Stress, PsychologicalTUtoughNCT02982070
TU Tough: Mental Toughness Training for College Success
A study testing Mental Toughness Training in people with Stress, Psychological, run by Laureate Institute for Brain Research, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Mental Toughness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 23 Jul 2023
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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)
- Non-correctable vision or hearing problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Tulsa
Tulsa, Oklahoma, 74104
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: TU (University of Tulsa) Tough: Mental Toughness Training for College Success
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).
Read the detailed description
Part 1 will consist of an online survey, sent by email. This email will be sent through the TU (University of Tulsa) Student Affairs office to all incoming freshman students and will also be sent by study personnel to students who indicate interest in the study through the other recruitment efforts (i.e., flyers on campus). This survey will also allow students to indicate whether or not they would be interested in being involved in future research regarding mental toughness and strategies for college success. The second aim will be accomplished via Part 2 of the study. Part 2 is the longitudinal portion that assesses students' well-being (i.e., happiness, distress, anxiety, satisfaction, etc.) and academic success (i.e., retention at TU, GPA, etc.) before and after completion of either mental toughness training or "college as usual". These participants will be selected from the group of participants who complete Part 1 and/or via ongoing courses within each college at the university (see recruitment section). Part 2 will enroll a maximum of 300 participants/year for the first 3 years, each of whom will then be asked to remain in the study for 5 years. These participants will be contacted via phone, text message, or email to determine whether they are interested and meet criteria. Those who meet criteria will be scheduled for an in-person session at TU (Part 2) to complete written informed consent, provide the saliva sample, obtain instructions regarding the completion of survey sessions and the training protocol. Those who enroll in this study will then be asked to complete survey sessions repeatedly over the next 5 years: (1) During the first semester, Part 2 participants will be asked to complete three survey sessions, one pre- and one post- training phase, and one during finals week. (2) During the Spring semester of the first year, each participant would complete three surveys (within the first two weeks; mid semester; and during finals week), followed by one survey mid-Summer. (3) For Years 2-5, survey sessions would occur once per semester (Fall, Spring, Summer), allowing examination of how training may impact longer-term trajectories of academic success and psychological well-being. Each online surveys will assess for psychological well-being, demographics and medical history, and academic activities. For those who provide consent for us to access limited information from academic records (as specified in the consent and in the research protocol section of this document), the information will be combined with the collected survey data. For Part 3, data will be collected from a subset of participants during two neuroimaging sessions at LIBR (Laureate Institute for Brain Research). The first neuroimaging session will be completed within one month of beginning the training phase (mental toughness or "college as usual") and the second will be completed within one month of the end of the training phase. Each neuroimaging session will last approximately 3-4 hours and will involve completion of self-report measures regarding current affective state, a behavioral measure of exploratory behavior, and a functional MRI session during which participants will complete tasks related to processing of emotional faces, emotional images, and reward. The fourth aim will also be accomplished via Part 2 of the study, which involves the collection of DNA saliva collection once during the first semester of their first year. Samples will be collected in-person at their first baseline session, after written informed consent is obtained. This data will be used to assess any genetic markers of resiliency that exist in college populations and to determine if there are genetic markers that interact with the impact of mental toughness training (i.e., if individuals with specific genetic markers do better or worse with training).
- Conditions
- Stress, Psychological
- Being tested
- Mental Toughness Training
- Keywords
- psychological well-being, academic success
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Toughness TrainingBehavioural
Also called Resiliency training
Behavioral training in goal-building, mindfulness, and the growth mindset.
| Study group | Role | What they receive |
|---|---|---|
| Mental Toughness Training | Experimental | Behavioral training in goal-building, mindfulness, and the growth mindset. Receives: Behavioral: Mental Toughness Training |
| College as Usual | No intervention | no training provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade point average (GPA)
GPA obtained from academic records
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and completion of training, on average after 4 weeks.
Secondary outcomes (5)
National Institute of Health Toolbox Perceived Stress Scale
This measure assesses the level of stress experienced over the past month.
Measured: 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
This measure assesses symptoms of anxiety over the past 7 days.
Measured: 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
This measure assesses symptoms of depression over the past 7 days.
Measured: 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.
Change in percent signal change within anatomically-defined medial prefrontal cortex and amygdala (during emotional face processing), dorsolateral prefrontal cortex and anterior insula (during decision-making), and ventral striatum (during reward processing).
Measured: Baseline and completion of training, on average after 4 weeks.
Resting state connectivity between brain regions
Resting state connectivity between brain regions
Measured: Baseline and completion of training, on average after 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion18 Mar 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Aupperle, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982070
- Sponsor's protocol ID
- 2016-004
- Acronym
- TUtough
- Status last verified
- Aug 2023
- First submitted
- 29 Nov 2016
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TU (University of Tulsa) Tough: Mental Toughness Training for College Success
- ClinicalTrials.gov ID
- NCT02982070
- Acronym / sponsor ID
- TUtough / 2016-004
- Conditions
- Stress, Psychological
- Keywords
- psychological well-being, academic success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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 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).
Detailed description
Part 1 will consist of an online survey, sent by email. This email will be sent through the TU (University of Tulsa) Student Affairs office to all incoming freshman students and will also be sent by study personnel to students who indicate interest in the study through the other recruitment efforts (i.e., flyers on campus). This survey will also allow students to indicate whether or not they would be interested in being involved in future research regarding mental toughness and strategies for college success. The second aim will be accomplished via Part 2 of the study. Part 2 is the longitudinal portion that assesses students' well-being (i.e., happiness, distress, anxiety, satisfaction, etc.) and academic success (i.e., retention at TU, GPA, etc.) before and after completion of either mental toughness training or "college as usual". These participants will be selected from the group of participants who complete Part 1 and/or via ongoing courses within each college at the university (see recruitment section). Part 2 will enroll a maximum of 300 participants/year for the first 3 years, each of whom will then be asked to remain in the study for 5 years. These participants will be contacted via phone, text message, or email to determine whether they are interested and meet criteria. Those who meet criteria will be scheduled for an in-person session at TU (Part 2) to complete written informed consent, provide the saliva sample, obtain instructions regarding the completion of survey sessions and the training protocol. Those who enroll in this study will then be asked to complete survey sessions repeatedly over the next 5 years: (1) During the first semester, Part 2 participants will be asked to complete three survey sessions, one pre- and one post- training phase, and one during finals week. (2) During the Spring semester of the first year, each participant would complete three surveys (within the first two weeks; mid semester; and during finals week), followed by one survey mid-Summer. (3) For Years 2-5, survey sessions would occur once per semester (Fall, Spring, Summer), allowing examination of how training may impact longer-term trajectories of academic success and psychological well-being. Each online surveys will assess for psychological well-being, demographics and medical history, and academic activities. For those who provide consent for us to access limited information from academic records (as specified in the consent and in the research protocol section of this document), the information will be combined with the collected survey data. For Part 3, data will be collected from a subset of participants during two neuroimaging sessions at LIBR (Laureate Institute for Brain Research). The first neuroimaging session will be completed within one month of beginning the training phase (mental toughness or "college as usual") and the second will be completed within one month of the end of the training phase. Each neuroimaging session will last approximately 3-4 hours and will involve completion of self-report measures regarding current affective state, a behavioral measure of exploratory behavior, and a functional MRI session during which participants will complete tasks related to processing of emotional faces, emotional images, and reward. The fourth aim will also be accomplished via Part 2 of the study, which involves the collection of DNA saliva collection once during the first semester of their first year. Samples will be collected in-person at their first baseline session, after written informed consent is obtained. This data will be used to assess any genetic markers of resiliency that exist in college populations and to determine if there are genetic markers that interact with the impact of mental toughness training (i.e., if individuals with specific genetic markers do better or worse with training).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Toughness Training | Experimental | Behavioral: Mental Toughness TrainingBehavioral training in goal-building, mindfulness, and the growth mindset. |
| College as Usual | No intervention | –no training provided |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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)
- Non-correctable vision or hearing problems
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 |
|---|---|---|
| Mental Toughness TrainingAlso: Resiliency trainingBehavioral training in goal-building, mindfulness, and the growth mindset. | Behavioural | Mental Toughness Training |
Primary outcome
Grade point average (GPA)
Time frame: Last semester that students are enrolled at the university, on average after 3.5 years.
GPA obtained from academic records
Retention in college
Time frame: Last semester that students are enrolled at the university, on average after 3.5 years.
Retention assessed as whether or not the student remains enrolled in the university.
Change in Connor---Davidson Resilience Scale (CD---RISC 10)
Time frame: Baseline and completion of training, on average after 4 weeks.
This measure assessed characteristics associated with resiliency and mental toughness.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Time frame: Baseline and completion of training, on average after 4 weeks.
This measure assesses symptoms of anxiety over the past 7 days.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Time frame: Baseline and completion of training, on average after 4 weeks.
This measure assesses symptoms of depression.
5 secondary outcomes
National Institute of Health Toolbox Perceived Stress Scale
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline and completion of training, on average after 4 weeks.
Resting state connectivity between brain regions
Time frame: Baseline and completion of training, on average after 4 weeks.
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 28 Aug 2023.
- 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.
Robin Aupperle, PhD principal investigator
Laureate Institute for Brain Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Toughness Training in people with Stress, Psychological, run by Laureate Institute for Brain Research, Inc. at 2 sites 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 8 inclusion and 5 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Grade point average (GPA) (time frame: Last semester that students are enrolled at the university, on average after 3.5 years.). The study lists 5 primary outcomes in all. 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 28 Aug 2023.