AnxietyNCT03818789
Acceptance and Mindfulness for Exercise in Anxiety
A study testing Mindfulness and acceptance training and Study skills video in people with Anxiety, run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Mindfulness and acceptance training and Study skills video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 1 Sep 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety
- Being tested
- Mindfulness and acceptance training, Study skills video
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and acceptance trainingBehavioural
A breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress
Study skills videoBehavioural
A YouTube video describing study skills and suggested habits is used as a control condition.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | A mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up Receives: Behavioral: Mindfulness and acceptance training |
| Control | Placebo comparator | A study skills video is shown intended to have no effect on exercise but to match for time. Receives: Behavioral: Study skills video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time run in minutes
The voluntary decision when to stop exercising on the treadmill in the lab
Measured: During lab visit (day 1 of participation)
Amount of time in minutes of vigorous and moderate exercise in following week
Amount exercised as assessed by International Physical Activity Questionnaire at follow-up
Measured: One week follow-up
Secondary outcomes (3)
Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory
These self-report questionnaires assess general anxiety symptoms
Measured: One week follow-up
Depression symptoms: Beck Depression Inventory
This self-report questionnaire assesses depression symptoms
Measured: One week follow-up
Mindfulness during exercise: State Mindfulness Scale for Physical Activity
This self-report questionnaire is designed to assess mindful state specifically during exercise
Measured: Assessed in the lab (day 1 of participation) and at follow-ups one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start23 Feb 2017
- Primary completion15 Mar 2020
- Study completion1 Sep 2020
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Carl, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818789
- Sponsor's protocol ID
- 2016-11-0091
- Status last verified
- Jul 2021
- First submitted
- 31 Oct 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Acceptance for Exercise in Anxiety
- ClinicalTrials.gov ID
- NCT03818789
- Acronym / sponsor ID
- 2016-11-0091
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness and acceptance trainingA mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up |
| Control | Placebo comparator | Behavioral: Study skills videoA study skills video is shown intended to have no effect on exercise but to match for time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and acceptance trainingA breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress | Behavioural | Mindfulness |
| Study skills videoA YouTube video describing study skills and suggested habits is used as a control condition. | Behavioural | Control |
Primary outcome
Amount of time run in minutes
Time frame: During lab visit (day 1 of participation)
The voluntary decision when to stop exercising on the treadmill in the lab
Amount of time in minutes of vigorous and moderate exercise in following week
Time frame: One week follow-up
Amount exercised as assessed by International Physical Activity Questionnaire at follow-up
3 secondary outcomes
Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory
Time frame: One week follow-up
Depression symptoms: Beck Depression Inventory
Time frame: One week follow-up
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
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and acceptance training and Study skills video in people with Anxiety, run by University of Texas at Austin 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 3 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: stopped early, as of the sponsor's last update on 22 Jul 2021. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: COVID). Results are not available in the source record.
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?
Amount of time run in minutes (time frame: During lab visit (day 1 of participation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021.