Acceptance and Mindfulness for Exercise in Anxiety

Sponsor
University of Texas at Austin (Other)
Overall Status
Terminated
CT.gov ID
NCT03818789
Collaborator
(none)
64
1
2
42.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness and acceptance training
  • Behavioral: Study skills video
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Mindfulness and Acceptance for Exercise in Anxiety
Actual Study Start Date :
Feb 23, 2017
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness

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

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

Placebo Comparator: Control

A study skills video is shown intended to have no effect on exercise but to match for time.

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

Outcome Measures

Primary Outcome Measures

  1. Amount of time run in minutes [During lab visit (day 1 of participation)]

    The voluntary decision when to stop exercising on the treadmill in the lab

  2. Amount of time in minutes of vigorous and moderate exercise in following week [One week follow-up]

    Amount exercised as assessed by International Physical Activity Questionnaire at follow-up

Secondary Outcome Measures

  1. Anxiety symptoms: Generalized Anxiety Disorder - 7 Scale, Beck Anxiety Inventory [One week follow-up]

    These self-report questionnaires assess general anxiety symptoms

  2. Depression symptoms: Beck Depression Inventory [One week follow-up]

    This self-report questionnaire assesses depression symptoms

  3. Mindfulness during exercise: State Mindfulness Scale for Physical Activity [Assessed in the lab (day 1 of participation) and at follow-ups one week later]

    This self-report questionnaire is designed to assess mindful state specifically during exercise

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 College of Liberal Arts Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Carl, Principal Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT03818789
Other Study ID Numbers:
  • 2016-11-0091
First Posted:
Jan 28, 2019
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2021