Anxiety, Mood, and Health Behaviors in Young Adults

Not Applicable

Completed

• Conditions: Anxiety Sensitivity
• Interventions: Behavioral: Aerobic Exercise

• Registration Number: NCT03128437
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Study Start: 2017-05-09
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Condition	Aerobic Exercise	6 aerobic exercise exposures will be completed over the course of 2 weeks.

Primary Outcome Measures

Name	Time	Method
Anxiety sensitivity	4 weeks	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

Name	Time	Method
Physical activity	4 & 8 weeks	Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.
Heart rate variability	2 weeks	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.
Sleep	4 & 8 weeks	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	4 & 8 Weeks	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."
Anxiety sensitivity	8 weeks	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.
Binge eating	4 & 8 weeks	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.
Alcohol use	4 & 8 weeks	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.

Trial Locations

Locations (1)

Virginia Commonwealth University, School of Medicine; 🇺🇸 Richmond, Virginia, United States