Feasibility of Therapy Integrating Peer-sharing, Technology, Aerobic and Resistance Training (TIPSTART)

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Group Meetings

Treatments: Behavioral: TIPSTART

Study type: Interventional

Funder types: Other

Identifiers

NCT04813198

21184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

TIPSTART

Active Comparator group

Description:

Following baseline testing, the study orientation and randomization, the TIPSTART group will engage in 5.5 hours (30 minutes, on 11 separate occasions, over 10 weeks) of training delivered through Zoom and supported by instructional and communication apps, and that is further supervised by our TIPSTART study navigators who will provide motivational support and detailed lifestyle behavioral prescriptions (150 to 300 minutes per week of aerobic and strength training, with mental practice of material discussed each week). Participants will also be asked to complete approximately 3 total hours of repeated testing that occurs online via surveys and face-to-face interviews for the 12-week study.

Treatment:

Behavioral: TIPSTART

Wait-list Control

No Intervention group

Description:

Following baseline testing, the study orientation and randomization, the wait-list control group will be asked to continue living life as usual until their delayed TIPSTART program is initiated. Participants will be asked to complete repeated online surveys and face-to-face interviews during the first 12 weeks, concurrently, with participants assigned to the TIPSTART intervention.