StressNCT03289156
Strategies for Responding to Stress
A study testing Arousal Reappraisal and Exercise in people with Stress, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Arousal Reappraisal and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.
Read the 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.
- Conditions
- Stress
- Being tested
- Arousal Reappraisal, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arousal ReappraisalBehavioural
Brief readings educating about the stress response and usefulness of arousal reappraisal.
ExerciseBehavioural
Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
| Study group | Role | What they receive |
|---|---|---|
| Arousal Reappraisal | Active comparator | Brief educational intervention about the stress response and arousal reappraisal Receives: Behavioral: Arousal Reappraisal |
| Exercise | Active comparator | Three 5-minute bouts of aerobic exercise at increasing intensities Receives: 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. Receives: Behavioral: Arousal Reappraisal; Behavioral: Exercise |
| Control | No intervention | Time-matched rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Reappraisal
Self-report ratings of appraisal of a lab based stressor as threatening or challenging.
Measured: One day
Secondary outcomes (2)
Psychological Response to Stress
Self-report ratings of perceived stress, anxiety, and fear in response to a lab based psychosocial stressor.
Measured: One day
Physiological Response to Stress
Heart rate in response to a lab based psychosocial stressor as threatening or challenging.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start18 Sep 2017
- Primary completion30 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolene Jacquart, University of Texas at Austin
- Investigators
- Jolene Jacquart, MA, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289156
- Sponsor's protocol ID
- 2017-05-0011
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Responding to Stress
- ClinicalTrials.gov ID
- NCT03289156
- Acronym / sponsor ID
- 2017-05-0011
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arousal Reappraisal | Active comparator | Behavioral: Arousal ReappraisalBrief educational intervention about the stress response and arousal reappraisal |
| Exercise | Active comparator | Behavioral: ExerciseThree 5-minute bouts of aerobic exercise at increasing intensities |
| Arousal Reappraisal + Exercise | Experimental | Behavioral: Arousal Reappraisal, Behavioral: ExerciseBrief 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. |
| Control | No intervention | –Time-matched rest |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arousal ReappraisalBrief readings educating about the stress response and usefulness of arousal reappraisal. | Behavioural | Arousal Reappraisal, Arousal Reappraisal + Exercise |
| ExerciseThree 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery. | Behavioural | Arousal Reappraisal + Exercise, Exercise |
Primary outcome
Stress Reappraisal
Time frame: One day
Self-report ratings of appraisal of a lab based stressor as threatening or challenging.
2 secondary outcomes
Psychological Response to Stress
Time frame: One day
Physiological Response to Stress
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolene Jacquart, MA principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arousal Reappraisal and Exercise in people with Stress, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Reappraisal (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.