Anxiety DepressionNCT04834765
Mindfulness-Based Art Therapy and Generation Z
A study testing Mindfulness-based art therapy, Art-only and Mindfulness-only in people with Anxiety Depression, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Mindfulness-based art therapy, Art-only and Mindfulness-only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2020to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrolled full time in an academic program at Florida State University and fit within age category of Generation Z
Who cannot join
- Regular tobacco smoking and over the age of 25
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32308
About this study
Official title: Using the Arts as a Proactive Mental Health Strategy for Generation Z
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.
Read the 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.
- 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.
- Conditions
- Anxiety Depression
- Being tested
- Mindfulness-based art therapy, Art-only, Mindfulness-only
- Keywords
- Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based art therapyOther
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.
Art-onlyOther
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.
Mindfulness-onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mindfulness-only |
| Art Therapy | Active comparator | Participants will engage in art therapy with the use of clay twice per week through prompts. Receives: 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. Receives: Other: Mindfulness-based art therapy |
| Control Group | No intervention | Participants will go about daily life as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Saliva Elisa
Tests for levels human Interleukin-6
Measured: Change from Week 1 to twice during Week 5 conducted before and after TSST
Salimetrics Cortisol EIA Test
Tests for salivary cortisol levels
Measured: 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
Assesses anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. Scores above 10 are considered to be in the clinical range.
Measured: 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)
Assesses presence and severity of common somatic symptoms. A score of 0 to 3 points were classified as "no to minimal" severity, a score of 4 to 7 points as "low," a score of 8 to 11 points as "medium," a score of 12 to 15 points as "high," and a score of 16 points or higher as "very high."
Measured: Change from Week 1, to during Week 5, and then to 6 week follow-up
Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989
Assesses sleep quality. The PSQI includes a scoring key for calculating a patient's seven sub scores, each of which can range from 0 to 3. The sub scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Measured: 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
Assesses 5 facets of mindfulness- observation, description, awareness of actions, non-judgement and non-reaction. Items scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores were computed by summing the scores on the individual items. Facet scores range from 8 to 40 (except for the nonreactivity facet, which ranges from 7 to 35), with higher scores indicating more mindfulness.
Measured: 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
Assesses perceptions of stress. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items.
Measured: 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
Measures depression severity. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 0- not at all, 1- several days, 2- more than half the days, 3- nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27. 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.
Measured: Change from Week 1, to during Week 5, and then to 6 week follow-up
Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007
Assesses burnout via disengagement and exhaustion. The subject is presented with a series of 16 statements, which they may agree or disagree with and is asked to indicate the degree of agreement or disagreement. The 16 items are divided between two subscales, the items are also summed to form two sub-totals. Disengagement items: 1, 3, 6, 7, 9, 11, 13 and 15; Exhaustion items: 2, 4, 5, 8, 10, 12, 14 and 16. For items 2, 3, 4, 6, 8, 9, 11 and 12, the scale is reversed, with Strongly Agree answers scoring 4 and Strongly Disagree answers scoring 1.
A total OLBI score can be reached by summing the two sub-totals. The higher the score, the greater the level of burnout. Some therapists may categorize the OLBI scores under low, medium or high but no widespread consensus exists.
Measured: 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)
Consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Nineteen of the 25 items on the measure are each rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The higher the score the more severity of the symptoms. The suicidal ideation, suicide attempt, and substance abuse items are each rated on a "Yes, No, or Don't Know" scale.
Measured: Within first four weeks before study commences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 Apr 2020
- Primary completion22 Feb 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 3 intervention groups- Mindfulness only, Art Therapy only and combined Mindfulness based Art Therapy. 1 control group.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Van Lith, Florida State University
- Investigators
- Theresa Van Lith, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834765
- Sponsor's protocol ID
- TVanLith
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34479649
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Arts as a Proactive Mental Health Strategy for Generation Z
- ClinicalTrials.gov ID
- NCT04834765
- Acronym / sponsor ID
- TVanLith
- Conditions
- Anxiety Depression
- Keywords
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3 intervention groups- Mindfulness only, Art Therapy only and combined Mindfulness based Art Therapy. 1 control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Active comparator | Other: Mindfulness-onlyParticipants 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. |
| Art Therapy | Active comparator | Other: Art-onlyParticipants will engage in art therapy with the use of clay twice per week through prompts. |
| Mindfulness based Art Therapy | Active comparator | Other: Mindfulness-based art therapyParticipants 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. |
| Control Group | No intervention | –Participants will go about daily life as usual. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Enrolled full time in an academic program at Florida State University and fit within age category of Generation Z
Key exclusion criteria (1 listed)
- Regular tobacco smoking and over the age of 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based art therapyThe 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. | Other | Mindfulness based Art Therapy |
| Art-onlyThe 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. | Other | Art Therapy |
| Mindfulness-onlyThe 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. | Other | Mindfulness |
Primary outcome
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
8 secondary outcomes
Generalized Anxiety Disorder 7 (GAD-7)- Spitzer et al. 2006
Time frame: 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)
Time frame: Change from Week 1, to during Week 5, and then to 6 week follow-up
Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Week 1, to during Week 5, and then to 6 week follow-up
Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007
Time frame: 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)
Time frame: Within first four weeks before study commences
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 34479649Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Van Lith, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based art therapy, Art-only and Mindfulness-only in people with Anxiety Depression, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Saliva Elisa (time frame: Change from Week 1 to twice during Week 5 conducted before and after TSST). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.