Acceptance and Mindfulness for Exercise in Anxiety

NCT03818789 | Terminated

• 1 other identifier: 2016-11-0091
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory

  One week follow-up

• Depression symptoms: Beck Depression Inventory

  One week follow-up

• Mindfulness during exercise: State Mindfulness Scale for Physical Activity

  Assessed in the lab (day 1 of participation) and at follow-ups one week later

Study Arms (2)

Mindfulness

EXPERIMENTAL

A mindfulness training is applied to see if it supports exercise endurance in-lab and during follow-up

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.

Behavioral: Study skills video

Interventions

Mindfulness and acceptance training BEHAVIORAL

A breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress

Mindfulness

Study skills video BEHAVIORAL

A YouTube video describing study skills and suggested habits is used as a control condition.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

College of Liberal Arts

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: January 28, 2019
• Study Start: February 23, 2017
• Primary Completion: March 15, 2020
• Study Completion: September 1, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)