TU Tough: Mental Toughness Training for College Success

NCT02982070 | Completed

• 1 other identifier: 2016-004
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Stress, Psychological

Keywords

psychological well-being, academic success

Outcome Measures

Primary Outcomes (5)

• Grade point average (GPA)

  GPA obtained from academic records

  Last semester that students are enrolled at the university, on average after 3.5 years.

• Retention in college

  Retention assessed as whether or not the student remains enrolled in the university.

  Last semester that students are enrolled at the university, on average after 3.5 years.

• Change in Connor---Davidson Resilience Scale (CD---RISC 10)

  This measure assessed characteristics associated with resiliency and mental toughness.

  Baseline and completion of training, on average after 4 weeks.

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  This measure assesses symptoms of anxiety over the past 7 days.

  Baseline and completion of training, on average after 4 weeks.

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale

  This measure assesses symptoms of depression.

  Baseline and completion of training, on average after 4 weeks.

Secondary Outcomes (5)

• National Institute of Health Toolbox Perceived Stress Scale

  Average across all time points from post-training (average of 4 weeks after baseline) to the last semester they are enrolled at the university, (on average 3.5 years after baseline).

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  Average across all time points from post-training (average of 4 weeks after baseline) to the last semester they are enrolled at the university, (on average 3.5 years after baseline).

• Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale

  Average across all time points from post-training (average of 4 weeks after baseline) to the last semester they are enrolled at the university, (on average 3.5 years after baseline).

• Change in percent signal change within anatomically-defined medial prefrontal cortex, amygdala, dorsolateral prefrontal cortex, anterior insula, and ventral striatum.

  Baseline and completion of training, on average after 4 weeks.

• Resting state connectivity between brain regions

  Baseline and completion of training, on average after 4 weeks.

Study Arms (2)

Mental Toughness Training

EXPERIMENTAL

Behavioral training in goal-building, mindfulness, and the growth mindset.

Behavioral: Mental Toughness Training

College as Usual

NO INTERVENTION

no training provided

Interventions

Mental Toughness Training BEHAVIORAL

Behavioral training in goal-building, mindfulness, and the growth mindset.

Also known as: Resiliency training

Mental Toughness Training

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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)
• Non-correctable vision or hearing problems

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (2)

The University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Robin Aupperle, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 5, 2016
• Study Start: September 1, 2016
• Primary Completion: March 18, 2023
• Study Completion: July 23, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)