Clinical trial NCT04776304: Art Therapy QEEG Study for Service Members with a Traumatic Brain Injury and Posttraumatic Stress Symptoms
Official title: Evaluation of Quantitative EEG During Art Therapy in Service Members with Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Headache
PTSD
TBI
TBI (Traumatic Brain Injury)
MTBI - Mild Traumatic Brain Injury
Posttraumatic Stress Disorder
Posttraumatic Stress Disorder, Delayed Onset
Sleep Disturbance
Nightmare
Nightmares, REM-Sleep Type
Headache
Irritable Mood
Anger
Eating Disorders
Combat and Operational Stress Reaction
Combat Stress Disorders
Military Operations
Military Activity
Military Family
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: National Intrepid Center of Excellence
First posted: 2021-03-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.
Primary purpose: TREATMENT

Brief summary: Service members and/or recently separated veterans with post traumatic stress symptoms and mild traumatic brain injury may participate in 8 sessions including 2 sessions including interviews and questionnaires as well as 6 sessions of art therapy. In the art therapy, 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 a mobile qEEG (worn like a hat and backpack). The qEEG will measure brain activity in a non-invasive way throughout the art therapy session to improve understanding of brain activity during the art therapy process.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 1 (Week 2)
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 2 (Week 3)
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 3 (Week 4)
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 4 (Week 5)
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 5 (Week 6)
measure: The primary outcome measure is an analysis of qEEG session data.
timeFrame: during the intervention Session 6 (Week 7)
Secondary outcomes:
measure: CAPS-5
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: TAS-20
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: AIQ
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: PCL-5
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: GAD-7
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: PHQ-9
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: PHQ-15
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: NSI
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: PGIC
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
measure: SUD Scores
timeFrame: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Intrepid Center of Excellence at Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: