Clinical trial NCT05414708: Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Official title: Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Military Activity
Post-Traumatic Headache
Posttraumatic Stress Disorder
Posttraumatic Stress Disorder, Delayed Onset
Sleep Disturbance
Nightmare
Irritable Mood
Anger
Combat and Operational Stress Reaction
Combat Stress Disorders
Military Family
Military Operations
Keywords: PTSD
Military
Art Therapy
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2022-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend ten sessions over a period of twelve weeks. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The middle eight sessions will be one-hour art therapy sessions with a certified art therapist. The last session will consist of the same self-assessment questionnaires and another MRI scan.

Detailed description: Art Therapy is used across the Military Health System (MHS) as part of interdisciplinary treatment programs with great success, but there is limited research on how this art therapy works. Therefore, the purpose of this research is to learn about the effects of art therapy on emotional expression and regulation in service members as well as the impact of art therapy on brain systems. If a participant chooses to be in this study he or she will attend ten sessions over a period of ten to twelve weeks. The first session and tenth sessions of this research study will include interviews and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and a magnetic resonance imaging (MRI) scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. These sessions will be about 2.5 to 3 hours. The sessions two through nine will include a one-hour art therapy sessions with a certified art therapist. The art therapy sessions are also considered research interventions.

There is the risk that participants may experience increased psychological or emotional distress or frustration when discussing traumatic events during either the art research intervention sessions or during the questionnaires or interviews. Participants may experience a reduction in symptoms associated with posttraumatic stress (PTS), mild traumatic brain injury (mTBI), and/or other psychological heath disorders through the art therapy process. However, there is no guarantee that participants will benefit from being in this research. As an alternative to this research, participants can talk to your physician about art therapy or other therapeutic options.

Eligibility criteria: Inclusion Criteria:

* DEERS Eligible
* Active Duty or Veteran separated within the past 5 years
* Significant posttraumatic stress symptoms (score of \>/=31 on the PCL-5)

Exclusion Criteria:

* History of moderate, severe, or penetrating brain injury
* History of psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
* History of multiple sclerosis, Huntington's disease, or Alzheimer's disease
* History of stroke or myocardial infarction
* History of brain tumor
* History of seizures
* Contradictions for MRI (for example, participants will be excluded for pregnancy, metal implants or suspected shrapnel, aneurysm/intracranial clips, cardiac pacemakers or implanted programmable devices or pumps)
* Unable to provide informed consent
* History of previous exposure to art therapy
* Active substance use disorder

Primary outcomes:
measure: The Primary Outcome Measure is analysis of functional neuroimaging metrics
timeFrame: Week 1
measure: The Primary Outcome Measure is analysis of functional neuroimaging metrics
timeFrame: Week 10
Secondary outcomes:
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Week 1
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Week 10
measure: PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
timeFrame: Week 1
measure: PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
timeFrame: Week 10
measure: Neurobehavioral Symptoms Inventory (NSI)
timeFrame: Week 1
measure: Neurobehavioral Symptoms Inventory (NSI)
timeFrame: Week 10
measure: General Self Efficacy Scale (GSES)
timeFrame: Week 1
measure: General Self Efficacy Scale (GSES)
timeFrame: Week 10
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Week 1
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Week 10
measure: Self-Regulation Questionnaire (SRQ)
timeFrame: Week 1
measure: Self-Regulation Questionnaire (SRQ)
timeFrame: Week 10
measure: Perceived Stress Scale (PSS)
timeFrame: Week 1
measure: Perceived Stress Scale (PSS)
timeFrame: Week 10
measure: Revised Helping Alliance Questionnaire (HAQ-II)
timeFrame: Week 10
measure: Moral Injury Events Scale (MIES)
timeFrame: Week 1
measure: Moral Injury Events Scale (MIES)
timeFrame: Week 10
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Intrepid Center of Excellence
state: Maryland
Study officials:
affiliation: WRNMMC
name: Chandler Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References: