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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Group Meetings

Intervention / Treatment
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* Behavioral: TIPSTART


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to either the intervention or a wait-list control condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIPSTART<br>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. | Behavioral: TIPSTART<br>* TIPSTART is a multimodal, cognitive behavior-based therapy integrating peer-sharing, technology, aerobic and resistance training.<br>|
| No Intervention: Wait-list Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The seven-item Generalized Anxiety Disorder (GAD-7) questionnaire will be used as our primary measure of anxiety. GAD-7 scores range from 0 (not at all) to 3 (nearly every day) and a composite score is computed by summing all responses. Scores range from 0 to 21 and will be recoded for ease of interpretation (higher scores will be interpreted as more favorable). | Change will be assessed from baseline to 12-week follow-up (assessed immediately post-intervention) | 
| Depression | The nine-item Patient Health Questionnaire (PHQ-9) will be used as our primary measures of depression. PHQ-9 scoring is identical to the GAD-7, however, the additional two items in increase the range from 0 to 27. Scores will be recoded for ease of interpretation (higher scores will be interpreted as more favorable). | Change will be assessed from baseline to 12-week follow-up (assessed immediately post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Implementation Evaluation | One-hour interviews were conducted with a sub-sample of participants. Specifically, participants were asked open-ended about aspects of their life (financial, emotional, familial, social, health) they felt were most impacted by their experiences in the TIPSTART program, as well as the most memorable/standout services. In addition, participants were asked about any negative or unintended consequences of their participation, such as deterioration of symptoms, adverse events, novel symptoms, unwanted events, etc. | Assessed at week 6 and week 12 follow-up | 
| Intervention adherence | The percentage of sessions attended out of 10, as well as the percentage of total weeks participants reported adherence to the minimum physical activity prescription (public health guidelines of 150 minutes) and weekly mental exercises, will be used to represent adherence to our TIPSTART intervention. | Assessed across the 10-week intervention | 
| Knowledge of mental health services and resources | Participants were asked to indicate (by checking boxes), Which of the following on-campus/ remote mental health resources at your university are you aware of (whether or not you have utilized them). Please check all that apply. | Assessed at baseline, week 6 and week 12 follow-up | 
| Utilization of mental health services | Please describe any in-person or remote mental health resources you have utilized (not affiliated with your university) over the past 5 weeks. This could include, but is not limited to in-person talk therapy or telecounseling with a private practice therapist, a rehabilitation center, outpatient clinic, app-based services, etc. Which of the following on-campus/ remote mental health resources at UIUC have you used in the past 5 weeks? Which of the follow on-campus/ remote mental health resources at UIUC have you used the most in the past 5 weeks? (if you have not used any, please select None). How many times have you used this resource in the past 5 weeks? | Assessed at baseline, week 6 and week 12 follow-up | 
| Self-reported leisure-time exercise | Physical activity at baseline will be assessed via the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTEQ; Godin, 2011). The GLTEQ assesses leisure-time activity across three modes of activity: strenuous, moderate, and mild, in terms of frequency and duration. Weekly frequencies of strenuous, moderate, and mild activities were multiplied by nine, five, and three, respectively to create the total score or number of units. According to this score, 24 units or more is indicative of an active individual, whereas any score below 24 is indicative of a non-active individual. | Assessed at baseline, week 6 and week 12 follow-up | 
| Process of Recovery | The 15-item Questionnaire about the Process of Recovery (QPR) will be used to assess meaningful aspects of recovery. Each item is scored on a 4-point scale (0= disagree strongly, 1=disagree, 2=neither agree nor disagree, 3=agree, 4=agree strongly) and items are summed to create a composite. Higher scores are indicative of recovery. | Assessed at baseline, week 6 and week 12 follow-up | 
| Resilience | The 17-item Adult Resilience Measured-Revised (ARM-R; Jeffries, McGarrigle, & Ungar, 2018) will be used to assess perceived social-ecological resilience. The ARM-R utilizes a 5-point Likert scale (ranging from 1=Not at all to 5=A lot) and it has two subscales: personal (10 items) and relational (7 items) resilience. Items are summed creating minimum and maximum scores of 10 to 50 for personal resilience and 10 to 35 for relational resilience, where higher scores reflect higher resilience. | Assessed at baseline, week 6 and week 12 follow-up | 
| Perceptions of Academic Stress | The 18-item Perceptions of Academic Stress (PAS) scale by Bedewy and Gabriel (2015) was used to assess academic domain-specific stress. For example, participants are asked to indicate the extent to which they agree with statement such as, Am confident that I will be a successful student, on a 5-point Likert scale (1=Strongly disagree, 5=Strongly agree). The PAS scale also addresses sources of stress, such as, Teachers have unrealistic expectations of me (1=Strongly agree, 5=Strongly disagree). Subscale scores will be computed by summing respective items and calculating an un-weighted averaged. Some scores will be reversed to ensure that lower composite scores reflect lower perceived stress. | Assessed at baseline, week 6 and week 12 follow-up | 
| Academic Engagement | Academic engagement was assessed via self-report using a 4-item questionnaire by Hu and Wolniak (2013). Specifically, participants were asked to indicate the frequency they they worked with other students on schoolwork outside of class, discussed readings or classes with students and faculty outside of class, and worked harder than thought to meet an instructor's expectations on a 6-point Likert scale (response options ranged from 1=less than once a month to 6=four or more times a week). Items are summed and averaged and higher scores indicate higher levels of academic engagement. | Assessed at baseline, week 6 and week 12 follow-up | 
| Social Engagement | Social engagement was assessed via self-report using a scale by Hu and Wolniak (2013). Specifically, participants were asked to indicate the frequency they they participate in events sponsored by a fraternity or sorority, residence hall activities, events by groups reflecting own culture heritage, and community service activities on a 5-point Likert scale (response options ranged from 1=never to 5=very often). Items are summed and averaged and higher scores indicate higher levels of academic engagement. | Assessed at baseline, week 6 and week 12 follow-up | 
| Schoolwork life-balance | Six items (e.g. Because of my school work, I have no time, I have enough time for my friends) were used to assess perceived time availability for school and social life. Items were rated on a 6-point Likert ranging from Completely Disagree to Completely Agree. Items 2 and 3 are reverse-coded. A composite score is derived by adding and averaging, with higher scores reflecting greater balance between schoolwork and life. | Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention) | 
| Self-efficacy to regulate school-life | The Self-efficacy to Regulate Work and Life Questionnaire is a 5-item questionnaire that assesses how confident individuals are in regulating their work and non-work domains (Chan et al., 2016).The five items include: 1) How confident are you in changing your lifestyle to achieve a good work-life balance?, 2) How confident are you in finding out how to balance work and life?, 3) How confident are you in achieving your ideal work-life balance?, 4) How confident are you in implementing strategies to achieve work-life balance?, and 5) How confident are you in inventing ways to balance your work and life?. Responses to all items are based on a scale ranging from 0 (cannot do at all) to 100 (highly certain can do). The composite score is calculated by summing and averaging the five items, with higher scores indicating that individuals are more confident in their abilities to cope with work-life challenges. | Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention) | 
| Physical activity self-regulation | The Physical Activity Self-Regulation Scale (PASR-12; Umstattd, Motl, Wilcox, Saunders, & Watford, 2009) will be used to assess the use of self-regulation strategies for engaging in physical activity. The PASR-12 is a 12-item questionnaire with responses ranging from 1 (never) to 5 (very often). A total score can be calculated by summing up responses to all the items. There are also six subscales (self-monitoring, goal-setting, social support, reinforcement, time management, and relapse prevention), however, research by our lab has found that this scale is not uni-dimensional. We will use a modified version of the scale. Higher score reflects higher use of self-regulation strategies. | Assessed at baseline, week 6 and week 12 follow-up | 
| Exercise-related planning | The Exercise Planning and Schedule Scale (EPSS; Rovniak, Anderson, Winett, & Stephens, 2002) is a 10-item questionnaire that assesses exercise scheduling and planning. Each question is based on a 5-point Likert scale, ranging from 1 (does not describe me) to 5 (describes me completely). The EPSS composite score is calculated by reverse-scoring items 2, 3, and 7 then summing and averaging the 10-items to create a composite score. Higher scores indicate more scheduling and planning done for exercise. In addition, we used a novel questionnaire asking participants the extent to which the following 5 statements are true (4-point Likert scale range: 1=Not at all true, 4 = Absolutely true). For the next month, I have already planned... which days (frequency; F), the intensity (I), how long (time; T), which types (T), and where (location; L) I will exercise. F.I.T.T.L. scores will be averaged and higher scores represent greater planning. | Assessed at baseline, week 6 and week 12 follow-up | 
| Self-efficacy to overcome barriers to exercise | A 13-item questionnaire will be used to assess self-efficacy specific to possible barriers affecting exercise adherence. All items will be answered on a 0-100% Likert scale in increments of 10%. Prior research suggests that this may not be a uni-dimensional scale and therefore a composite will be based on a 4-item composite. These four items best reflect participants' confidence to self-regulate in the face of actual barriers, including exercising regularly in the face of bad weather, while on vacation, without encouragement, and when under personal stress. These four items will be averaged to generate our main outcome of interest, and the remaining nine items will be assessed for exploratory purposes. | Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention) | 
| Self-efficacy for lifestyle physical activity | Self-efficacy to engage in physical activity will be assessed using the Lifestyle Self-efficacy Scale (E McAuley et al., 2009), which asks participants about their belief in their ability to be physically active five or more times per week at a moderate intensity, for at least 30 minutes, for six months. | Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention) | 
| Social support for exercise | Participants were asked to indicate the frequency (0=Never, 4=Very Often) that they received companionship, informational, and esteem support from friends or an expert (6 total sub-scales derived from the Multidimensional Social Support Scale; Chogahara, 1999). Each 5-item sub-scale score will be computed by summing and averaging the five numeric responses. Higher scores reflect higher levels of perceived social support. | Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, exercise therapy, first-generation college students, academic stress, peer support, aerobic exercise, physical activity, depression, anxiety, resilience