Acceptance and Mindfulness for Exercise in Anxiety

Anxiety Clinical Trial

Official title:

Mindfulness and Acceptance for Exercise in Anxiety

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03818789
• Other study ID #: 2016-11-0091
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: September 1, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Mindfulness and acceptance training
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 video
A YouTube video describing study skills and suggested habits is used as a control condition.

Locations

Country	Name	City	State
United States	College of Liberal Arts	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of time run in minutes	The voluntary decision when to stop exercising on the treadmill in the lab	During lab visit (day 1 of participation)
Primary	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	One week follow-up
Secondary	Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory	These self-report questionnaires assess general anxiety symptoms	One week follow-up
Secondary	Depression symptoms: Beck Depression Inventory	This self-report questionnaire assesses depression symptoms	One week follow-up
Secondary	Mindfulness during exercise: State Mindfulness Scale for Physical Activity	This self-report questionnaire is designed to assess mindful state specifically during exercise	Assessed in the lab (day 1 of participation) and at follow-ups one week later