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临床试验/NCT04834765
NCT04834765已完成不适用

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

Florida State University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
IL-6 Saliva Elisa

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Regular tobacco smoking and over the age of 25

研究组 & 干预措施

Mindfulness

Active Comparator

Participants will be engaging in a mindfulness tasks twice per week for 5 weeks in which they will learn techniques through the use of yoga, meditation and breathwork.

干预措施: Mindfulness-only (Other)

Art Therapy

Active Comparator

Participants will engage in art therapy with the use of clay twice per week through prompts.

干预措施: Art-only (Other)

Mindfulness based Art Therapy

Active Comparator

Participants will engage in both mindfulness activities and art therapy twice per week and will learn techniques through the use of yoga, mediation, breathwork and art.

干预措施: Mindfulness-based art therapy (Other)

Control Group

No Intervention

Participants will go about daily life as usual.

结局指标

主要结局

IL-6 Saliva Elisa

时间窗: Change from Week 1 to twice during Week 5 conducted before and after TSST

Tests for levels human Interleukin-6

Salimetrics Cortisol EIA Test

时间窗: Change from Week 1 to twice during Week 5 conducted before and after TSST

Tests for salivary cortisol levels

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Van Lith

Associate Professor & Clinical Coordinator of Art Therapy

Florida State University

研究点 (1)

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