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NCT Number: NCT03128437

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.

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Key information

Conditions

Anxiety Sensitivity Anxiety Disorders Behavior Health Behavior Mental Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University, School of Medicine

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aerobic Exercise

Behavioral

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 outcomes

  1. Anxiety sensitivity

    Time frame: 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 outcomes

  1. Physical activity

    Time frame: 4 & 8 weeks

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

  2. Anxiety sensitivity

    Time frame: 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.

  3. Heart rate variability

    Time frame: 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.

  4. Alcohol use

    Time frame: 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.

  5. Binge eating

    Time frame: 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.

  6. Sleep

    Time frame: 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.

  7. Exercise Stage of Change

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2017
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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