Social AnxietyABMTNCT03601377
Attention Bias Modification Treatment in Social Anxiety
A study testing Training away from threat and Training towards threat in people with Social Anxiety, run by University of Cyprus at 1 site in Cyprus.
Trial summary
This study evaluates attention modification in social anxiety and It is comprised by 2 experiments. At experiment 1 socially anxious participants will receive either training away from threatening faces or placebo intervention and at experiment 2 they will receive either one of these 2 groups or training towards… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Training away from threat and Training towards threat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCyprus
- Study dates
- 3 Oct 2016to 30 Sep 2018
- 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
- 1) highly socially anxious students (based on self-report questionnaire)
Who cannot join
- suicidal intent,
- substance abuse,
- primary diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder,
- or past schizophrenia, bipolar disorder, organic mental disorder,
- any concurrent psychotherapy,
- changes in medication during the 12 weeks prior to study and
- CBT therapy 6 months before the beginning of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Bias Modification Treatment in Social Anxiety: Avoidance or Exposure to Threatening Faces? The Role of Pre-existing Attentional Biases and State Anxiety
This study evaluates attention modification in social anxiety and It is comprised by 2 experiments. At experiment 1 socially anxious participants will receive either training away from threatening faces or placebo intervention and at experiment 2 they will receive either one of these 2 groups or training towards threatening faces. At experiment 2 training will be done under state anxiety levels (video-recording of a speech). Anxiety levels (self-reports, physiological and behavioral measures) as well as attentional biases changes will be examined at pre and post - intervention levels plus 6 months follow-up only for experiment 1.
Read the detailed description
Social anxiety is a highly prevalent disorder in the population. Even though there are effective interventions that can help people who suffer from it, many of them do not seek or receive an evidence-based, face to face treatment. According to cognitive models, attention to social threat is one of the principles that maintain social anxiety. In fact, individuals with social anxiety present attention bias to threat stimuli. However, there is inconsistency in the literature with regards to attentional biases that individuals with anxiety present. A recent model is the vigilance-avoidance hypothesis, in which socially anxious initially focus on the threat and then they avoid it. Therefore, better understanding and then aiming to modify these attentional biases in a computerized manner, with minimal therapist interaction can be a novel and promising way to treat social anxiety, even among patients who avoid presenting for therapy.
Two experiments are aiming to shed some light with regards to the effect of attention bias modification treatment in individuals with social anxiety, taking into consideration the previous mixed results. The first experiment compares training attention to be directed away from threat with a placebo treatment. Approximately 60 socially anxious individuals are randomly allocated in the 2 groups. A structured interview and self-report assessment are done pre-treatment, post-treatment and 6 months follow-up.
The second experiment adds a third group of training towards threat (i.e. exposure), investigating if changing attentional avoidance can also affect anxiety levels. Moreover, the second experiment attempts to improve the typical attention modification paradigm by targeting treatment to participants' identified pre-experimental attentional biases. In addition, predictors of treatment effectiveness will be studied and particularly pre-intervention attentional biases as well as state anxiety. Participants are approximately 90 adults with social phobia who are randomly allocated in treatment and placebo groups. In experiment 2 participants will also be assessed behaviourally as well as physiologically to better demonstrate that anxiety reactions to anxiogenic situations have been reduced between pre and post treatment and that they are smaller than those of a placebo control group.
It is expected that participants in the intervention groups will show reduced attentional bias and social anxiety symptoms in comparison with the placebo group in both studies. In addition, the kind of pre-intervention bias as well as state anxiety will moderate anxiety changes. This study will enrich existing research on attention bias modification treatment by shedding light into potential mechanisms of change and will examine ways to improve the efficacy of this intervention.
- Conditions
- Social Anxiety
- Being tested
- Training away from threat, Training towards threat, Placebo
- Keywords
- attention bias, treatment predictors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training away from threatBehavioural
Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
Training towards threatBehavioural
Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
PlaceboBehavioural
Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
| Study group | Role | What they receive |
|---|---|---|
| Training away from threat | Experimental | Experiment 1 and 2: In the intervention group -training away from threat-, in all angry-neutral faces presentation the probe is presented only after neutral face. Probe type (< or >) is not factorially counterbalanced but there is equal possibility of presentation for each of the following: angry-face location, probe location, or actor.
Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) Receives: Behavioral: Training away from threat |
| Training towards threat | Experimental | Only for Experiment 2: The second ABMT condition -training towards threat- is identical to the first one with the exception that in all angry-neutral face presentations the symbol is presented only after threat face. In addition, at the beginning of every session participants will be informed that a random number of participants will have to repeat their speech. They will also be informed that this instruction will be given right after the dot probe task completion. This will be done in order for the participants to maintain their state anxiety but repetition of the speech task will not actually happen at this stage.
Experiment 2: received 4 times (2 times for 2 weeks) Receives: Behavioral: Training towards threat |
| Placebo | Placebo comparator | Experiment 1 and 2: In the placebo group, angry-face location, probe location and actor are fully counterbalanced with regards to their presentation.
Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Anxiety levels
Experiment 1 \& 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.
Measured: Pre-treatment (day 1)
Social Anxiety changes
Experiment 1 \& 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Measured: Experiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment)
Social Anxiety changes
Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Measured: 6 months after day 1 (Follow-up)
Attentional Biases
For experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).
For experiment 2: Assess kind of attentional biases using the eye-tracking task (measuring eye gaze).
Measured: Pre-treatment (day 1)
Attentional Biases changes
For experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).
For experiment 2: Assess kind of attentional biases using the eye-tracking task (measuring eye gaze).
Measured: 4 weeks after the day 1 (Post-treatment)
Attentional Biases changes
Only for experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).
Measured: 6 months after day 1 (Follow-up)
Physical social anxiety levels
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Measured: Pre-treatment (day 1)
Physical social anxiety changes
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Measured: 3 weeks after the day 1 (Post-treatment)
Secondary outcomes (7)
Social Anxiety levels (clinical interview)
Experiment 1 \& 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Measured: Pre-treatment (day 1)
Physical social anxiety levels 1
Only for experiment 2: measured through skin conductance
Measured: Pre-treatment (day 1)
Physical social anxiety levels 2
Only for experiment 2: measured through corrugator supercilii
Measured: Pre-treatment (day 1)
Social anxiety changes
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Measured: 4 weeks after the day 1 (Post-treatment)
Physical social anxiety changes 1
Only for experiment 2: measured through skin conductance
Measured: 3 weeks after the day 1 (Post-treatment)
Social anxiety changes
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Measured: 6 months after day 1 (follow-up)
Physical social anxiety changes 2
Only for experiment 2: measured through corrugator supercilii
Measured: 3 weeks after the day 1 (Post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start3 Oct 2016
- Primary completion31 Jul 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- 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
- Experiment 1: 2 groups (1 intervention and 1 placebo) receive treatment in parallel Experiment 2: 3 groups (2 types of intervention and 1 placebo) receive treatment in parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- Youth Board of Cyprus, Tel Aviv University
- Responsible party
- Principal investigator, Klavdia Neophytou, University of Cyprus
- Investigators
- Georgia Panayiotou, PhD, Study director, Associate Prof., Department of Psychology, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601377
- Sponsor's protocol ID
- ABMT University of Cyprus
- Acronym
- ABMT
- Status last verified
- Oct 2018
- First submitted
- 6 Jun 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amir N, Beard C, Taylor CT, Klumpp H, Elias J, Burns M, Chen X. Attention training in individuals with generalized social phobia: A randomized controlled trial. J Consult Clin Psychol. 2009 Oct;77(5):961-973. doi: 10.1037/a0016685.
PubMed 19803575Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.
PubMed 20456540
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification Treatment in Social Anxiety: Avoidance or Exposure to Threatening Faces? The Role of Pre-existing Attentional Biases and State Anxiety
- ClinicalTrials.gov ID
- NCT03601377
- Acronym / sponsor ID
- ABMT / ABMT University of Cyprus
- Conditions
- Social Anxiety
- Keywords
- attention bias, treatment predictors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- Youth Board of Cyprus, Tel Aviv University
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 26 Jul 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.
This study evaluates attention modification in social anxiety and It is comprised by 2 experiments. At experiment 1 socially anxious participants will receive either training away from threatening faces or placebo intervention and at experiment 2 they will receive either one of these 2 groups or training towards threatening faces. At experiment 2 training will be done under state anxiety levels (video-recording of a speech). Anxiety levels (self-reports, physiological and behavioral measures) as well as attentional biases changes will be examined at pre and post - intervention levels plus 6 months follow-up only for experiment 1.
Detailed description
Social anxiety is a highly prevalent disorder in the population. Even though there are effective interventions that can help people who suffer from it, many of them do not seek or receive an evidence-based, face to face treatment. According to cognitive models, attention to social threat is one of the principles that maintain social anxiety. In fact, individuals with social anxiety present attention bias to threat stimuli. However, there is inconsistency in the literature with regards to attentional biases that individuals with anxiety present. A recent model is the vigilance-avoidance hypothesis, in which socially anxious initially focus on the threat and then they avoid it. Therefore, better understanding and then aiming to modify these attentional biases in a computerized manner, with minimal therapist interaction can be a novel and promising way to treat social anxiety, even among patients who avoid presenting for therapy.
Two experiments are aiming to shed some light with regards to the effect of attention bias modification treatment in individuals with social anxiety, taking into consideration the previous mixed results. The first experiment compares training attention to be directed away from threat with a placebo treatment. Approximately 60 socially anxious individuals are randomly allocated in the 2 groups. A structured interview and self-report assessment are done pre-treatment, post-treatment and 6 months follow-up.
The second experiment adds a third group of training towards threat (i.e. exposure), investigating if changing attentional avoidance can also affect anxiety levels. Moreover, the second experiment attempts to improve the typical attention modification paradigm by targeting treatment to participants' identified pre-experimental attentional biases. In addition, predictors of treatment effectiveness will be studied and particularly pre-intervention attentional biases as well as state anxiety. Participants are approximately 90 adults with social phobia who are randomly allocated in treatment and placebo groups. In experiment 2 participants will also be assessed behaviourally as well as physiologically to better demonstrate that anxiety reactions to anxiogenic situations have been reduced between pre and post treatment and that they are smaller than those of a placebo control group.
It is expected that participants in the intervention groups will show reduced attentional bias and social anxiety symptoms in comparison with the placebo group in both studies. In addition, the kind of pre-intervention bias as well as state anxiety will moderate anxiety changes. This study will enrich existing research on attention bias modification treatment by shedding light into potential mechanisms of change and will examine ways to improve the efficacy of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Experiment 1: 2 groups (1 intervention and 1 placebo) receive treatment in parallel Experiment 2: 3 groups (2 types of intervention and 1 placebo) receive treatment in parallel
| Arm | Type | Receives |
|---|---|---|
| Training away from threat | Experimental | Behavioral: Training away from threatExperiment 1 and 2: In the intervention group -training away from threat-, in all angry-neutral faces presentation the probe is presented only after neutral face. Probe type (< or >) is not factorially counterbalanced but there is equal possibility of presentation for each of the following: angry-face location, probe location, or actor. Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) |
| Training towards threat | Experimental | Behavioral: Training towards threatOnly for Experiment 2: The second ABMT condition -training towards threat- is identical to the first one with the exception that in all angry-neutral face presentations the symbol is presented only after threat face. In addition, at the beginning of every session participants will be informed that a random number of participants will have to repeat their speech. They will also be informed that this instruction will be given right after the dot probe task completion. This will be done in order for the participants to maintain their state anxiety but repetition of the speech task will not actually happen at this stage. Experiment 2: received 4 times (2 times for 2 weeks) |
| Placebo | Placebo comparator | Behavioral: PlaceboExperiment 1 and 2: In the placebo group, angry-face location, probe location and actor are fully counterbalanced with regards to their presentation. Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) highly socially anxious students (based on self-report questionnaire)
Key exclusion criteria (7 listed)
- suicidal intent,
- substance abuse,
- primary diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder,
- or past schizophrenia, bipolar disorder, organic mental disorder,
- any concurrent psychotherapy,
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 |
|---|---|---|
| Training away from threatDot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial. | Behavioural | Training away from threat |
| Training towards threatDot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial. | Behavioural | Training towards threat |
| PlaceboDot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial. | Behavioural | Placebo |
Primary outcome
Social Anxiety levels
Time frame: Pre-treatment (day 1)
Experiment 1 \& 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.
Social Anxiety changes
Time frame: Experiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment)
Experiment 1 \& 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Social Anxiety changes
Time frame: 6 months after day 1 (Follow-up)
Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Attentional Biases
Time frame: Pre-treatment (day 1)
For experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus). For experiment 2: Assess kind of attentional biases using the eye-tracking task (measuring eye gaze).
Attentional Biases changes
Time frame: 4 weeks after the day 1 (Post-treatment)
For experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus). For experiment 2: Assess kind of attentional biases using the eye-tracking task (measuring eye gaze).
Attentional Biases changes
Time frame: 6 months after day 1 (Follow-up)
Only for experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).
Physical social anxiety levels
Time frame: Pre-treatment (day 1)
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Physical social anxiety changes
Time frame: 3 weeks after the day 1 (Post-treatment)
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
7 secondary outcomes
Social Anxiety levels (clinical interview)
Time frame: Pre-treatment (day 1)
Physical social anxiety levels 1
Time frame: Pre-treatment (day 1)
Physical social anxiety levels 2
Time frame: Pre-treatment (day 1)
Social anxiety changes
Time frame: 4 weeks after the day 1 (Post-treatment)
Physical social anxiety changes 1
Time frame: 3 weeks after the day 1 (Post-treatment)
Social anxiety changes
Time frame: 6 months after day 1 (follow-up)
Physical social anxiety changes 2
Time frame: 3 weeks after the day 1 (Post-treatment)
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 30 Oct 2018.
- Background: PubMed 19803575Amir N, Beard C, Taylor CT, Klumpp H, Elias J, Burns M, Chen X. Attention training in individuals with generalized social phobia: A randomized controlled trial. J Consult Clin Psychol. 2009 Oct;77(5):961-973. doi: 10.1037/a0016685.
- Background: PubMed 20456540Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.
- 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.
Georgia Panayiotou, PhD study director
Associate Prof., Department of Psychology, University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training away from threat and Training towards threat in people with Social Anxiety, run by University of Cyprus at 1 site in Cyprus.
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 1 inclusion and 7 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 30 Oct 2018. 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 Cyprus. 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. 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?
Social Anxiety levels (time frame: Pre-treatment (day 1)). 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?
On the ClinicalTrials.gov record for NCT03601377, which also lists 2 linked publications.
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 30 Oct 2018.