Arts and Movement Therapies for Trauma

Depression Clinical Trial

Official title:

Targeting Trauma-Related Disorders With Arts and Movement Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515564
• Other study ID #: 1706000635
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: January 26, 2024

Study information

• Verified date: January 2024
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current goal of this project is to subjectively and objectively assess the efficacy of arts and movement interventions--including dance/movement therapy, art therapy and mindful yoga for youth and adults exposed to trauma, including families resettled as refugees and families in high-risk, low-resource environments. The overarching aim is to measure the changes over time in self-reported symptoms of posttraumatic stress disorder, anxiety disorder(s), depression, and somatic symptoms, as well as changes in biological substrates representing pathophysiological processes involved in responses to stress, trauma, and the aforementioned disorders. These biological substrates include inflammatory proteins and the stress hormone cortisol. We hypothesize that given the emotional and physical components of arts and movement therapies, which are implemented in group settings and confer life-long coping skills to participants, participation in arts and movement therapies will result in reduction of self-reported severity of psyciatric symptoms and improved physiology.

COVID-19: In March, the COVID-19 pandemic caused in person research to be halted in order to be in adherence to the stay at home order for the State of Michigan. The IRB overseeing the present project approved an amendment to allow data to be collected online via phone or email, based on participant preference, with a new consent form for this new method of data collection. Following this approval, we migrated our programming to virtual formats and began to serve both refugee commuities as well as school-aged youth with the intervention program and obtained consent followed by data from participants as part of this study. We have pivoted towards also looking at the benefits of creative arts and movement based interventions in reducing COVID-related distress, as well as building resilience.

By collecting psychological and biomarker data the investigators seek concrete scientific evidence supporting these non-pharmacological, cost effective, and accessible programs as reliable treatment options.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female children and adults ages 7-65

• Willing and able to consent, or with at least one parent willing and able to provide consent for minors under age 18

Exclusion Criteria:

• Adults who are unable or unwilling to consent, or children whose parent do not consent

• Wardens of the Court

Related Conditions & MeSH terms

• Anxiety
• Depression
• PTSD
• Stress
• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Dance/Movement Therapy, Art Therapy, Mindful Yoga
Utilizing deep breathing, exercise modalities, and social support in all settings

Locations

Country	Name	City	State
United States	Wayne State U Department of Psychiatry	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms (children)	Evaluation of PTSD related symptoms. UCLA Trauma Questionnaire administered to children. 33 items ranked from 0-4, with 0 = none of the time to 4 = most of the time. Scores can be summed for a composite score, with a maximum of 132 and a minimum of 0, or determination of PTSD criteria met utilizing responses to individual questions.	8 weeks
Secondary	PTSD symptoms (adults)	PCL-c for DSM V (Post-traumatic stress disorder checklist for civilians). 20 questions ranked from 0 to 4 for "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." Maximum score = 80, minimum score = 0. A score of 33 or higher appears reasonable to propose possible PTSD. Diagnostic criteria can also be evaluated by assessing responses to individual questions.	8 weeks
Secondary	Depressive symptoms (adults)	Hopkins Symptoms Checklist - 25. Evaluates depressive and anxiety related symptoms in adults. Responses: ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively. Anxiety score is the average of the first ten questions; depressive score is the average of the last 15 questions. For either measure, scores greater than 1.75 are said to be symptomatic. Highest score = 4; lowest score = 0.	8 weeks
Secondary	Depressive Symptoms (Children)	Mood and Feelings Questionnaire (long form). 33 questions to assess depressive symptoms, ranked from 0 to 2. Highest score = 66 and lowest = 0; score of 27 or higher is said to be indicative of possible depression. 0 = not true, 1 = sometimes true, and 2 = true.	8 weeks
Secondary	Anxiety Symptoms (Children)	Screen for Child Anxiety Related Emotional Disorders. 41 item questionnaire. 'Not True or Hardly Ever True' (Score 0), 'Somewhat True or Sometimes True' (Score 1), or 'Very True or Often True' (Score 2). Maximum score = 82; minimum score = 0. Scores are summed.	8 weeks
Secondary	Somatic Symptoms (adults and children)	Somatic symptoms scale, 8 items. Ranks somatic symptoms on a scale from 0 to 4, with the following possible scoring results: no to minimal (0-3 points), low (4-7 points), medium (8-11 points), high (12-15 points), and very high (16-32 points) somatic symptom burden	8 weeks
Secondary	Inflammatory State	measure via saliva or blood	8 weeks
Secondary	Cortisol	measure via hair	8 weeks