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Anxiety SensitivityNCT03128437

Anxiety, Mood, and Health Behaviors in Young Adults

A study testing Aerobic Exercise in people with Anxiety Sensitivity, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety Sensitivity
What is being tested?
Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
9 May 2017to 7 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University, School of Medicine

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Aerobic Exercise
Keywords
Anxiety, Young Adults, Health Behaviors
Medical subject headings
Anxiety Disorders, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    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.

Study groups in NCT03128437
Study groupRoleWhat they receive
Aerobic Exercise ConditionExperimental6 aerobic exercise exposures will be completed over the course of 2 weeks.
Receives: Behavioral: Aerobic Exercise
Assessment Only ConditionNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks

Secondary outcomes (7)

  1. Physical activity

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

    Measured: 4 & 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 2 weeks

  4. 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.

    Measured: 4 & 8 weeks

  5. 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.

    Measured: 4 & 8 weeks

  6. 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.

    Measured: 4 & 8 weeks

  7. 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."

    Measured: 4 & 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start9 May 2017
  3. Primary completion7 Oct 2019
  4. Study completion7 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03128437
Sponsor's protocol ID
HM20009285
Status last verified
Nov 2019
First submitted
20 Apr 2017
Last updated
25 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lanoye A, Rybarczyk B, Evans R, Leahey T, LaRose J. Pilot randomized clinical trial targeting anxiety sensitivity: effects on physical activity. Cogn Behav Ther. 2022 May;51(3):257-271. doi: 10.1080/16506073.2021.1954082. Epub 2021 Aug 10.

    PubMed 34374633

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise in people with Anxiety Sensitivity, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03128437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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