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

NCT04813198 | Completed

• 1 other identifier: 21184
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Group Meetings

Keywords

mental health; exercise therapy; first-generation college students; academic stress; peer support; aerobic exercise; physical activity; depression; anxiety; resilience

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Feasibility and Implementation Evaluation

  Assessed at week 6 and week 12 follow-up

• Intervention adherence

  Assessed across the 10-week intervention

• Knowledge of mental health services and resources

  Assessed at baseline, week 6 and week 12 follow-up

• Utilization of mental health services

  Assessed at baseline, week 6 and week 12 follow-up

• Self-reported leisure-time exercise

  Assessed at baseline, week 6 and week 12 follow-up

Other Outcomes (33)

• Demographics

  Assessed at baseline

• Grade-point average

  Assessed at baseline and week 12 follow-up.

• Perceived height and weight

  Assessed at baseline, week 6 and week 12 follow-up (assessed immediately post-intervention)

Study Arms (2)

TIPSTART

ACTIVE COMPARATOR

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

Wait-list Control

NO INTERVENTION

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.

Interventions

TIPSTART BEHAVIORAL

TIPSTART is a multimodal, cognitive behavior-based therapy integrating peer-sharing, technology, aerobic and resistance training.

TIPSTART

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rooms 284-284A

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• 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.

  PMID: 37811659 BACKGROUND

Related Links

• University of Illinois students interested in determining their study eligibility should contact us using this web form.

MeSH Terms

Conditions

Psychological Well-Being; Motor Activity; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Sean P Mullen, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and co-Is will be blinded to group status. Survey and cognitive assessments will be delivered online without any reference to group. Interventionists have been trained to deliver program content but they are blinded to the primary outcomes of the study. Interviewers who gather qualitative data will be blinded to group status and primary outcomes of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to either the intervention or a wait-list control condition.

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: February 4, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)