NCT02361203

Brief Summary

The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

January 29, 2015

Last Update Submit

February 1, 2016

Conditions

Fear of Heights

Outcome Measures

Primary Outcomes (2)

  • Fear scores

    Change in fear scores using subjective units of distress will be assessed.

    7 (+/- 3) days after exposure therapy

  • Perceived threat likelihood scores

    Change in the perception of threat likelihood on a scale from 1-5 will be assessed.

    7 (+/- 3) days after exposure therapy

Secondary Outcomes (5)

  • Skin conductance fluctuations

    7 (+/- 3) days after exposure therapy

  • Heart rate fluctuations

    7 (+/- 3) days after exposure therapy

  • Acrophobia Severity

    14 (+/- 3) days after exposure therapy

  • Attitudes Toward Heights

    14 (+/- 3) days after exposure therapy

  • Clinical Global Improvement

    14 (+/- 3) days after exposure therapy

Study Arms (2)

No Exercise

NO INTERVENTION

Exercise Pre

EXPERIMENTAL

30 minutes of aerobic exercise before exposure therapy

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.

Exercise Pre

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 25
  • Speaks English fluently
  • Score of 80 or higher on the Acrophobia Questionnaire
  • SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear
  • Passes the Physical Activity Readiness Questionnaire-Plus

You may not qualify if:

  • Hearing or visually impaired
  • Currently receiving exposure-based treatment for acrophobia
  • Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating \< 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Acrophobia

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jasper Smits, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 11, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

US(1)