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Anxiety, Mood, and Health Behaviors in Young Adults

Primary Purpose

Anxiety Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety Sensitivity focused on measuring Anxiety, Young Adults, Health Behaviors

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Virginia Commonwealth University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Exercise Condition

Assessment Only Condition

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical activity
Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.
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.
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.
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.
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.
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.
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."

Full Information

First Posted
April 20, 2017
Last Updated
November 22, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03128437
Brief Title
Anxiety, Mood, and Health Behaviors in Young Adults
Official Title
The Relationship Between Anxiety, Mood, and Health Behaviors in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity
Keywords
Anxiety, Young Adults, Health Behaviors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Condition
Arm Type
Experimental
Arm Description
6 aerobic exercise exposures will be completed over the course of 2 weeks.
Arm Title
Assessment Only Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety sensitivity
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.
Time Frame
4 & 8 weeks
Title
Anxiety sensitivity
Description
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.
Time Frame
8 weeks
Title
Heart rate variability
Description
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.
Time Frame
2 weeks
Title
Alcohol use
Description
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.
Time Frame
4 & 8 weeks
Title
Binge eating
Description
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.
Time Frame
4 & 8 weeks
Title
Sleep
Description
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.
Time Frame
4 & 8 weeks
Title
Exercise Stage of Change
Description
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."
Time Frame
4 & 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica LaRose, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University, School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34374633
Citation
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.
Results Reference
derived

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Anxiety, Mood, and Health Behaviors in Young Adults

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