NCT04834765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

March 17, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

Stress

Outcome Measures

Primary Outcomes (2)

  • IL-6 Saliva Elisa

    Tests for levels human Interleukin-6

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

  • Salimetrics Cortisol EIA Test

    Tests for salivary cortisol levels

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

Secondary Outcomes (8)

  • 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

  • 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

  • Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989

    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

  • 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

  • +3 more secondary outcomes

Study Arms (4)

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.

Other: Mindfulness-only

Art Therapy

ACTIVE COMPARATOR

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

Other: Art-only

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.

Other: Mindfulness-based art therapy

Control Group

NO INTERVENTION

Participants will go about daily life as usual.

Interventions

The researchers developed a novel MBAT intervention consisting of 10 easily reproducible, clay-based MBAT directives, administered through an online platform delivery strategy. By developing an MBAT intervention that uses an online delivery strategy, the researchers realized it may have the potential of decreasing demands placed on counseling centers.

Mindfulness based Art Therapy

The AO modules consist of an open-ended art-making exercise, with minimal direction. The AO intervention is designed as an 'art for art's sake' intervention with the focus on the art-making and less on outcome or product. Participants are asked to pull their ball of clay out and spend ten minutes creating a form from the clay to visually express their experience in the present moment.

Art Therapy

The MO modules consist of only the mindfulness practices from the ABM intervention. The participants to follow along with a five-minute light yoga sequence, where asanas (yoga postures) are cued with breath. Yoga, for the purposes of the study, is explicitly defined to participants as the unity of breath with body movement. Poses were chosen based on their accessibility to a variety of body types and abilities, and chosen because they are documented to aid in grounding, increased haptic awareness, lowered levels of stress and anxiety, and restoration.

Mindfulness

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Regular tobacco smoking and over the age of 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32308, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Theresa Van Lith, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 3 intervention groups- Mindfulness only, Art Therapy only and combined Mindfulness based Art Therapy. 1 control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Clinical Coordinator of Art Therapy

Study Record Dates

First Submitted

March 17, 2021

First Posted

April 8, 2021

Study Start

April 5, 2020

Primary Completion

February 22, 2022

Study Completion

April 5, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations