Anxiety, Mood, and Health Behaviors in Young Adults

The Relationship Between Anxiety, Mood, and Health Behaviors in Young Adults

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

Study Overview

• Status: Completed
• Conditions: Anxiety Sensitivity
• Intervention / Treatment: Behavioral: Aerobic Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise Condition; 6 aerobic exercise exposures will be completed over the course of 2 weeks.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.	4 & 8 weeks
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.	8 weeks
Heart rate variability	A continuous 3 lead ECG (SE-1010 PC ECG, Edan USA) will be acquired for 5 minutes while the subject rests in a supine position in a quiet, private room.	2 weeks
Alcohol use	Quantity and frequency of alcohol use will be assessed using the Timeline Follow-back method (Alcohol TLFB; Sobell & Sobell, 1992). This semi-structured interview asks participants to retrace their behavior and activities over a given timespan in order to assess daily alcohol use.	4 & 8 weeks
Binge eating	Consistent with methods reported in Deboer et al., (2012), binge eating frequency will be assessed continuously using item 8 of the Eating Disorder Diagnostic Scale (EDDS; Stice, Telch, & Rizvi, 2000): "How many times have you eaten an unusually large amount of food and experienced a loss of control?" This question will be integrated into the semi-structured interview procedures as described above in order to increase accuracy of responses.	4 & 8 weeks
Sleep	The Insomnia Severity Index (ISI; Bastien, Vallieres, & Morin, 2001) will also be administered in order to capture more nuanced information about participants' sleep quality. Seven items assessing severity of insomnia symptoms comprise the ISI, with higher scores indicating more significant sleep disturbances.	4 & 8 weeks
Exercise Stage of Change	Stage of exercise behavior change will be measured using a 6-item self-report questionnaire developed by Marcus, Selby, Niaura, & Rossi (1992). Participants respond to each item using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree."	4 & 8 Weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jessica LaRose, PhD, Virginia Commonwealth University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Young Adults; Health Behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: HM20009285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No