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Arts and Movement Therapies for Trauma

Primary Purpose

PTSD, Depression, Anxiety

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance/Movement Therapy, Art Therapy, Mindful Yoga
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

7 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State U Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alternative therapy

No Intervention

Arm Description

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

No Intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
Inflammatory State
measure via saliva or blood
Cortisol
measure via hair

Full Information

First Posted
April 11, 2018
Last Updated
July 12, 2022
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT03515564
Brief Title
Arts and Movement Therapies for Trauma
Official Title
Targeting Trauma-Related Disorders With Arts and Movement Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Anxiety, Stress, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternative therapy
Arm Type
Experimental
Arm Description
Dance/Movement Therapy, Art Therapy, Mindful Yoga 60 minutes once weekly for 8 weeks
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Dance/Movement Therapy, Art Therapy, Mindful Yoga
Intervention Description
Utilizing deep breathing, exercise modalities, and social support in all settings
Primary Outcome Measure Information:
Title
PTSD symptoms (children)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PTSD symptoms (adults)
Description
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.
Time Frame
8 weeks
Title
Depressive symptoms (adults)
Description
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.
Time Frame
8 weeks
Title
Depressive Symptoms (Children)
Description
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.
Time Frame
8 weeks
Title
Anxiety Symptoms (Children)
Description
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.
Time Frame
8 weeks
Title
Somatic Symptoms (adults and children)
Description
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
Time Frame
8 weeks
Title
Inflammatory State
Description
measure via saliva or blood
Time Frame
8 weeks
Title
Cortisol
Description
measure via hair
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Javanbakht, MD
Organizational Affiliation
Department of Psychiatry and Behavioral Neuroscience, Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State U Department of Psychiatry
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31348987
Citation
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.
Results Reference
derived

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Arts and Movement Therapies for Trauma

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