Post-Traumatic HeadacheArtTherapyNCT04776304
Art Therapy QEEG Study for Service Members with a Traumatic Brain Injury and Posttraumatic Stress Symptoms
A study testing Art Therapy in people with Post-Traumatic Headache and PTSD, run by Walter Reed National Military Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Post-Traumatic Headache, PTSD, TBI
- What is being tested?
- Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2021to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Intrepid Center of Excellence at Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Traumatic Headache, PTSD, TBI, TBI (Traumatic Brain Injury), MTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
- Being tested
- Art Therapy
- Medical subject headings
- Post-Traumatic Headache, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Brain Concussion, Parasomnias, Headache, Feeding and Eating Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: during the intervention Session 6 (Week 7)
Secondary outcomes (10)
CAPS-5
Clinician-Administered PTSD Scale for DSM-5
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
TAS-20
The Toronto Alexithymia Scale
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
AIQ
Aspects of Identity Questionnaire
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
PCL-5
Post Traumatic Stress Symptom Questionnaire
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
GAD-7
General Anxiety Disorder Questionnaire
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
PHQ-9
Patient Health Questionnaire for depression symptoms
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
PHQ-15
Patient Health Questionnaire for somatic symptoms
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
NSI
Neurological Symptom Inventory
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
PGIC
General Impression of Change
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
SUD Scores
Subjective Units of Distress
Measured: baseline (pre-intervention) and immediately after the intervention; within a period of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start30 Oct 2021
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Intrepid Center of Excellence
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776304
- Sponsor's protocol ID
- WRNMMC-2020-0279
- Acronym
- ArtTherapy
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quantitative EEG During Art Therapy in Service Members with Co-Morbid Traumatic Brain Injury & Posttraumatic Stress Symptoms
- ClinicalTrials.gov ID
- NCT04776304
- Acronym / sponsor ID
- ArtTherapy / WRNMMC-2020-0279
- Conditions
- Post-Traumatic Headache, PTSD, TBI, TBI (Traumatic Brain Injury), MTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- National Intrepid Center of Excellence
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is both interventional, meaning SMs receive art therapy, and analytical, to understand qEEG outcomes.
| Arm | Type | Receives |
|---|---|---|
| qEEG Art Therapy | Other | Behavioral: Art TherapyParticipants will receive art therapy while a noninvasive, mobile qEEG measures brain activity. There is no comparison as this is an exploratory pilot study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyThis 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. | Behavioural | qEEG Art Therapy |
Primary outcome
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)
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)
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)
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)
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)
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)
10 secondary outcomes
CAPS-5
Time frame: 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
AIQ
Time frame: 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
GAD-7
Time frame: 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
PHQ-15
Time frame: 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
PGIC
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Post-Traumatic Headache and PTSD, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is an analysis of qEEG session data. (time frame: during the intervention Session 1 (Week 2)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.