NCT06468878

Brief Summary

Exposure-based cognitive behavior therapy is an efficacious treatment for acrophobia (fear of heights) and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate the effects of liked, non-lyrical background music on the efficacy of a brief VR exposure intervention.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 8, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

June 16, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acrophobia (Fear of Heights)

    Assessed using the Acrophobia Questionnaire (AQ) Anxiety Subscale

    Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure

Secondary Outcomes (2)

  • Valance

    Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure

  • Height-Relevant Interpretations

    Comparison of pre-exposure scores to scores from the follow-up survey one week after exposure

Study Arms (2)

Exposure Intervention with Non-Lyrical, Liked Background Music

EXPERIMENTAL

Participants will be presented with a list of instrumental songs without lyrics from popular movies. Participants will then rank the songs in order of those they would like to hear the most. During VR heights exposure the participants' highest-ranked songs will be played in the background at a low volume.

Behavioral: Exposure Intervention Plus Music Induction

Exposure Intervention without Background Music

EXPERIMENTAL

Participants will undergo VR heights exposure without background music.

Behavioral: Exposure Intervention With No Music Induction

Interventions

VR exposure for acrophobia with background music.

Exposure Intervention with Non-Lyrical, Liked Background Music

VR exposure for acrophobia with no background music.

Exposure Intervention without Background Music

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: Acrophobia score of ≥ 45.45 on the Acrophobia Questionnaire (AQ) Anxiety Subscale

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)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Acrophobia

Study Officials

  • Laura Long, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura J Long, PhD

CONTACT

Michael Otto, PhD

CONTACT

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

June 16, 2024

First Posted

June 21, 2024

Study Start

July 8, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations