- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515564
Arts and Movement Therapies for Trauma
Targeting Trauma-Related Disorders With Arts and Movement Therapies
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48197
- Wayne State U Department of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
|
|
|
Experimental: Alternative therapy
Dance/Movement Therapy, Art Therapy, Mindful Yoga 60 minutes once weekly for 8 weeks |
Utilizing deep breathing, exercise modalities, and social support in all settings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptoms (children)
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptoms (adults)
Time Frame: 8 weeks
|
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
|
|
Depressive symptoms (adults)
Time Frame: 8 weeks
|
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
|
|
Depressive Symptoms (Children)
Time Frame: 8 weeks
|
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
|
|
Anxiety Symptoms (Children)
Time Frame: 8 weeks
|
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
|
|
Somatic Symptoms (adults and children)
Time Frame: 8 weeks
|
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
|
|
Inflammatory State
Time Frame: 8 weeks
|
measure via saliva or blood
|
8 weeks
|
|
Cortisol
Time Frame: 8 weeks
|
measure via hair
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arash Javanbakht, MD, Department of Psychiatry and Behavioral Neuroscience, Wayne State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1706000635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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