Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms (ArtTherapy)
Primary Purpose
Post-Traumatic Headache, PTSD, TBI
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Art Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Headache
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
Sites / Locations
- National Intrepid Center of Excellence at Walter Reed National Military Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
qEEG Art Therapy
Arm Description
Participants will receive art therapy while a noninvasive, mobile qEEG measures brain activity. There is no comparison as this is an exploratory pilot study.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
CAPS-5
Clinician-Administered PTSD Scale for DSM-5
TAS-20
The Toronto Alexithymia Scale
AIQ
Aspects of Identity Questionnaire
PCL-5
Post Traumatic Stress Symptom Questionnaire
GAD-7
General Anxiety Disorder Questionnaire
PHQ-9
Patient Health Questionnaire for depression symptoms
PHQ-15
Patient Health Questionnaire for somatic symptoms
NSI
Neurological Symptom Inventory
PGIC
General Impression of Change
SUD Scores
Subjective Units of Distress
Full Information
NCT ID
NCT04776304
First Posted
April 8, 2020
Last Updated
May 26, 2022
Sponsor
Walter Reed National Military Medical Center
Collaborators
National Intrepid Center of Excellence
1. Study Identification
Unique Protocol Identification Number
NCT04776304
Brief Title
Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms
Acronym
ArtTherapy
Official Title
Evaluation of Quantitative EEG During Art Therapy in Service Members With Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
National Intrepid Center of Excellence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
qEEG Art Therapy
Arm Type
Other
Arm Description
Participants will receive art therapy while a noninvasive, mobile qEEG measures brain activity. There is no comparison as this is an exploratory pilot study.
Intervention Type
Behavioral
Intervention Name(s)
Art Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 1 (Week 2)
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 2 (Week 3)
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 3 (Week 4)
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 4 (Week 5)
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 5 (Week 6)
Title
The primary outcome measure is an analysis of qEEG session data.
Description
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)
Time Frame
during the intervention Session 6 (Week 7)
Secondary Outcome Measure Information:
Title
CAPS-5
Description
Clinician-Administered PTSD Scale for DSM-5
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
TAS-20
Description
The Toronto Alexithymia Scale
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
AIQ
Description
Aspects of Identity Questionnaire
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
PCL-5
Description
Post Traumatic Stress Symptom Questionnaire
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
GAD-7
Description
General Anxiety Disorder Questionnaire
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
PHQ-9
Description
Patient Health Questionnaire for depression symptoms
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
PHQ-15
Description
Patient Health Questionnaire for somatic symptoms
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
NSI
Description
Neurological Symptom Inventory
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
PGIC
Description
General Impression of Change
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Title
SUD Scores
Description
Subjective Units of Distress
Time Frame
baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chandler Rhodes
Phone
3012755762
Email
dha.bethesda.j-11.mbx.nicoe-research-studies@mail.mil
Facility Information:
Facility Name
National Intrepid Center of Excellence at Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandler Rhodes
Phone
301-275-5762
Email
chandler.s.rhodes.civ@mail.mil
12. IPD Sharing Statement
Learn more about this trial
Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms
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