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Acceptance and Mindfulness for Exercise in Anxiety

Primary Purpose

Anxiety

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness and acceptance training

Study skills video

About this trial

This is an interventional basic science trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

College of Liberal Arts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mindfulness

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Amount of time run in minutes

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

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

Secondary Outcome Measures

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

These self-report questionnaires assess general anxiety symptoms

Depression symptoms: Beck Depression Inventory

This self-report questionnaire assesses depression symptoms

Mindfulness during exercise: State Mindfulness Scale for Physical Activity

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

Full Information

NCT ID

NCT03818789

First Posted

October 31, 2018

Last Updated

July 19, 2021

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT03818789

Brief Title

Acceptance and Mindfulness for Exercise in Anxiety

Official Title

Mindfulness and Acceptance for Exercise in Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID

Study Start Date

February 23, 2017 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness and acceptance training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Study skills video

Intervention Description

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

Primary Outcome Measure Information:

Title

Amount of time run in minutes

Description

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

Time Frame

During lab visit (day 1 of participation)

Title

Amount of time in minutes of vigorous and moderate exercise in following week

Description

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

Time Frame

One week follow-up

Secondary Outcome Measure Information:

Title

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

Description

These self-report questionnaires assess general anxiety symptoms

Time Frame

One week follow-up

Title

Depression symptoms: Beck Depression Inventory

Description

This self-report questionnaire assesses depression symptoms

Time Frame

One week follow-up

Title

Mindfulness during exercise: State Mindfulness Scale for Physical Activity

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

College of Liberal Arts

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Acceptance and Mindfulness for Exercise in Anxiety

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