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NCT Number: NCT05414708

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

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.

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Key information

Conditions

PTSD Anger Behavior Brain Diseases Central Nervous System Diseases Combat Disorders Combat Stress Disorders Combat and Operational Stress Reaction Emotion Processing Emotional Regulation Headache Disorders Headache Disorders, Secondary Irritable Mood Mental Disorders Military Activity Military Family Military Operations Nervous System Diseases Nightmare Parasomnias Post-Traumatic Headache Posttraumatic Stress Disorder Posttraumatic Stress Disorder, Delayed Onset Self-Control Sleep Disturbance Sleep Wake Disorders Social Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Intrepid Center of Excellence, Bethesda, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art Therapy

Behavioral

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 outcomes

  1. The Primary Outcome Measure is analysis of functional neuroimaging metrics

    Time frame: Baseline

    The primary outcome measure is the analysis of resting state and task based functional MRI data which include but functional connectivity measures between brain regions at rest and during the task as well as functional activation patterns during the task.

    MRI and a series of task based fMRI sequences.

  2. The Primary Outcome Measure is analysis of functional neuroimaging metrics

    Time frame: Through study completion, an average of 14 weeks

    The primary outcome measure is the analysis of resting state and task based functional MRI data which include but functional connectivity measures between brain regions at rest and during the task as well as functional activation patterns during the task.

    MRI and a series of task based fMRI sequences.

Secondary outcomes

  1. Toronto Alexithymia Scale (TAS-20)

    Time frame: Baseline

    A 20-item instrument that measures alexithymia defined as trouble identifying and describing emotions. A 20-item instrument that measures alexithymia defined as trouble identifying and describing emotions. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree.

  2. Toronto Alexithymia Scale (TAS-20)

    Time frame: Through study completion, an average of 14 weeks

    A 20-item instrument that measures alexithymia defined as trouble identifying and describing emotions. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree.

  3. PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Time frame: Baseline

    A 20-item self-report measure of the 20 DSM-5 symptoms of PTSD. Respondents rate how much they were "bothered by that problem in the past month". Items are rated on a scale ranging from 0 ("not at all") to 4 ("extremely")

  4. PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Time frame: Through study completion, an average of 14 weeks

    A 20-item self-report measure of the 20 DSM-5 symptoms of PTSD. Respondents rate how much they were "bothered by that problem in the past month". Items are rated on a scale ranging from 0 ("not at all") to 4 ("extremely")

  5. PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Time frame: Study completion, an average of six to eight months

    A 20-item self-report measure of the 20 DSM-5 symptoms of PTSD. Respondents rate how much they were "bothered by that problem in the past month". Items are rated on a scale ranging from 0 ("not at all") to 4 ("extremely")

  6. Neurobehavioral Symptoms Inventory (NSI)

    Time frame: Baseline

    A self-reported questionnaire that measures common post concussive symptoms. The severity of each symptom as experienced in the last two weeks is rated on a scale (0) none to (4) very severe

  7. Neurobehavioral Symptoms Inventory (NSI)

    Time frame: Through study completion, an average of 14 weeks

    A self-reported questionnaire that measures common post concussive symptoms. The severity of each symptom as experienced in the last two weeks is rated on a scale (0) none to (4) very severe

  8. Neurobehavioral Symptoms Inventory (NSI)

    Time frame: Study completion, an average of six to eight months

    A self-reported questionnaire that measures common post concussive symptoms. The severity of each symptom as experienced in the last two weeks is rated on a scale (0) none to (4) very severe

  9. General Self Efficacy Scale (GSES)

    Time frame: Baseline

    A self-report questionnaire that predicts coping with and adapting to stressful life event. The extent to which the participant agrees with each statement is measured on a scale of 1 (not true at all) to 4 (exactly true).

  10. General Self Efficacy Scale (GSES)

    Time frame: Through study completion, an average of 14 weeks

    A self-report questionnaire that predicts coping with and adapting to stressful life event. The extent to which the participant agrees with each statement is measured on a scale of 1 (not true at all) to 4 (exactly true).

  11. General Self Efficacy Scale (GSES)

    Time frame: Study completion, an average of six to eight months

    A self-report questionnaire that predicts coping with and adapting to stressful life event. The extent to which the participant agrees with each statement is measured on a scale of 1 (not true at all) to 4 (exactly true).

  12. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

    A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater

  13. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Through study completion, an average of 14 weeks

    A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater

  14. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Study completion, an average of six to eight months

    A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater

  15. Self-Regulation Questionnaire (SRQ)

    Time frame: Baseline

    A self-report questionnaire that measures the ability to develop, implement, and flexibly maintain planned behavior. The extent to which the participant agrees with each statement is rated on a scale of 1 (strongly disagree) to 5 (strongly agree).

  16. Self-Regulation Questionnaire (SRQ)

    Time frame: Through study completion, an average of 14 weeks

    A self-report questionnaire that measures the ability to develop, implement, and flexibly maintain planned behavior. The extent to which the participant agrees with each statement is rated on a scale of 1 (strongly disagree) to 5 (strongly agree).

  17. Self-Regulation Questionnaire (SRQ)

    Time frame: Study completion, an average of six to eight months

    A self-report questionnaire that measures the ability to develop, implement, and flexibly maintain planned behavior. The extent to which the participant agrees with each statement is rated on a scale of 1 (strongly disagree) to 5 (strongly agree).

  18. Perceived Stress Scale (PSS)

    Time frame: Baseline

    A self-report questionnaire that measures the level of perceived stress for a participant. How often the participant experiences each event is rated on a scale of 0 (never) to 4 (very often).

  19. Perceived Stress Scale (PSS)

    Time frame: Through study completion, an average of 14 weeks

    A self-report questionnaire that measures the level of perceived stress for a participant. How often the participant experiences each event is rated on a scale of 0 (never) to 4 (very often).

  20. Perceived Stress Scale (PSS)

    Time frame: Study completion, an average of six to eight months

    A self-report questionnaire that measures the level of perceived stress for a participant. How often the participant experiences each event is rated on a scale of 0 (never) to 4 (very often).

  21. Revised Helping Alliance Questionnaire (HAQ-II)

    Time frame: Through study completion, an average of 14 weeks

    A self-report questionnaire that measures the strength of the client therapist alliance. The extent to which the participant agrees with each statement is rated on a scale of 1 (strongly disagree) to 6 (strongly agree)

  22. Moral Injury Events Scale (MIES)

    Time frame: Baseline

    A self-report survey that measures potentially morally injurious events. Each phrase is reacted on a Likert scale of 1 (Strongly Agree) to 6 (strongly disagree).

  23. Moral Injury Events Scale (MIES)

    Time frame: Through study completion, an average of 14 weeks

    A self-report survey that measures potentially morally injurious events. Each phrase is reacted on a Likert scale of 1 (Strongly Agree) to 6 (strongly disagree).

Study contacts

Contact information is provided by the study sponsor or research team.

Chandler Rhodes, Ph.D.

CONTACT

[email protected]

301-400-3638

Julie Sakla, M.A.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine
  • Uniformed Services University of the Health Sciences
  • University of Pennsylvania

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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