NCT06086756

Brief Summary

Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

October 2, 2023

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Public Speaking Anxiety

    Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

    Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen

Secondary Outcomes (3)

  • Valence

    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure

  • Social Phobia

    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure

  • Public Speaking Anxiety

    Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure

Study Arms (2)

Positive Mood Induction via positive film clips

EXPERIMENTAL

The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit positive affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes.

Behavioral: Exposure intervention plus positive mood induction

Negative Mood Induction via negative film clips

EXPERIMENTAL

The standardized procedures outlined in our laboratory's previously conducted study (Stathopoulou, Pollack, \& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit negative affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don't try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \& Otto, 2018). Together, the two film clips will last for approximately 5 minutes.

Behavioral: Exposure intervention plus negative mood induction

Interventions

Positive mood induction followed by a brief VR exposure session for public speaking anxiety.

Positive Mood Induction via positive film clips

Negative mood induction followed by a brief VR exposure session for public speaking anxiety.

Negative Mood Induction via negative film clips

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-report of 18 years of age or older
  • Current student at Boston University
  • Ability to read English to provide informed consent
  • Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
  • For Phase 2: speech anxiety scale score of ≥ 14 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

You may not qualify if:

  • Previous participation (i.e., no participant may take the survey more than once).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Anxiety and Related Disorders

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

SpeechGlossophobia

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Study Officials

  • Elias Culver

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 17, 2023

Study Start

November 1, 2023

Primary Completion

December 5, 2023

Study Completion

December 5, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations