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Clinical Trials/NCT04834765
NCT04834765CompletedNot Applicable

Using the Arts as a Proactive Mental Health Strategy for Generation Z

Florida State University2 sites in 1 country86 target enrollmentStarted: April 5, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
2
Primary Endpoint
IL-6 Saliva Elisa

Study Overview

Brief Summary

A randomized controlled trial will be conducted to determine the unique role of the arts as a proactive mental health strategy for college students in Generation Z. Arts-only, mindfulness-only, and arts-based mindfulness interventions as they compare to a non-intervention control group. These interventions will be delivered using a minimal contact, web-based approach. Psychological and physiological outcomes will be measured to determine if arts-related interventions activate unique and distinguishable mechanisms of change compared to the mindfulness only intervention and non-intervention control groups. In addition, protective effects will be assessed based on student participants' response to an acute academic stress simulation. Qualitative data in the form of transcribed exit interviews will be analyzed to characterize the unique needs of Generation Z students, along with level of engagement, intervention acceptance and satisfaction.

Detailed Description

To reach the general population of college students, a technology-assisted approach is paramount. This multidisciplinary project will tease apart the mechanisms of change and implications of employing art therapy approaches for anxiety and stress reduction in college students at much more nuanced level than previously tested using the MBAT approach designed and comparing it to its main components as isolated interventions.

Based on the previous two studies and the accumulated research explored, the following study aims and hypotheses will guide the proposed study.

These are:

Aim 1. To examine the psychological and physiological differences between an Mindfulness-based Art Therapy (MBAT) intervention, its components as isolated Art-Only (AO) and Mindfulness-Only (MO) interventions, and a non-intervention control (C) using a minimal contact, web-based approach with students in Generation Z. Hypothesis 1: MBAT, AO, and MO will produce distinguishable differences in participant outcomes related to anxiety and stress symptomology, protective factors against chronic stress, and the biological stress response compared to a non-intervention control. Aim 2. To evaluate how these interventions affect participants' responses to an acute academic stress simulation using the TSST paradigm. Hypothesis 2: Results of self-report assessments and saliva samples collected during the acute academic stress simulation will produce distinguishable differences between group conditions, suggesting that the art-based interventions engage unique mechanisms of change compared to the Mindfulness-Only intervention. Aim 3. To determine which intervention produces the greatest participant satisfaction and acceptance. Hypothesis 3: Participants of the MBAT and AO interventions will report higher levels of study engagement, overall study satisfaction, and intervention acceptance compared to participants of the MO intervention and non-intervention control group conditions.

B. Research Design The study will investigate the fundamental science underlying MBAT, a specific evidence-based form of therapy that includes mindfulness practices like meditation and yoga, and art therapy. The application of MBAT as a proactive mental health strategy in a pragmatic real-world setting is urgently needed, particularly given the stigma that surrounds mental health. The multidisciplinary team includes detailed expertise in art therapy, clinical psychology, mindfulness, and biological mechanisms. The study will involving using simple but validated psychological and biological measures to evaluate relatively brief, technology-assisted art-based mindfulness.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Enrolled full time in an academic program at Florida State University and fit within age category of Generation Z

Exclusion Criteria

  • Regular tobacco smoking and over the age of 25

Outcomes

Primary Outcomes

IL-6 Saliva Elisa

Time Frame: Change from Week 1 to twice during Week 5 conducted before and after TSST

Tests for levels human Interleukin-6

Salimetrics Cortisol EIA Test

Time Frame: Change from Week 1 to twice during Week 5 conducted before and after TSST

Tests for salivary cortisol levels

Secondary Outcomes

  • Perceived Stress Scale 10 (PSS-10)- Cohen, Kamarck and Mermelstein 2016(Change from Week 1, to during Week 5, and then to 6 week follow-up)
  • Generalized Anxiety Disorder 7 (GAD-7)- Spitzer et al. 2006(Within first four weeks before study commences, then change from Week 1, to during Week 5, and then to 6 week follow-up)
  • Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989(Change from Week 1, to during Week 5, and then to 6 week follow-up)
  • Patient Health Questionnaire 9 (PHQ-9)- Kroenke et al. 1999(Change from Week 1, to during Week 5, and then to 6 week follow-up)
  • 5 Facet Mindfulness Questionnaire Short Form (FFMQ)- Bohlmeijer et al. 2011(Change from Week 1, to during Week 5, and then to 6 week follow-up)
  • Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007(Change from Week 1, to during Week 5, and then to 6 week follow-up)
  • The DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM5_Level 1)(Within first four weeks before study commences)
  • Somatic Symptom Scale 8 (SSS-8)- Gierk et al. 2014 (A brief version of the popular Patient Health Questionnaire - 15)(Change from Week 1, to during Week 5, and then to 6 week follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Theresa Van Lith

Associate Professor & Clinical Coordinator of Art Therapy

Florida State University

Study Sites (2)

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