Anxiety, Mood, and Health Behaviors in Young Adults

November 22, 2019 updated by: Virginia Commonwealth University

The Relationship Between 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic Exercise Condition
6 aerobic exercise exposures will be completed over the course of 2 weeks.
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.
No Intervention: Assessment Only Condition

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 4 & 8 weeks
Physical activity will be assessed using the 7-day Physical Activity Recall questionnaire.
4 & 8 weeks
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.
8 weeks
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.
2 weeks
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.
4 & 8 weeks
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.
4 & 8 weeks
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.
4 & 8 weeks
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."
4 & 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica LaRose, PhD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20009285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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