PTSDNCT03515564
Arts and Movement Therapies for Trauma
A study testing Dance/Movement Therapy, Art Therapy, Mindful Yoga in people with PTSD and Depression, run by Wayne State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- PTSD, Depression, Anxiety
- What is being tested?
- Dance/Movement Therapy, Art Therapy, Mindful Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adults who are unable or unwilling to consent, or children whose parent do not consent
- Wardens of the Court
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State U Department of Psychiatry
Detroit, Michigan, 48197
About this study
Official title: 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.
- Conditions
- PTSD, Depression, Anxiety, Stress, Trauma
- Being tested
- Dance/Movement Therapy, Art Therapy, Mindful Yoga
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance/Movement Therapy, Art Therapy, Mindful YogaBehavioural
Utilizing deep breathing, exercise modalities, and social support in all settings
| Study group | Role | What they receive |
|---|---|---|
| Alternative therapy | Experimental | Dance/Movement Therapy, Art Therapy, Mindful Yoga
60 minutes once weekly for 8 weeks Receives: Behavioral: Dance/Movement Therapy, Art Therapy, Mindful Yoga |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
Inflammatory State
measure via saliva or blood
Measured: 8 weeks
Cortisol
measure via hair
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start26 Jul 2017
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arash Javanbakht, Wayne State University
- Investigators
- Arash Javanbakht, MD, Principal investigator, Department of Psychiatry and Behavioral Neuroscience, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515564
- Sponsor's protocol ID
- 1706000635
- Status last verified
- Jan 2024
- First submitted
- 11 Apr 2018
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31348987
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Trauma-Related Disorders With Arts and Movement Therapies
- ClinicalTrials.gov ID
- NCT03515564
- Acronym / sponsor ID
- 1706000635
- Conditions
- PTSD, Depression, Anxiety, Stress, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative therapy | Experimental | Behavioral: Dance/Movement Therapy, Art Therapy, Mindful YogaDance/Movement Therapy, Art Therapy, Mindful Yoga 60 minutes once weekly for 8 weeks |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Adults who are unable or unwilling to consent, or children whose parent do not consent
- Wardens of the Court
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance/Movement Therapy, Art Therapy, Mindful YogaUtilizing deep breathing, exercise modalities, and social support in all settings | Behavioural | Alternative therapy |
Primary outcome
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.
7 secondary outcomes
PTSD symptoms (adults)
Time frame: 8 weeks
Depressive symptoms (adults)
Time frame: 8 weeks
Depressive Symptoms (Children)
Time frame: 8 weeks
Anxiety Symptoms (Children)
Time frame: 8 weeks
Somatic Symptoms (adults and children)
Time frame: 8 weeks
Inflammatory State
Time frame: 8 weeks
Cortisol
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 31348987Grasser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Javanbakht, MD principal investigator
Department of Psychiatry and Behavioral Neuroscience, Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance/Movement Therapy, Art Therapy, Mindful Yoga in people with PTSD and Depression, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (children) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.