Social AnxietyNCT05159037
Using the Musical Track From GC-MRT as a Treatment Booster in Stressful Situations
A study testing Gaze Contingent Music Reward Therapy and Music Booster in people with Social Anxiety, run by Tel Aviv University at 1 site in Israel.
Trial summary
The study examines whether musical tracks played during gaze contingent music reward therapy (GC-MRT) for social anxiety could later be used as a booster to reduce anxiety before a stressful situation. 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?
- Gaze Contingent Music Reward Therapy and Music Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Nov 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a signed consent form
- an age of 18 years or above
- a score greater than 60 on LSAS
Who cannot join
- a self-reported history of neurological or psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Musical Track From Gaze-Contingent Music Reward Therapy as a Treatment Booster in Stressful Situations Among Highly Socially Anxious Participants
The study examines whether musical tracks played during gaze contingent music reward therapy (GC-MRT) for social anxiety could later be used as a booster to reduce anxiety before a stressful situation. To this end, highly socially anxious participants will undergo 4 GC-MRT sessions designed to train participants' attention away from threat and towards neutral social stimuli. Subsequently, participants will be asked to perform a socially stressful speech task. Prior to the speech, half of the participants will listen to a musical track the participants were trained with, and half of the participants will listen to a musical track the participants like but were not trained with during the GC-MRT sessions. The investigators expect that listening to musical track taken from the GC-MRT sessions will moderate the increase in anxiety levels prior to the speech and will improve performance during the speech compared to a non-trained musical track.
Read the detailed description
Gaze contingent music reward therapy (GC-MRT) is designed to modify threat-related attention biases through operational conditioning between beloved music and gaze patterns favoring neutral stimuli over threat-related stimuli. GC-MRT has shown efficacy in reducing social anxiety symptoms. The current study is designed to explore whether the musical tracks played during the GC-MRT conditioning could be later used as a treatment booster to reduce anxiety in a socially stressful situation. To this end, 60 high socially anxious participants will undergo four GC-MRT sessions and then will be asked to perform a stressful speech task. Prior to the speech, half of the participants (randomly determined) will listen to a musical track the participants were trained with, and half of the participants will listen to a musical track the participants like but were not trained with during GC-MRT sessions. The investigators expect that the listening to musical track taken from the GC-MRT sessions will moderate the increase in anxiety levels prior to the speech and will improve performance during the speech compared to a non-trained musical track.
- Conditions
- Social Anxiety
- Being tested
- Gaze Contingent Music Reward Therapy, Music Booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze Contingent Music Reward TherapyBehavioural
Feedback according to participants' viewing patterns, in order to modify their attention.
Music BoosterBehavioural
Participants listen to a musical track they ranked as highly liked before a stressful situation
| Study group | Role | What they receive |
|---|---|---|
| Active GC-MRT Booster | Experimental | Following four sessions of Gaze-Contingent Music Reward Therapy training participants' attention away from threats and towards neutral stimuli, participants will listen to a musical track they will have been trained with prior to a stressful speech task. Receives: Behavioral: Gaze Contingent Music Reward Therapy; Behavioral: Music Booster |
| Control Booster | Placebo comparator | Following four sessions of Gaze-Contingent Music Reward Therapy training participants' attention away from threats and towards neutral stimuli, participants will listen to a musical track they will not have been trained with but ranked as highly liked prior to a stressful speech task. Receives: Behavioral: Gaze Contingent Music Reward Therapy; Behavioral: Music Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - the Liebowitz Social Anxiety Scale - Self Reported Version
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations.
Measured: 2 days before intervention, 4-10 days after intervention completion
Change from baseline - the Visual Analogue Scale - Anxiety
The Visual Analogue Scale Anxiety (VAS-A) measures state anxiety. Participants are instructed to use the computer mouse and place the locator at the scale position representing their current level of anxiety in response to the question, "How anxious do you feel right now?". The VAS is divided into thirty units from 0 ("calm") to 30 ("anxious") while the participants do not see the division into calves and are asked to answer according to their feeling.
Measured: 4-10 days after intervention completion (baseline of the speech session, after introducing the speech task, after listening to a musical track, after preparation to the speech,after the speech is over).
Secondary outcomes (1)
PSPS (Public Speaking Performance Scale)
The Public Speaking Performance Scale comprises 17 items concerning speech quality. Items are rated by independent judges on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores denote worse performance.
Measured: 4-10 days after intervention completion (During speech task)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start7 Nov 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159037
- Sponsor's protocol ID
- TAUgcMRTbooster
- Status last verified
- Jun 2022
- First submitted
- 15 Nov 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Musical Track From Gaze-Contingent Music Reward Therapy as a Treatment Booster in Stressful Situations Among Highly Socially Anxious Participants
- ClinicalTrials.gov ID
- NCT05159037
- Acronym / sponsor ID
- TAUgcMRTbooster
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 15 Dec 2021 (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 study examines whether musical tracks played during gaze contingent music reward therapy (GC-MRT) for social anxiety could later be used as a booster to reduce anxiety before a stressful situation. To this end, highly socially anxious participants will undergo 4 GC-MRT sessions designed to train participants' attention away from threat and towards neutral social stimuli. Subsequently, participants will be asked to perform a socially stressful speech task. Prior to the speech, half of the participants will listen to a musical track the participants were trained with, and half of the participants will listen to a musical track the participants like but were not trained with during the GC-MRT sessions. The investigators expect that listening to musical track taken from the GC-MRT sessions will moderate the increase in anxiety levels prior to the speech and will improve performance during the speech compared to a non-trained musical track.
Detailed description
Gaze contingent music reward therapy (GC-MRT) is designed to modify threat-related attention biases through operational conditioning between beloved music and gaze patterns favoring neutral stimuli over threat-related stimuli. GC-MRT has shown efficacy in reducing social anxiety symptoms. The current study is designed to explore whether the musical tracks played during the GC-MRT conditioning could be later used as a treatment booster to reduce anxiety in a socially stressful situation. To this end, 60 high socially anxious participants will undergo four GC-MRT sessions and then will be asked to perform a stressful speech task. Prior to the speech, half of the participants (randomly determined) will listen to a musical track the participants were trained with, and half of the participants will listen to a musical track the participants like but were not trained with during GC-MRT sessions. The investigators expect that the listening to musical track taken from the GC-MRT sessions will moderate the increase in anxiety levels prior to the speech and will improve performance during the speech compared to a non-trained musical track.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active GC-MRT Booster | Experimental | Behavioral: Gaze Contingent Music Reward Therapy, Behavioral: Music BoosterFollowing four sessions of Gaze-Contingent Music Reward Therapy training participants' attention away from threats and towards neutral stimuli, participants will listen to a musical track they will have been trained with prior to a stressful speech task. |
| Control Booster | Placebo comparator | Behavioral: Gaze Contingent Music Reward Therapy, Behavioral: Music BoosterFollowing four sessions of Gaze-Contingent Music Reward Therapy training participants' attention away from threats and towards neutral stimuli, participants will listen to a musical track they will not have been trained with but ranked as highly liked prior to a stressful speech task. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a signed consent form
- an age of 18 years or above
- a score greater than 60 on LSAS
Key exclusion criteria (1 listed)
- a self-reported history of neurological or psychiatric illness
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 |
|---|---|---|
| Gaze Contingent Music Reward TherapyFeedback according to participants' viewing patterns, in order to modify their attention. | Behavioural | Active GC-MRT Booster, Control Booster |
| Music BoosterParticipants listen to a musical track they ranked as highly liked before a stressful situation | Behavioural | Active GC-MRT Booster, Control Booster |
Primary outcome
Change from baseline - the Liebowitz Social Anxiety Scale - Self Reported Version
Time frame: 2 days before intervention, 4-10 days after intervention completion
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations.
Change from baseline - the Visual Analogue Scale - Anxiety
Time frame: 4-10 days after intervention completion (baseline of the speech session, after introducing the speech task, after listening to a musical track, after preparation to the speech,after the speech is over).
The Visual Analogue Scale Anxiety (VAS-A) measures state anxiety. Participants are instructed to use the computer mouse and place the locator at the scale position representing their current level of anxiety in response to the question, "How anxious do you feel right now?". The VAS is divided into thirty units from 0 ("calm") to 30 ("anxious") while the participants do not see the division into calves and are asked to answer according to their feeling.
1 secondary outcome
PSPS (Public Speaking Performance Scale)
Time frame: 4-10 days after intervention completion (During speech task)
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 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze Contingent Music Reward Therapy and Music Booster in people with Social Anxiety, run by Tel Aviv University at 1 site in Israel.
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 3 inclusion and 1 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 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Change from baseline - the Liebowitz Social Anxiety Scale - Self Reported Version (time frame: 2 days before intervention, 4-10 days after intervention completion). 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 22 Jun 2022.