Clinical trial NCT04813198: Feasibility of Therapy Integrating Peer-sharing, Technology, Aerobic and Resistance Training (TIPSTART)
Official title: Feasibility and Preliminary Efficacy Testing of Therapy Integrating Peer-sharing, Technology, Aerobic and Resistance Training (TIPSTART) to Reduce Symptoms of Mental Illness in First-generation College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Group Meetings
Keywords: mental health
exercise therapy
first-generation college students
academic stress
peer support
aerobic exercise
physical activity
depression
anxiety
resilience
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the intervention or a wait-list control condition.
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled clinical trial with first-generation college students with symptoms of mental illness is to test the preliminary feasibility and efficacy of TIPSTART, a multi-faceted, mental health and exercise training program-involving 5.5 hours of training delivered via assistance of remote technology, a licensed therapist and certified exercise behavior change specialist, and supported by peer pods-relative to a group receiving usual care. Students will confirm they are not currently treated with medication but have received mental health services in the past two years, and meet symptom cutoff criteria using a standard field screening assessment. It is hypothesized that the 10-week training program initiated at the onset of an academic semester will improve students' symptoms of anxiety and depression. Further, it is also expected that greater physical activity, self-efficacy, and social and academic engagement among participants in the TIPSTART group as compared to the usual care condition. Finally, the potential role of TIPSTART in changes in resilience, self-regulatory functioning and schoolwork-life balance will be explored.

Detailed description: First-generation college students are at risk of serious mental illness. Relative to their peers, they are more likely to work full time, take fewer classes, use public transportation, and engage less with on-campus programs. Further, they report more traumatic stress, lower life satisfaction and less support from parents and peers. These findings are compounded by nationwide estimates of rising mental health issues across college campuses, where nontraditional students with financial hardship and/ or care-giving burdens represent the majority, and counseling services are increasingly under-resourced and overburdened. Moreover, less than 50% of college students are meeting public health guidelines for physical activity participation, a health behavior known to mitigate risk and enhance mental health.

Traditional four-year colleges and universities represent an opportunity to implement evidence-based mental health services, but many campuses are disconnected, low mental health-resource environments lacking well-coordinated programs specifically tailored for first-generation students, particularly cognitive behavior therapy (CBT) or programs guided by CBT principles, in concurrence with physical activity guidance and support. Evidence suggests that multimodal programs consisting of therapy integrating peer-support (in the form of pods), technology, aerobic plus resistance training (TIPSTART) has the potential to increase self-efficacy and self-regulatory strategies, utilization and maintenance of mental health services and behavior change techniques, and ultimately, reduce symptoms of mental illness. In the last decade, digital health interventions (e.g. smartphone apps) have been used with college-age populations to make therapy more accessible and exercise more enjoyable and socially-supported. App-based interventions have been successfully delivered as standalone interventions and have yielded positive effects on mental health outcomes, socio-emotional functioning and health behavior engagement.

The purpose of this randomized controlled clinical trial is to test the feasibility and preliminary efficacy and implementation of TIPSTART, a multi-faceted, mental health and exercise training program involving 5.5 hours of supervised training delivered via assistance of remote technology, a therapist and exercise behavior change specialist, and supported by peer pods (relative to a wait-list control group who will receive usual care) among first-generation college students with symptoms of mental illness. Students will confirm receipt of mental health services in the past two years, and meet cutoff criteria using a standard field screening assessment. It is hypothesized that the 10-week training program initiated at the onset of an academic semester will improve students' symptoms of anxiety and depression. Further, it is also expected that greater physical activity, self-efficacy, and social and academic engagement among participants in the TIPSTART group as compared to the usual care condition. Finally, the potential role of TIPSTART in changes in resilience, self-regulatory functioning and schoolwork-life balance will be explored.

Eligibility criteria: Inclusionary Criteria

* Enrolled at UIUC as a student with confirmed first-generation status (18 to 34 years old)
* Not currently taking medication for mental illness but have symptoms of mental illness and/or able to provide verifiable evidence of accessing mental health services in the past 2 years (proof of receipt of services is substitutable for record of diagnosis). Note: Should taking regular medication become necessary, participation in this study will in no way be impacted.
* Low-active (e.g., walk \< two days/week, 20 minutes/day for last three months)
* English-speaking
* Not concurrently participating in another academic program, clinical trial or commercial program that may affect physical activity, diet, sleep, or meditation
* Not pregnant/lactating
* No pre-existing physical condition, recent injury or surgery that might be exacerbated by aerobic and resistive exercise
* Have smartphone (or willing to use portable device supplied by lab) and willing to install and use 'WellTrack' and 'Remind' apps and to allow researchers to pull data from apps (such as exercise entries and goals) and in-phone usage statistics of those apps at follow-up.

Exclusionary Criteria

* Not enrolled at UIUC as a student with first-generation status (18 to 34 years old)
* Taking medication for mental health condition or have no mental illness symptoms or unable to provide verifiable evidence of accessing mental health services in the past 2 years (proof of receipt of services is substitutable for record of diagnosis)
* Too active (e.g., walk \> two days/week, \>20 minutes/day for last three months)
* Not English-speaking
* Concurrently participating in another academic program, clinical trial or commercial program that may affect physical activity, diet, sleep, or meditation
* Pregnant/lactating
* Have pre-existing physical condition, recent injury or surgery that might be exacerbated by aerobic and resistive exercise
* Do not own smartphone (or are unwilling to use portable device supplied by lab) and/ or unwilling to install and use 'WellTrack' and 'Remind' apps and to allow researchers to pull data from apps and in-phone usage statistics of those apps at follow-up.

Primary outcomes:
measure: Anxiety
timeFrame: Change will be assessed from baseline to 12-week follow-up (assessed immediately post-intervention)
measure: Depression
timeFrame: Change will be assessed from baseline to 12-week follow-up (assessed immediately post-intervention)
Secondary outcomes:
measure: Feasibility and Implementation Evaluation
timeFrame: Assessed at week 6 and week 12 follow-up
measure: Intervention adherence
timeFrame: Assessed across the 10-week intervention
measure: Knowledge of mental health services and resources
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Utilization of mental health services
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Self-reported leisure-time exercise
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Process of Recovery
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Resilience
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Perceptions of Academic Stress
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Academic Engagement
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Social Engagement
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Schoolwork life-balance
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Self-efficacy to regulate school-life
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Physical activity self-regulation
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Exercise-related planning
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Self-efficacy to overcome barriers to exercise
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Self-efficacy for lifestyle physical activity
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Social support for exercise
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
Other outcomes:
measure: Demographics
timeFrame: Assessed at baseline
measure: Grade-point average
timeFrame: Assessed at baseline and week 12 follow-up.
measure: Perceived height and weight
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Economic hardship
timeFrame: Assessed at baseline
measure: College shock
timeFrame: Assessed at baseline
measure: Medication use
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Caffeine use
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Alcohol use
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Smoking behavior
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Health status
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Perceived Stress
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Exercise self-efficacy
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Exercise self-schema
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Eating identity
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Exercise-related outcome expectations
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Anticipated negative affect related to exercise
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Exercise motivation
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Sleep quality
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Frequency of forgetting
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Memory strategies
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Exercise-specific memory self-efficacy
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Exercise Experience
timeFrame: Assessed at baseline
measure: Fitness Technology Experience
timeFrame: Assessed at baseline
measure: Future time perspective
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Mindfulness
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Grit
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Personality dimensions
timeFrame: Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)
measure: Sitting time
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Active choices
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Cardiorespiratory fitness
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Adverse and unintended events
timeFrame: Assessed weekly during intervention sessions
measure: Intentions
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
measure: Attention checks
timeFrame: Assessed at baseline, week 6 and week 12 follow-up
Locations:
city: Urbana
country: United States
facility: Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rooms 284-284A
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mullen S, Luo Y, Adamek J, Phansikar M, Mackenzie M, Roberts B, Larrison CR. Path Analysis of Effects of First-Generation Status on Physical Activity and 4-Year College Degree Completion. J Evid Based Soc Work (2019). 2024 Jan 2;21(1):104-116. doi: 10.1080/26408066.2023.2265922. Epub 2024 Jan 3.