Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms

PTSD Clinical Trial

— ArtTherapy  

Official title:

Evaluation of Quantitative EEG During Art Therapy in Service Members With Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776304
• Other study ID #: WRNMMC-2020-0279
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: Walter Reed National Military Medical Center
• Contact: Chandler Rhodes
• Phone: 3012755762
• Email: dha.bethesda.j-11.mbx.nicoe-research-studies[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Anger
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Combat and Operational Stress Reaction
• Combat Disorders
• Combat Stress Disorders
• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Fractures, Stress
• Headache
• Irritable Mood
• Military Activity
• Military Family
• Military Operations
• MTBI - Mild Traumatic Brain Injury
• Nightmare
• Nightmares, REM-Sleep Type
• Post-Traumatic Headache
• Posttraumatic Stress Disorder
• Posttraumatic Stress Disorder, Delayed Onset
• PTSD
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• TBI
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Behavioral:
• Art Therapy
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.

Locations

Country	Name	City	State
United States	National Intrepid Center of Excellence at Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	National Intrepid Center of Excellence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is an analysis of qEEG session data.	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)
Primary	The primary outcome measure is an analysis of qEEG session data.	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)
Primary	The primary outcome measure is an analysis of qEEG session data.	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)
Primary	The primary outcome measure is an analysis of qEEG session data.	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)
Primary	The primary outcome measure is an analysis of qEEG session data.	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)
Primary	The primary outcome measure is an analysis of qEEG session data.	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	CAPS-5	Clinician-Administered PTSD Scale for DSM-5	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	TAS-20	The Toronto Alexithymia Scale	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	AIQ	Aspects of Identity Questionnaire	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	PCL-5	Post Traumatic Stress Symptom Questionnaire	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	GAD-7	General Anxiety Disorder Questionnaire	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	PHQ-9	Patient Health Questionnaire for depression symptoms	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	PHQ-15	Patient Health Questionnaire for somatic symptoms	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	NSI	Neurological Symptom Inventory	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	PGIC	General Impression of Change	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Secondary	SUD Scores	Subjective Units of Distress	baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks