NCT03128437

Brief Summary

This is a randomized control trial to test the effect of an anxiety sensitivity intervention on health behaviors among 18-35 year-olds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2.4 years

First QC Date

April 20, 2017

Last Update Submit

November 22, 2019

Conditions

Anxiety Sensitivity

Keywords

AnxietyYoung AdultsHealth Behaviors

Outcome Measures

Primary Outcomes (1)

  • Anxiety sensitivity

    Anxiety sensitivity represents an individual-level propensity to appraise the experience of anxiety as aversive in terms of social, physical, and/or cognitive consequences. It has been implicated in the maintenance of fear behavior (i.e., avoidance) and the development of clinically significant symptomatology with respect to anxiety and depression. Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3.

    4 weeks

Secondary Outcomes (7)

  • Physical activity

    4 & 8 weeks

  • Anxiety sensitivity

    8 weeks

  • Heart rate variability

    2 weeks

  • Alcohol use

    4 & 8 weeks

  • Binge eating

    4 & 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Aerobic Exercise Condition

EXPERIMENTAL

6 aerobic exercise exposures will be completed over the course of 2 weeks.

Behavioral: Aerobic Exercise

Assessment Only Condition

NO INTERVENTION

Participants randomly assigned to the control condition will complete assessments at the same time intervals as the active condition, but will not participate in exercise sessions. Assessments will take place at baseline, week 2, week 4, and week 8.

Interventions

Aerobic ExerciseBEHAVIORAL

At each of the six exposure sessions, participants will be invited to engage in 2-minute warm-up on the treadmill. Following this warm-up period, participants will be asked to briskly walk or jog on the treadmill at a speed that maintains their heart rate at 60-80% of maximum age-predicted heart rate for 20 minutes using the formula: (220-age) x (0.60 \[lower bound\] or 0.80 \[upper bound\]). Participants will be fitted with a heart rate monitor, which will be checked by a research assistant at 5-minute intervals in order to ensure adherence to this prescription; participants will be asked to adjust treadmill speed in order to remain in this range. Following each 20-minute exposure, participants will complete 5 minutes of cool down walking on the treadmill. Assessments will take place at baseline, week 2 (post-intervention), week 4, and week 8.

Aerobic Exercise Condition

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-35
  • Elevated anxiety sensitivity (ASI-3 score \>=23)
  • Able to safely participate in moderate-intensity physical activity as assessed by the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during screening

You may not qualify if:

  • Current aerobic exercise routine - Measured using the L-CAT with an established cut point of \>2 (assessed at screening)
  • Receiving ongoing psychotherapy or counseling (Self-report at screening)
  • Recent change in psychotropic medication for anxiety (Self-report at screening)
  • Psychiatric hospitalization in past 6 months (Self-report at screening)
  • Current pregnancy (Self-report at screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University, School of Medicine

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Lanoye A, Rybarczyk B, Evans R, Leahey T, LaRose J. Pilot randomized clinical trial targeting anxiety sensitivity: effects on physical activity. Cogn Behav Ther. 2022 May;51(3):257-271. doi: 10.1080/16506073.2021.1954082. Epub 2021 Aug 10.

    PMID: 34374633DERIVED

MeSH Terms

Conditions

Anxiety DisordersHealth Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jessica LaRose, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

May 9, 2017

Primary Completion

October 7, 2019

Study Completion

October 7, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)