NCT03289156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

September 18, 2017

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress Reappraisal

    Self-report ratings of appraisal of a lab based stressor as threatening or challenging.

    One day

Secondary Outcomes (2)

  • Psychological Response to Stress

    One day

  • Physiological Response to Stress

    One day

Study Arms (4)

Arousal Reappraisal

ACTIVE COMPARATOR

Brief educational intervention about the stress response and arousal reappraisal

Behavioral: Arousal Reappraisal

Exercise

ACTIVE COMPARATOR

Three 5-minute bouts of aerobic exercise at increasing intensities

Behavioral: Exercise

Arousal Reappraisal + Exercise

EXPERIMENTAL

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 ReappraisalBehavioral: Exercise

Control

NO INTERVENTION

Time-matched rest

Interventions

Brief readings educating about the stress response and usefulness of arousal reappraisal.

Arousal ReappraisalArousal Reappraisal + Exercise
ExerciseBEHAVIORAL

Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.

Arousal Reappraisal + ExerciseExercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jolene Jacquart, MA

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 20, 2017

Study Start

September 18, 2017

Primary Completion

March 30, 2019

Study Completion

May 30, 2019

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations