Clinical trial NCT04834765: Mindfulness-Based Art Therapy and Generation Z
Official title: Using the Arts as a Proactive Mental Health Strategy for Generation Z
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Keywords: Stress
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 intervention groups- Mindfulness only, Art Therapy only and combined Mindfulness based Art Therapy. 1 control group.
Primary purpose: TREATMENT

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.

The study will involve conducting a randomized control research design to meet the specific aims proposed. College students will be randomized into one of four group conditions: 1) MBAT; 2) AO; 3) MO; or 4) C. Interventions will be administered using Canvas, the pre-existing learning management system of Florida State University. Students will be able to join the study on Canvas, complete the self-report measures, and receive nearly all of the intervention material virtually, eliminating several of the issues with current mental health programs.

There are no studies that specifically examine the effects of mindfulness based art therapy on inflammation or stress mediators besides our preliminary findings (Beerse et al., 2019). Biological research in art therapy to date has been limited to cortisol analysis alone, with a focus on the impact of different art materials on physiological stress. The proposed study will identify several interrelated biological systems influenced by the intervention and position us to isolate key mechanistic processes. Importantly, the study will involve using non-invasive biological sampling of saliva and will use the TSST to mimic acute academic stress; neither approach has been applied to MBAT. Additionally, minimal research has been conducted on the application of MBAT with young adults except studies related to serious health diagnoses such as cancer, palliative care, or heart disease. Therefore, this project addresses this gap in research using a research strategy that studies a general population, ensures easy reproducibility, and promotes the advancement of related innovative practices in arts research. The proposed approach thus has the potential to innovate the delivery of a cost-effective and efficacious alternative therapy that could reduce the societal burden of mental health symptoms and build resiliency among young adults.

Eligibility criteria: 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

Primary outcomes:
measure: IL-6 Saliva Elisa
timeFrame: Change from Week 1 to twice during Week 5 conducted before and after TSST
measure: Salimetrics Cortisol EIA Test
timeFrame: Change from Week 1 to twice during Week 5 conducted before and after TSST
Secondary outcomes:
measure: Generalized Anxiety Disorder 7 (GAD-7)- Spitzer et al. 2006
timeFrame: Within first four weeks before study commences, then change from Week 1, to during Week 5, and then to 6 week follow-up
measure: Somatic Symptom Scale 8 (SSS-8)- Gierk et al. 2014 (A brief version of the popular Patient Health Questionnaire - 15)
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: 5 Facet Mindfulness Questionnaire Short Form (FFMQ)- Bohlmeijer et al. 2011
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: Perceived Stress Scale 10 (PSS-10)- Cohen, Kamarck and Mermelstein 2016
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: Patient Health Questionnaire 9 (PHQ-9)- Kroenke et al. 1999
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007
timeFrame: Change from Week 1, to during Week 5, and then to 6 week follow-up
measure: The DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM5_Level 1)
timeFrame: Within first four weeks before study commences
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Theresa Van Lith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Lith T, Cheshure A, Pickett SM, Stanwood GD, Beerse M. Mindfulness based art therapy study protocol to determine efficacy in reducing college stress and anxiety. BMC Psychol. 2021 Sep 3;9(1):134. doi: 10.1186/s40359-021-00634-2.