AnxietyDRAMANCT07033052
Developing Resilience and Anxiety Management Through the Arts
A study testing Improvisation + Wellness, Improvisation and Social Craft in people with Anxiety and Depression, run by Case Western Reserve University at 1 site in United States.
Trial summary
The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anxiety, Depression, Mood
- What is being tested?
- Improvisation + Wellness, Improvisation and Social Craft
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 8 and 17 years of age
- Individuals must have parental/guardian consent
- Elevated levels of anxiety or depression based on
- Screen for Child Anxiety Related Disorders (SCARED) score of 15 or higher, or;
- Revised Children's Anxiety and Depression Scale (RCADS) Depression T score of 65 or higher, or;
- Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinician severity rating of 3 on any anxiety disorder or on a mood-related disorder
Who cannot join
- Diagnosed with Conduct Disorder or with behavioral symptoms that would make it difficult for the child/adolescent to participate in the group or comply with directions given by the group leader (such as difficulty following instructions, difficulty staying in one's seat, defiance of adults, harming animals or people, threatening others, getting into physical fights, hyperactivity, impulsivity, difficulty waiting for one's turn, etc.)
- Autism or developmental delays
- Psychotic symptoms or active suicidality
- Active Eating Disorders that raise concerns about morbidity and therefore need to be addressed in an intervention and actively monitored
- Unsteady dosage or recently or impending changes to psychotropic medication(s)
- Non-English-speaking individuals
- Wards of the State
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Amy Przeworski, PhD, 216-368-5022, soarlab@case.edu
About this study
Official title: Developing Resilience and Anxiety Management Through the Arts (DRAMA) 2
The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.
Read the detailed description
The purpose of this study is to observe the benefits of theatrical improvisation exercises paired with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a craft control group on reducing elevated levels of anxiety and depression in children and adolescents. It is possible that improvisational techniques could reduce anxiety and depression symptoms because they involve being spontaneous and going into social situations as well as creating something larger than oneself through the group (e.g., creating a scene, working together, etc.). It is also possible that the addition of CBT techniques might lead to a further reduction in anxiety and depression. The study will compare these to a control craft group where youth work on craft projects. The researchers hypothesize that improvisation exercises paired with CBT techniques will be more effective at reducing anxiety and depression than improvisational exercises alone, which we expect will be more effective than a craft group. This improvisation course will not be implemented by licensed therapists or psychologists. Group leaders will be undergraduates, schoolteachers, and graduate students without a background in therapy or counseling (e.g., drama students, music students, etc.) As such, it is important to note that this should not be considered "therapy" or an "intervention." It should not replace intensive treatment for children or adolescents who require a higher level of treatment. Rather, it can be considered a supplementary or preventative group that can help children or adolescents manage feelings of anxiety or depression. The goal of the study is to reduce existing levels of anxiety and depression, prevent the development of new symptoms, and prevent exacerbation of symptoms.
- Conditions
- Anxiety, Depression, Mood
- Being tested
- Improvisation + Wellness, Improvisation, Social Craft
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvisation + WellnessBehavioural
Theatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques
ImprovisationBehavioural
Theatrical improvisation exercises (the theatrical art of performance and storytelling without a script) will be completed in this arm. These exercises will be fairly similar to that from the improvisation + wellness but without the wellness techniques.
Social CraftBehavioural
Participants assigned to the Social Craft group will engage in arts and crafts projects and activities
| Study group | Role | What they receive |
|---|---|---|
| Improvisation + Wellness | Experimental | The Improvisation + Wellness arm will include a variety of techniques based on Cognitive Behavioral Therapy (CBT): behavior activation, mindfulness, relaxation techniques, exposure, and cognitive restructuring. The improvisation techniques will include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations). Receives: Behavioral: Improvisation + Wellness |
| Improvisation | Experimental | The improvisation alone arm involves the same improv techniques as the improv + wellness arm, but without the wellness techniques. Improv techniques include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations). Receives: Behavioral: Improvisation |
| Social Craft | Active comparator | The social craft group involves youth connecting with other youth while completing craft projects. Receives: Behavioral: Social Craft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Anxiety and Depression (based on Parent Report)
Child anxiety and depression will be measured using a parent-report. The Revised Child Anxiety and Depression Scale Parent Report (RCADS-P) is a 47-item measure that assesses parent-report of child anxiety and depressive symptoms. Parents respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS-P has excellent psychometric properties, including high internal consistency and convergent validity. Higher scores indicate higher anxiety/depression symptoms. A T-score is created based on the child's age and gender.
Measured: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Child Anxiety and Depression (based on youth report)
Child anxiety and depression will also be measured using a youth report. The Revised Child Anxiety and Depression Scale (RCADS) is a 47 item measure that assesses child report of child anxiety and depressive symptoms. Youth respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS has been translated from English into Spanish, Chinese, Dutch, and Danish. The measure has good discriminant validity, internal consistency, and convergent validity and discriminates between anxiety and depression.
Measured: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Cognitive Behavioral Technique (CBT) Skill Knowledge
This is a measure designed by the research team that assesses cognitive-behavioral techniques (CBT) Skills knowledge. Participants indicate whether each item is true or false. Items ask about whether thoughts and feelings influence one another, whether avoidance is a good idea when one is anxious about something, present-moment focus/mindfulness, diaphragmatic breathing, activity scheduling, progressive muscle relaxation, etc.
Measured: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
Cognitive Behavioral Technique (CBT) Skills Use
This is a measure designed by the research team that assesses cognitive-behavioral technique (CBT) Skills use. Participants indicate how often they use each skill on a scale from Never (0) to At least once a day (5). Skills assessed included diaphragmatic breathing, cognitive restructuring, facing your fears, muscle relaxation, being mindful, scheduling pleasant activities, etc.
Measured: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
Secondary outcomes (4)
Youth mindfulness
Youth mindfulness will be measured using the Child and Adolescent Mindfulness Measure. The Child and Adolescent Mindfulness Measure (CAMM) is a youth report measure that assesses present-moment awareness and non-judgmental responses to internal experiences. Youth rate each item on a five-point Likert scale ranging from 0 ("never true") to 4 "always true." The scale yields a total score with lower scores indicating greater mindfulness. Internal consistency of the scale is strong (α = .81-.84) and it correlates negatively with internalizing, externalizing, somatic symptoms.
Measured: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Connectedness
Youth will complete the Hemingway Measure of Adolescent Connectedness, which is a measure of connectedness across multiple spheres (neighborhood, friends, self-in-the-present, parents, siblings, school, peers, teachers, future, reading, kids from other cultures, religion, romantic partner, mother, and father). This study will only include the friends, self-in-the-present, parents, peers, and future subscales. Participants rate each item on how accurate it is on a Likert scale ranging from Not true (1), Sort of True(2), True (3), and Very True (4). Higher scores indicate greater connectedness within the particular sphere that the subscale is measuring.
Measured: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Emotion regulation
Difficulties in Emotion RegulationScale (DERS) is a 36-item measure of emotion regulation in adults and youth. Participants rate how frequently they experience each item on a scale of 1 (almost never), 2 (sometimes), 3 (about half the time), 4 (most of the time), 5 (almost always). The DERS consists of the 6 subscales: emotional clarity, emotional awareness, goal-orientation in the presence of distress, perceived access to ER strategies, ability to control impulsive behavior in the presence of distress, and nonacceptance of emotions. Higher scores indicate higher levels of difficulties in the particular type of emotion regulation difficulty assessed by each subscale.
The measure has been used in children and adolescents across a variety of ages and has good psychometric properties including good internal consistency, test-retest reliability, adequate construct, and predictive validity.
Measured: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Self-esteem
Self-Esteem will be measured by The Rosenberg Self-Esteem Scale (RSES), a tool consisting of 10 statements rated on a four-point Likert scale. Each statement is rated on a scale from 0 to 3, with higher scores indicating higher self-esteem.
Measured: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Expanding Horizons Initiative
- Responsible party
- Sponsor
- Investigators
- Amy Przeworski, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033052
- Sponsor's protocol ID
- STUDY20241298
- Other IDs
- NEA AWARD 1891861-38-22
- Acronym
- DRAMA
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Resilience and Anxiety Management Through the Arts (DRAMA) 2
- ClinicalTrials.gov ID
- NCT07033052
- Acronym / sponsor ID
- DRAMA / STUDY20241298
- Conditions
- Anxiety, Depression, Mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Expanding Horizons Initiative
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Jun 2025 (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.
The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.
Detailed description
The purpose of this study is to observe the benefits of theatrical improvisation exercises paired with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a craft control group on reducing elevated levels of anxiety and depression in children and adolescents. It is possible that improvisational techniques could reduce anxiety and depression symptoms because they involve being spontaneous and going into social situations as well as creating something larger than oneself through the group (e.g., creating a scene, working together, etc.). It is also possible that the addition of CBT techniques might lead to a further reduction in anxiety and depression. The study will compare these to a control craft group where youth work on craft projects. The researchers hypothesize that improvisation exercises paired with CBT techniques will be more effective at reducing anxiety and depression than improvisational exercises alone, which we expect will be more effective than a craft group. This improvisation course will not be implemented by licensed therapists or psychologists. Group leaders will be undergraduates, schoolteachers, and graduate students without a background in therapy or counseling (e.g., drama students, music students, etc.) As such, it is important to note that this should not be considered "therapy" or an "intervention." It should not replace intensive treatment for children or adolescents who require a higher level of treatment. Rather, it can be considered a supplementary or preventative group that can help children or adolescents manage feelings of anxiety or depression. The goal of the study is to reduce existing levels of anxiety and depression, prevent the development of new symptoms, and prevent exacerbation of symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improvisation + Wellness | Experimental | Behavioral: Improvisation + WellnessThe Improvisation + Wellness arm will include a variety of techniques based on Cognitive Behavioral Therapy (CBT): behavior activation, mindfulness, relaxation techniques, exposure, and cognitive restructuring. The improvisation techniques will include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations). |
| Improvisation | Experimental | Behavioral: ImprovisationThe improvisation alone arm involves the same improv techniques as the improv + wellness arm, but without the wellness techniques. Improv techniques include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations). |
| Social Craft | Active comparator | Behavioral: Social CraftThe social craft group involves youth connecting with other youth while completing craft projects. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between 8 and 17 years of age
- Individuals must have parental/guardian consent
- Elevated levels of anxiety or depression based on
Key exclusion criteria (7 listed)
- Diagnosed with Conduct Disorder or with behavioral symptoms that would make it difficult for the child/adolescent to participate in the group or comply with directions given by the group leader (such as difficulty following instructions, difficulty staying in one's seat, defiance of adults, harming animals or people, threatening others, getting into physical fights, hyperactivity, impulsivity, difficulty waiting for one's turn, etc.)
- Autism or developmental delays
- Psychotic symptoms or active suicidality
- Active Eating Disorders that raise concerns about morbidity and therefore need to be addressed in an intervention and actively monitored
- Unsteady dosage or recently or impending changes to psychotropic medication(s)
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 |
|---|---|---|
| Improvisation + WellnessTheatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques | Behavioural | Improvisation + Wellness |
| ImprovisationTheatrical improvisation exercises (the theatrical art of performance and storytelling without a script) will be completed in this arm. These exercises will be fairly similar to that from the improvisation + wellness but without the wellness techniques. | Behavioural | Improvisation |
| Social CraftParticipants assigned to the Social Craft group will engage in arts and crafts projects and activities | Behavioural | Social Craft |
Primary outcome
Child Anxiety and Depression (based on Parent Report)
Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Child anxiety and depression will be measured using a parent-report. The Revised Child Anxiety and Depression Scale Parent Report (RCADS-P) is a 47-item measure that assesses parent-report of child anxiety and depressive symptoms. Parents respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS-P has excellent psychometric properties, including high internal consistency and convergent validity. Higher scores indicate higher anxiety/depression symptoms. A T-score is created based on the child's age and gender.
Child Anxiety and Depression (based on youth report)
Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Child anxiety and depression will also be measured using a youth report. The Revised Child Anxiety and Depression Scale (RCADS) is a 47 item measure that assesses child report of child anxiety and depressive symptoms. Youth respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS has been translated from English into Spanish, Chinese, Dutch, and Danish. The measure has good discriminant validity, internal consistency, and convergent validity and discriminates between anxiety and depression.
Cognitive Behavioral Technique (CBT) Skill Knowledge
Time frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
This is a measure designed by the research team that assesses cognitive-behavioral techniques (CBT) Skills knowledge. Participants indicate whether each item is true or false. Items ask about whether thoughts and feelings influence one another, whether avoidance is a good idea when one is anxious about something, present-moment focus/mindfulness, diaphragmatic breathing, activity scheduling, progressive muscle relaxation, etc.
Cognitive Behavioral Technique (CBT) Skills Use
Time frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
This is a measure designed by the research team that assesses cognitive-behavioral technique (CBT) Skills use. Participants indicate how often they use each skill on a scale from Never (0) to At least once a day (5). Skills assessed included diaphragmatic breathing, cognitive restructuring, facing your fears, muscle relaxation, being mindful, scheduling pleasant activities, etc.
4 secondary outcomes
Youth mindfulness
Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Connectedness
Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Emotion regulation
Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group
Self-esteem
Time frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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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.
Amy Przeworski, PhD principal investigator
Case Western Reserve 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 Improvisation + Wellness, Improvisation and Social Craft in people with Anxiety and Depression, run by Case Western Reserve 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Przeworski, PhD (216-368-5021, axp335@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Anxiety and Depression (based on Parent Report) (time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.