- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776304
Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms (ArtTherapy)
Evaluation of Quantitative EEG During Art Therapy in Service Members With Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms
Study Overview
Status
Conditions
- Anger
- PTSD
- TBI (Traumatic Brain Injury)
- Sleep Disturbance
- Headache
- Posttraumatic Stress Disorder
- Combat Stress Disorders
- Eating Disorders
- Nightmare
- Post-Traumatic Headache
- TBI
- Military Activity
- Posttraumatic Stress Disorder, Delayed Onset
- Irritable Mood
- Combat and Operational Stress Reaction
- Military Family
- Military Operations
- MTBI - Mild Traumatic Brain Injury
- Nightmares, REM-Sleep Type
Intervention / Treatment
Detailed Description
This is a pilot, interventional clinical trial in which all 9 service members with comorbid PTSD and mTBI participate in 8 sessions (1 baseline session of interviews and questionnaires, 6 sessions of art therapy, and 1 final session of interviews and questionnaires). Participants must have significant posttraumatic stress symptoms and a history of mild traumatic brain injury. Target enrollment is 9 active duty service members or recently separated veterans, aged 18-64 with no prior art therapy exposure, at the NICoE at Walter Reed National Military Medical Center in Bethesda, MD.
Background: Posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are persistent and frequently comorbid complications of combat that remain a challenge to healthcare providers. In these complex cases, traditional treatments often fail to provide complete relief from symptoms associated with posttraumatic stress (PTS), anxiety, and depression, leading the military healthcare system to look towards complementary and integrative treatments. Art therapy is one promising intervention that helps service members (SMs) develop a "visual voice," using imagery, symbolism, and metaphor to externalize emotions and experiences that they may not be able to express in words. The standardized, integrative mental health and human services approach of the art therapy program at the NICoE utilizes a mask-making directive to explore thoughts, feelings, and experiences of combat and self-understanding. This process is especially relevant to SMs with PTS symptoms who often remember their trauma as an incoherent, fragmented memory that is often predominantly sensory in nature. NICoE researchers have provided preliminary evidence suggesting associations between recurring art themes represented within the masks and individual BH symptoms; yet, the neurobiological mechanisms underlying this therapeutic technique remain obscure. To date, there have been few studies using neuroimaging techniques to investigate brain network changes during art creation. Studies have utilized electroencephalography (EEG) and functional near infrared spectroscopy (fNIRS) during art creation but not within the context of art therapy. Mobile, quantitative EEG allows for real time data capture that could minimize interference of neuroimaging during the therapeutic process and provide insight into the neurological mechanisms underlying art therapy.
Study design and procedures: Participants will be provided with a blank paper mache mask template and invited to alter the mask however they wish using a variety of art materials. The therapist will use the art-making process and culminating product to aid in self-reflection, reframe negative thoughts and feelings, and work through traumatic content. Prior to the session start participants will get set up with the mobile qEEG. The qEEG will be segmented into a pre-art therapy session resting state, prompt-specific tasks during the art therapy session, and a post-art therapy session resting state.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chandler Rhodes
- Phone Number: 3012755762
- Email: dha.bethesda.j-11.mbx.nicoe-research-studies@mail.mil
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20814
- Recruiting
- National Intrepid Center of Excellence at Walter Reed National Military Medical Center
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Contact:
- Chandler Rhodes
- Phone Number: 301-275-5762
- Email: chandler.s.rhodes.civ@mail.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active duty service member or recently separated veteran (within the past 5 years)
- DEERs eligible
- Significant posttraumatic stress symptoms
- History of mild traumatic brain injury
- Aged 18-64
Exclusion Criteria:
- Previous art therapy exposure
- Moderate, severe, or penetrating TBI history
- History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
- Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: qEEG Art Therapy
Participants will receive art therapy while a noninvasive, mobile qEEG measures brain activity.
There is no comparison as this is an exploratory pilot study.
|
This is a pilot study in which every participant receives the art therapy intervention arm.
There are no waitlist or control arms.
Art therapy is one promising intervention that helps service members (SMs) develop a "visual voice," using imagery, symbolism, and metaphor to externalize emotions and experiences that they may not be able to express in words.
The standardized, integrative mental health and human services approach of the art therapy program at the NICoE utilizes a mask-making directive to explore thoughts, feelings, and experiences of combat and self-understanding.
This process is especially relevant to SMs with PTS symptoms who often remember their trauma as an incoherent, fragmented memory that is often predominantly sensory in nature.
NICoE researchers have provided preliminary evidence suggesting associations between recurring art themes represented within the masks and individual BH symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 1 (Week 2)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.
Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 1 (Week 2)
|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 2 (Week 3)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.
Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 2 (Week 3)
|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 3 (Week 4)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 3 (Week 4)
|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 4 (Week 5)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.
Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 4 (Week 5)
|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 5 (Week 6)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.
Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 5 (Week 6)
|
The primary outcome measure is an analysis of qEEG session data.
Time Frame: during the intervention Session 6 (Week 7)
|
The primary outcome measure is an analysis of qEEG session data, which will include regional and global power across the following frequency bands: delta (1-4 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (13- 30 Hz), and gamma (>30 Hz); global interhemispheric coherence; and regional coherence between pairs of sensor locations.
Global/regional power (units: micro-Volts-squared per Hz (uV2/Hz) Interhemispheric coherence (units coherence) Regional coherence (units coherence)
|
during the intervention Session 6 (Week 7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAPS-5
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Clinician-Administered PTSD Scale for DSM-5
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
TAS-20
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
The Toronto Alexithymia Scale
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
AIQ
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Aspects of Identity Questionnaire
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
PCL-5
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Post Traumatic Stress Symptom Questionnaire
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
GAD-7
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
General Anxiety Disorder Questionnaire
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
PHQ-9
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Patient Health Questionnaire for depression symptoms
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
PHQ-15
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Patient Health Questionnaire for somatic symptoms
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
NSI
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Neurological Symptom Inventory
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
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PGIC
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
General Impression of Change
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
SUD Scores
Time Frame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Subjective Units of Distress
|
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Fractures, Bone
- Craniocerebral Trauma
- Trauma, Nervous System
- Trauma and Stressor Related Disorders
- Headache Disorders
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Headache Disorders, Secondary
- Disease
- Brain Injuries
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Wounds and Injuries
- Feeding and Eating Disorders
- Brain Injuries, Traumatic
- Headache
- Fractures, Stress
- Combat Disorders
- Brain Concussion
- Post-Traumatic Headache
Other Study ID Numbers
- WRNMMC-2020-0279
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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