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Recruiting NCT05414708

Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms

No phase Interventional PTSD Military Activity Post-Traumatic Headache Posttraumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Art Therapy.
Who it may be relevant to
Registry conditions: PTSD, Military Activity, Post-Traumatic Headache, Posttraumatic Stress Disorder. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 eleven sessions over a period of six to eight months. 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 following eight sessions will be one-hour art therapy sessions with a certified art therapist. The tenth session will consist of the same self-assessment questionnaires and another MRI scan. The final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.

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 eleven sessions over a period of six to eight months. 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. The eleventh and final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.

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.

Interventions

  • Behavioral Art Therapy
    During the art research intervention session, the art therapist will walk you through the creation of various types of art and may spend time asking you about the artwork, how you are felling, as well as your past experiences.

Primary outcome measures

  • The Primary Outcome Measure is analysis of functional neuroimaging metrics [Time frame: Baseline]
  • The Primary Outcome Measure is analysis of functional neuroimaging metrics [Time frame: Through study completion, an average of 14 weeks]
Secondary outcome measures (12)
  • Toronto Alexithymia Scale (TAS-20) [Time frame: Baseline]
  • Toronto Alexithymia Scale (TAS-20) [Time frame: Through study completion, an average of 14 weeks]
  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5) [Time frame: Baseline]
  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5) [Time frame: Through study completion, an average of 14 weeks]
  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5) [Time frame: Study completion, an average of six to eight months]
  • Neurobehavioral Symptoms Inventory (NSI) [Time frame: Baseline]
  • Neurobehavioral Symptoms Inventory (NSI) [Time frame: Through study completion, an average of 14 weeks]
  • Neurobehavioral Symptoms Inventory (NSI) [Time frame: Study completion, an average of six to eight months]
  • General Self Efficacy Scale (GSES) [Time frame: Baseline]
  • General Self Efficacy Scale (GSES) [Time frame: Through study completion, an average of 14 weeks]
  • General Self Efficacy Scale (GSES) [Time frame: Study completion, an average of six to eight months]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • DEERS Eligible
  • Active Duty or Veteran separated within the past 10 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • National Intrepid Center of Excellence — Bethesda
  • ISC at Fort Belvoir — Fort Belvoir

Identifiers

NCT: NCT05414708 · 2021-13476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗