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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05159037
Other study ID # TAUgcMRTbooster
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2021
Est. completion date June 20, 2022

Study information

Verified date June 2022
Source Tel Aviv University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 20, 2022
Est. primary completion date June 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - a signed consent form - an age of 18 years or above - a score greater than 60 on LSAS Exclusion Criteria: - a self-reported history of neurological or psychiatric illness

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.
Music Booster
Participants listen to a musical track they ranked as highly liked before a stressful situation

Locations

Country Name City State
Israel Tel Aviv University Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline - viewing patterns on threat-neutral face matrices Gaze patterns, and specifically attention allocation to threat will be used as moderators for clinical outcome, as well as indicators of target engagement. At the first day of intervention, 4-10 days after intervention completion
Primary 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. 2 days before intervention, 4-10 days after intervention completion
Primary 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. 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 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. 4-10 days after intervention completion (During speech task)
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