Anxiety, Mood, and Health Behaviors in Young Adults

NCT ID: NCT03128437

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2019-10-07

Brief Summary

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

Detailed Description

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This is a 2-arm randomized control trial to test the effect of an anxiety sensitivity intervention on health behaviors among 18-35 year-olds. Participants will be 18-35 year-olds with high anxiety sensitivity randomized to 1)Exercise Exposure Intervention or 2)Assessment Only Control Condition. Participants in both groups will be followed for 8 weeks.

Conditions

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Anxiety Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise Condition

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

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.

Assessment Only Condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica LaRose, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University, School of Medicine

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34374633 (View on PubMed)

Other Identifiers

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HM20009285

Identifier Type: -

Identifier Source: org_study_id

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