TU Tough: Mental Toughness Training for College Success (NCT02982070) | Clinical Trial Compass
CompletedNot Applicable
TU Tough: Mental Toughness Training for College Success
United States538 participantsStarted 2016-09
Plain-language summary
The aims of this study are to (1) assess the extent of psychological distress for incoming first-year students at the University of Tulsa (Part 1), (2) assess the impact of "mental toughness" training on the trajectory of psychological well-being and academic success (Part 2), (3) assess the impact of mental toughness training on neural and behavioral reactivity to affective stimuli and decisions (Part 3), and (4) examine genetic markers of resiliency in college populations and interactions between genetic markers and response to mental toughness training (Part 2).
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 17 years old and over as of the first day of classes at TU for the year they are being enrolled in the study. Due to this, all participants will be 18 years of age or older when completing Year 2 of the longitudinal aspect of the study (Part 2, Component B and C). A separate section concerning the inclusion of minors has been included below.
. Are an incoming first year student at the University of Tulsa
. All genders
. All races
. Able to provide informed consent (or, if 17, to have their parents complete informed consent and the minor complete informed assent).
. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grade point average (GPA)
Timeframe: Last semester that students are enrolled at the university, on average after 3.5 years.
2
Retention in college
Timeframe: Last semester that students are enrolled at the university, on average after 3.5 years.
3
Change in Connor---Davidson Resilience Scale (CD---RISC 10)
Timeframe: Baseline and completion of training, on average after 4 weeks.
4
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Timeframe: Baseline and completion of training, on average after 4 weeks.
5
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Timeframe: Baseline and completion of training, on average after 4 weeks.
Trial details
NCT IDNCT02982070
SponsorLaureate Institute for Brain Research, Inc.
. Have regular access to a personal, campus, or other computer on which to complete online surveys.
. For Part 3 only (neuroimaging portion), participants must have at least normative levels of perceived stress (\>21), as determined by the mean score from the initial survey session completed under protocol 2015-010. This is to identify participants who have the greatest potential to show demonstrable symptomatic change with mental toughness training.
Exclusion criteria
. Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
. Current use of a medication that could potentially affect brain functioning (e.g., stimulants, antidepressants, anxiolytics, antipsychotics, mood stabilizers, anti-hypertensives). Inclusion of individuals reporting other types of medications or supplements not listed or considered thus far will be at the discretion of the PI according to evidence in the literature of it affecting brain function or brain blood flow.
. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy.
. Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider)