases in social anxiety symptoms, and assess for improvements in the categorization of angry vs. neutral faces. that align with modulations of neural responses (MEG and EEG evidence) indexing perceptual processing of the faces following perceptual retraining.
Neural Evidence for Categorical Perception Changes
Time frame: Baseline to Study Completion (14 to 28 Days)
Neural activity will be recorded using EEG and MEG to measure neural processes underpinning categorical perception of anger in faces. Changes in this neural perceptual index will be assessed following perceptual retraining to provide a neural mechanism underpinning behavioral improvements in perceptual categorization and subsequent reductions in anxiety.
2 secondary outcomes
Social Anxiety Symptoms - Social Phobia Scale
Time frame: Baseline to Study Completion (14 to 28 Days)
Social Anxiety Symptoms - Liebowitz Social Anxiety Scale
Time frame: Baseline to Study Completion (14 to 28 Days)
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 19 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety Disorders and Symptoms
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual Retraining and Gender Discrimination in people with Anxiety Disorders and Symptoms and Social Anxiety Disorder, run by Florida State University.
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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Behavioral Evidence for Categorical Perception Changes (time frame: Baseline to Study Completion (14 to 28 Days)). 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 19 Feb 2018.