Clinical trial NCT03818789: Acceptance and Mindfulness for Exercise in Anxiety
Official title: Mindfulness and Acceptance for Exercise in Anxiety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount of time run in minutes
timeFrame: During lab visit (day 1 of participation)
measure: Amount of time in minutes of vigorous and moderate exercise in following week
timeFrame: One week follow-up
Secondary outcomes:
measure: Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory
timeFrame: One week follow-up
measure: Depression symptoms: Beck Depression Inventory
timeFrame: One week follow-up
measure: Mindfulness during exercise: State Mindfulness Scale for Physical Activity
timeFrame: Assessed in the lab (day 1 of participation) and at follow-ups one week later
Other outcomes:
Locations:
city: Austin
country: United States
facility: College of Liberal Arts
state: Texas
Study officials:
References: