- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03818789
Acceptance and Mindfulness for Exercise in Anxiety
July 19, 2021 updated by: Emily Carl, University of Texas at Austin
Mindfulness and Acceptance for Exercise in Anxiety
Anxiety is a common experience, with the U.S. lifetime prevalence of any anxiety disorder at 28.8%.
Exercise has shown large effect sizes relative to controls in reducing mood and anxiety symptoms.
An anxious population generally has more difficulty when beginning or increasing an exercise regimen, due to a higher level of sensitivity to discomfort.
Mindfulness practices may be helpful in improving adherence to an exercise program.
A similar study has shown that mindfulness may reduce perceived effort and make exercise more enjoyable.
Furthermore, mindfulness has been shown to be an effective intervention in reducing anxiety and physical discomfort.
The investigators intend to use a brief intervention incorporating strategies of mindfulness and Acceptance and Commitment Therapy (ACT) in conjunction with exercise to ease the transition into regular/increased physical exercise.
Measures of anxiety sensitivity and perceived stress will be included to measure whether they change, and their possible effect as moderating variables on exercise adherence.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- 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
-
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Texas
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Austin, Texas, United States, 78712
- College of Liberal Arts
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students who are enrolled in Psychology 301 at the University of Texas at Austin, as well as adult and student volunteers recruited from the University of Texas at Austin campus and the greater Austin community, who are 18-65 will be eligible for this study.
- Participants must exercise less than 150 minutes per week doing moderate-intensity exercise consistently within the last two months.
- They will have at least mild anxiety, as measured with either a minimum score of 8 on the Beck Anxiety Inventory, or 5 on the Generalized Anxiety Disorder-7.
Exclusion Criteria:
- Those that are at moderate or high risk based on the pre-participation exercise health screening by the American College of Sports Medicine, or any participants that have been advised to not participate in exercise or aerobic activity by a qualified medical provider.
- Those with cardiovascular or pulmonary diseases, immunological diseases, neurological disorders, or have serious bone or joint problems.
- The Beck Depression Inventory's item on suicidality will be actively checked for a response of 2 or 3, with further screening given to those participants using questions from the C-SSRS to screen for current suicidal ideation and past suicidal behavior. Participants who endorse imminent intent or a plan to act on suicidal thoughts will be immediately referred to one of the IMHR's psychologists, or 911 will be contacted if they are at immediate risk of suicidal self-harm. Participants endorsing intent or a specific plan will not be included in the study. Participants expressing suicidal thoughts without imminent intent or a specific plan will be given resources to pursue mental health treatment.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
A mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up
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A breathing mediation, body scan, talking about acceptance, and presence activity are used.
All are low-impact and expected to cause no distress
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Placebo Comparator: Control
A study skills video is shown intended to have no effect on exercise but to match for time.
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A YouTube video describing study skills and suggested habits is used as a control condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of time run in minutes
Time Frame: During lab visit (day 1 of participation)
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The voluntary decision when to stop exercising on the treadmill in the lab
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During lab visit (day 1 of participation)
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Amount of time in minutes of vigorous and moderate exercise in following week
Time Frame: One week follow-up
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Amount exercised as assessed by International Physical Activity Questionnaire at follow-up
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One week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory
Time Frame: One week follow-up
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These self-report questionnaires assess general anxiety symptoms
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One week follow-up
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Depression symptoms: Beck Depression Inventory
Time Frame: One week follow-up
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This self-report questionnaire assesses depression symptoms
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One week follow-up
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Mindfulness during exercise: State Mindfulness Scale for Physical Activity
Time Frame: Assessed in the lab (day 1 of participation) and at follow-ups one week later
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This self-report questionnaire is designed to assess mindful state specifically during exercise
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Assessed in the lab (day 1 of participation) and at follow-ups one week later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 23, 2017
Primary Completion (Actual)
March 15, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
January 24, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-11-0091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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