Using the Musical Track From GC-MRT as a Treatment Booster in Stressful Situations

Sponsor
Tel Aviv University (Other)
Overall Status
Completed
CT.gov ID
NCT05159037
Collaborator
(none)
60
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gaze Contingent Music Reward Therapy
  • Behavioral: Music Booster
N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Using the Musical Track From Gaze-Contingent Music Reward Therapy as a Treatment Booster in Stressful Situations Among Highly Socially Anxious Participants
Actual Study Start Date :
Nov 7, 2021
Actual Primary Completion Date :
Jun 20, 2022
Actual Study Completion Date :
Jun 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active GC-MRT Booster

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.

Behavioral: Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.

Behavioral: Music Booster
Participants listen to a musical track they ranked as highly liked before a stressful situation

Placebo Comparator: Control Booster

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.

Behavioral: Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.

Behavioral: Music Booster
Participants listen to a musical track they ranked as highly liked before a stressful situation

Outcome Measures

Primary Outcome Measures

  1. Change from baseline - the Liebowitz Social Anxiety Scale - Self Reported Version [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.

  2. Change from baseline - the Visual Analogue Scale - Anxiety [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.

Secondary Outcome Measures

  1. PSPS (Public Speaking Performance Scale) [4-10 days after intervention completion (During speech task)]

    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.

Other Outcome Measures

  1. Change from baseline - viewing patterns on threat-neutral face matrices [At the first day of intervention, 4-10 days after intervention completion]

    Gaze patterns, and specifically attention allocation to threat will be used as moderators for clinical outcome, as well as indicators of target engagement.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tel Aviv University Tel Aviv Israel

Sponsors and Collaborators

  • Tel Aviv University

Investigators

  • Principal Investigator: Yair Bar-Haim, PhD, Tel Aviv University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Yair Bar-Haim, Professor, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT05159037
Other Study ID Numbers:
  • TAUgcMRTbooster
First Posted:
Dec 15, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 22, 2022