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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • National Intrepid Center of Excellence at Walter Reed National Military Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

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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