ClinicalTrials.gov
ClinicalTrials.gov Menu

Strategies for Responding to Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03289156
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jolene Jacquart, University of Texas at Austin

Brief Summary:
The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Arousal Reappraisal Behavioral: Exercise Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Strategies for Responding to Stress
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

Arm Intervention/treatment
Active Comparator: Arousal Reappraisal
Brief educational intervention about the stress response and arousal reappraisal
Behavioral: 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
Behavioral: Exercise
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.
Behavioral: Arousal Reappraisal
Brief readings educating about the stress response and usefulness of arousal reappraisal.

Behavioral: Exercise
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



Primary Outcome Measures :
  1. Stress Reappraisal [ Time Frame: One day ]
    Self-report ratings of appraisal of a lab based stressor as threatening or challenging.


Secondary Outcome Measures :
  1. 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.

  2. Physiological Response to Stress [ Time Frame: One day ]
    Heart rate in response to a lab based psychosocial stressor as threatening or challenging.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • A diagnoses of a condition that is known to influence hormone responses to stressors, specifically a diagnosis (based on self-report) of any of the following: breast/ovarian cancer, chronic pain, compromised immune system (e.g., HIV), diabetes, gastrointestinal disease, heart disease, herpes virus, high blood pressure, high cholesterol, infection/fever in the last 7 days, kidney disease, liver disease (e.g., hepatitis), migraines/chronic headaches, obstructive sleep apnea, respiratory disease (e.g., asthma), skeletal muscle disease, surgeries within the last 6 weeks suspected/diagnosed prostate cancer, thyroid disease, tuberculosis/history of positive tuberculosis test.
  • Current use of medications (based on self-report) that influence hormone responses to stressors, specifically any of the following drugs: acarbose, albiglutide, alogliptin, butalbital, canagliflozin, chlorpropamide, cyclosporine, cortisone, dapagliflozin, dexamethasone, dulaglutide, empagliflozin, exenatide, glimepiride, glipizide, glyburide, hydrocortisone, insulin, linagliptin, metformin, methylprednisone, miglitol, nateglinides, pentobarbital, phenobarbital, pioglitazone, pramlintide, prednisolone, prednisone, repaglinide, rosiglitazone, saxagliptin, secobarbital, sitagliptin, tacrolimus, tolazamide, tolbutamide, tolvaptan, warfarin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289156


Contacts
Contact: Jolene Jacquart, MA 512-655-9718 jolene.jacquart@utexas.edu

Locations
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Jolene Jacquart, MA    512-655-9718    jolene.jacquart@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Jolene Jacquart, MA University of Texas at Austin

Responsible Party: Jolene Jacquart, Graduate Student, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03289156     History of Changes
Other Study ID Numbers: 2017-05-0011
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No