Art Therapy QEEG Study for Service Members with a Traumatic Brain Injury and Posttraumatic Stress Symptoms

NCT04776304 | Completed

• 1 other identifier: WRNMMC-2020-0279
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (10)

• CAPS-5

  baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks

• TAS-20

  baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks

• AIQ

  baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks

• PCL-5

  baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks

• GAD-7

  baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks

Study Arms (1)

qEEG Art Therapy

OTHER

Participants will receive art therapy while a noninvasive, mobile qEEG measures brain activity. There is no comparison as this is an exploratory pilot study.

Behavioral: Art Therapy

Interventions

Art Therapy BEHAVIORAL

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.

qEEG Art Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• National Intrepid Center of Excellence: collaborator

Study Sites (1)

National Intrepid Center of Excellence at Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Brain Concussion; Parasomnias; Headache; Feeding and Eating Disorders; Combat Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Sleep Wake Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: March 1, 2021
• Study Start: October 30, 2021
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)