NCT03515564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

6.5 years

First QC Date

April 11, 2018

Last Update Submit

January 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • PTSD symptoms (adults)

    8 weeks

  • Depressive symptoms (adults)

    8 weeks

  • Depressive Symptoms (Children)

    8 weeks

  • Anxiety Symptoms (Children)

    8 weeks

  • Somatic Symptoms (adults and children)

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Alternative therapy

EXPERIMENTAL

Dance/Movement Therapy, Art Therapy, Mindful Yoga 60 minutes once weekly for 8 weeks

Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga

No Intervention

NO INTERVENTION

No Intervention

Interventions

Utilizing deep breathing, exercise modalities, and social support in all settings

Alternative therapy

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Adults who are unable or unwilling to consent, or children whose parent do not consent
  • Wardens of the Court

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State U Department of Psychiatry

Detroit, Michigan, 48197, United States

Location

Related Publications (1)

  • Grasser LR, Al-Saghir H, Wanna C, Spinei J, Javanbakht A. Moving Through the Trauma: Dance/Movement Therapy as a Somatic-Based Intervention for Addressing Trauma and Stress Among Syrian Refugee Children. J Am Acad Child Adolesc Psychiatry. 2019 Nov;58(11):1124-1126. doi: 10.1016/j.jaac.2019.07.007. Epub 2019 Jul 23.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersWounds and Injuries

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Arash Javanbakht, MD

    Department of Psychiatry and Behavioral Neuroscience, Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Stress, Trauma, and Anxiety Research Clinic

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 3, 2018

Study Start

July 26, 2017

Primary Completion

January 26, 2024

Study Completion

January 26, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations