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Anxiety, Mood, and Health Behaviors in Young Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03128437
Enrollment
69
Registered
2017-04-25
Start date
2017-05-09
Completion date
2019-10-07
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Sensitivity

Keywords

Anxiety, Young Adults, Health Behaviors

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.

Interventions

BEHAVIORALAerobic 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.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Anxiety sensitivity4 weeksAnxiety 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

MeasureTime frameDescription
Anxiety sensitivity8 weeksAnxiety 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 variability2 weeksA 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 use4 & 8 weeksQuantity 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.
Physical activity4 & 8 weeksPhysical activity will be assessed using the 7-day Physical Activity Recall questionnaire.
Sleep4 & 8 weeksThe 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 Change4 & 8 WeeksStage 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.
Binge eating4 & 8 weeksConsistent 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026