Recruiting

CBT & Improvisation

Sponsor:

Case Western Reserve University

Code:

NCT07033052

Conditions

Anxiety

Depression

Mood

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Improvisation + Wellness

Improvisation

Social Craft

Study Details

Brief 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. 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.

Conditions

Anxiety

Depression

Mood

Study ID

NCT07033052

Start date

Apr 15, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between 8 and 17 years of age
  • Individuals must have parental/guardian consent
  • Elevated levels of anxiety or depression based on

1. Screen for Child Anxiety Related Disorders (SCARED) score of 15 or higher, or;
2. Revised Children's Anxiety and Depression Scale (RCADS) Depression T score of 65 or higher, or;
3. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinician severity rating of 3 on any anxiety disorder or on a mood-related disorder

Exclusion Criteria:

  • 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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Improvisation + Wellness

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).

experimental: Improvisation

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).

active comparator: Social Craft

The social craft group involves youth connecting with other youth while completing craft projects.

Interventions

Improvisation + Wellness

Theatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques

Improvisation

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 Craft

Participants assigned to the Social Craft group will engage in arts and crafts projects and activities

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 ]
  • Child Anxiety and Depression (based on youth report) [ Time Frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group ]
  • Cognitive Behavioral Technique (CBT) Skill Knowledge [ Time Frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group ]
  • Cognitive Behavioral Technique (CBT) Skills Use [ Time Frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group ]

Central Contacts and Locations

Central contacts

Amy Przeworski, PhD

216-368-5021axp335@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Amy Przeworski, PhD

216-368-5022soarlab@case.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-07-31.