Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 2:14 PM
Study NCT ID:
NCT04776304
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Art Therapy QEEG Study for Service Members with a Traumatic Brain Injury and Posttraumatic Stress Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D003130', 'term': 'Combat Disorders'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001155', 'term': 'Art Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 1 (Week 2)', '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)'}, {'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 2 (Week 3)', '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)'}, {'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 3 (Week 4)', '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)'}, {'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 4 (Week 5)', '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)'}, {'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 5 (Week 6)', '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)'}, {'measure': 'The primary outcome measure is an analysis of qEEG session data.', 'timeFrame': 'during the intervention Session 6 (Week 7)', '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)'}], 'secondaryOutcomes': [{'measure': 'CAPS-5', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Clinician-Administered PTSD Scale for DSM-5'}, {'measure': 'TAS-20', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'The Toronto Alexithymia Scale'}, {'measure': 'AIQ', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Aspects of Identity Questionnaire'}, {'measure': 'PCL-5', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Post Traumatic Stress Symptom Questionnaire'}, {'measure': 'GAD-7', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'General Anxiety Disorder Questionnaire'}, {'measure': 'PHQ-9', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Patient Health Questionnaire for depression symptoms'}, {'measure': 'PHQ-15', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Patient Health Questionnaire for somatic symptoms'}, {'measure': 'NSI', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Neurological Symptom Inventory'}, {'measure': 'PGIC', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'General Impression of Change'}, {'measure': 'SUD Scores', 'timeFrame': 'baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks', 'description': 'Subjective Units of Distress'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBackground: 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active duty service member or recently separated veteran (within the past 5 years)\n* DEERs eligible\n* Significant posttraumatic stress symptoms\n* History of mild traumatic brain injury\n* Aged 18-64\n\nExclusion Criteria:\n\n* Previous art therapy exposure\n* Moderate, severe, or penetrating TBI history\n* History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04776304', 'acronym': 'ArtTherapy', 'briefTitle': 'Art Therapy QEEG Study for Service Members with a Traumatic Brain Injury and Posttraumatic Stress Symptoms', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Evaluation of Quantitative EEG During Art Therapy in Service Members with Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms', 'orgStudyIdInfo': {'id': 'WRNMMC-2020-0279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'qEEG Art Therapy', '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.', 'interventionNames': ['Behavioral: Art Therapy']}], 'interventions': [{'name': 'Art Therapy', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['qEEG Art Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Intrepid Center of Excellence at Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'National Intrepid Center of Excellence', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}