NCT03461016

Brief Summary

Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Technological advancements, as with smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic material on a smartphone might promote increased adherence in conducting self-directed exposure. Additionally, exposure can incorporate phobic material from different perspectives (i.e., first-person or third-person), which is one factor that may impact treatment effectiveness. Participants will be randomly assigned to a treatment or control condition, and complete a pre-assessment and then a post-assessment two weeks later. The assessment consists of a multimodal approach (e.g., self-report, physiological response, and overt behavior). Participants in the treatment condition will be instructed to watch a standard exposure video of a dental examination and prophylaxis three times daily for two weeks. One week of videos was shown in a first-person perspective and the same video will be shown in a third-person perspective for one week. The study can demonstrate the potential utility of smartphone-based self-directed exposure therapy for specific phobia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration 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

Study Start

First participant enrolled

April 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

February 16, 2018

Last Update Submit

May 22, 2020

Conditions

Keywords

SmartphonesExposure TherapyDental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in Dental Fear Survey (scale 20-item)

    Participant self-report of dental care-related fear and anxiety, range of 20-100

    Change from Baseline to 14 days

Secondary Outcomes (2)

  • Change in Subjective Units of Distress (scale 1-item)

    Change from Baseline to 14 days

  • Acceptability (scale 8-item)

    14 days

Other Outcomes (1)

  • Change in Behavioral Avoidance Task behavior

    Change from Baseline to 14 days

Study Arms (2)

Smartphone-Based Exposure Therapy

EXPERIMENTAL

Participants assigned to the Smartphone-Based Exposure Therapy group will receive two weeks of exposure therapy via their smartphone. Participants will have the opportunity to receive up to 50 minutes of exposure video intervention daily for the two weeks.

Behavioral: Exposure Therapy

Waitlist Control

NO INTERVENTION

Participants who have been randomly assigned to participate in the Waitlist Control group will not receive treatment; however, after the two weeks of no intervention, participants in this condition will be offered the same treatment as the treatment condition.

Interventions

"Exposure therapy is a form of behavior therapy that is widely used to treat anxiety disorders, including specific phobia. It involves systematic and repeated confrontation with a feared stimulus. It works by (a) implosive therapy, habituation, in which repeated exposure reduces anxiety over time by a process of extinction; (b) disconfirming fearful predictions; and (c) increasing feelings of self-efficacy and mastery. In vivo exposure \[is\] a type of exposure therapy, generally used for treating individuals with phobias, obsessive compulsive disorder, and other anxiety disorders, in which the client directly experiences anxiety-provoking situations or stimuli in real-world conditions." (VandenBos, 2015)

Smartphone-Based Exposure Therapy

Eligibility Criteria

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

You may qualify if:

  • fluency in the English language
  • being 18 years of age or older
  • own or have access to a smartphone
  • have an e-mail account

You may not qualify if:

  • Reporting a low level of discomfort with dental-related care (i.e., less than a rating of "somewhat" on a single-item dental fear question)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

  • VandenBos, G. R. (Ed.) (2015). APA dictionary of psychology. Washington, DC: American Psychological Association.

    BACKGROUND

MeSH Terms

Conditions

Phobic Disorders

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daneil W McNeil, PhD

    West Virginia 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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 9, 2018

Study Start

April 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations