- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05159037
Using the Musical Track From GC-MRT as a Treatment Booster in Stressful Situations
June 20, 2022 updated by: Yair Bar-Haim, Tel Aviv University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel
- Tel Aviv University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
Feedback according to participants' viewing patterns, in order to modify their attention.
Participants listen to a musical track they ranked as highly liked before a stressful situation
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|
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.
|
Feedback according to participants' viewing patterns, in order to modify their attention.
Participants listen to a musical track they ranked as highly liked before a stressful situation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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2 days before intervention, 4-10 days after intervention completion
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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).
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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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSPS (Public Speaking Performance Scale)
Time Frame: 4-10 days after intervention completion (During speech task)
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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.
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4-10 days after intervention completion (During speech task)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline - viewing patterns on threat-neutral face matrices
Time Frame: 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.
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At the first day of intervention, 4-10 days after intervention completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 7, 2021
Primary Completion (ACTUAL)
June 20, 2022
Study Completion (ACTUAL)
June 20, 2022
Study Registration Dates
First Submitted
November 15, 2021
First Submitted That Met QC Criteria
December 1, 2021
First Posted (ACTUAL)
December 15, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 20, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- TAUgcMRTbooster
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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