- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289156
Strategies for Responding to Stress
November 4, 2020 updated by: Jolene Jacquart, University of Texas at Austin
The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.
Different strategies being examined in this study include exercise and arousal reappraisal.
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females ages 18 to 35
- Speaks English fluently
- Passes the Physical Activity Readiness Questionnaire-Plus
- Mild to Moderate depression symptoms as measured by the Beck Depression Inventory-II (a score ≥14 but ≤25)
Exclusion Criteria:
- Hearing or visually impaired such that it will interfere with ability to participate effectively
- Currently exercising regularly, defined as exercising at a moderate-intensity more than 2 times a week, for at least 20 minutes each time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arousal Reappraisal
Brief educational intervention about the stress response and arousal reappraisal
|
Brief readings educating about the stress response and usefulness of arousal reappraisal.
|
|
Active Comparator: Exercise
Three 5-minute bouts of aerobic exercise at increasing intensities
|
Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
|
|
Experimental: Arousal Reappraisal + Exercise
Brief educational intervention about the stress response and arousal reappraisal followed by three 5-minute bouts of aerobic exercise at increasing intensities with practice applying the arousal reappraisal learned earlier.
|
Brief readings educating about the stress response and usefulness of arousal reappraisal.
Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
|
|
No Intervention: Control
Time-matched rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress Reappraisal
Time Frame: One day
|
Self-report ratings of appraisal of a lab based stressor as threatening or challenging.
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Response to Stress
Time Frame: One day
|
Self-report ratings of perceived stress, anxiety, and fear in response to a lab based psychosocial stressor.
|
One day
|
|
Physiological Response to Stress
Time Frame: One day
|
Heart rate in response to a lab based psychosocial stressor as threatening or challenging.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jolene Jacquart, MA, University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2017
Primary Completion (Actual)
March 30, 2019
Study Completion (Actual)
May 30, 2019
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
September 18, 2017
First Posted (Actual)
September 20, 2017
Study Record Updates
Last Update Posted (Actual)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2017-05-0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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