Anxiety, Mood, and Health Behaviors in Young Adults

Anxiety Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128437
• Other study ID #: HM20009285
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: October 7, 2019

Study information

• Verified date: November 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Sensitivity

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University, School of Medicine	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical activity	Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.	4 & 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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