PTSDNCT05414708
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
A study testing Art Therapy in people with PTSD and Military Activity, run by Walter Reed National Military Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PTSD, Military Activity, Post-Traumatic Headache
- 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
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to Dec 2027
- Phase
- Interventional
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
- DEERS Eligible
- Active Duty or Veteran separated within the past 10 years
- Significant posttraumatic stress symptoms (score of >/=31 on the PCL-5)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julie Sakla, M.A. contact
United States2 sites, 2 recruiting
- Recruiting
National Intrepid Center of Excellence
Bethesda, Maryland, 20814
Julie Sakla, M.A., 240-390-6511, julie.sakla.ctr@health.mil
Chandler Rhodes, Ph.D., 301-400-3638, chandler.s.rhodes.civ@health.mil
- Recruiting
ISC at Fort Belvoir
Fort Belvoir, Virginia, 22060
Gioia Chilton, PhD, 571-231-1210, gioia.c.chilton.civ@health.mil
Gioia Chilton, PhD
About this study
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.
Read the 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.
- Conditions
- PTSD, Military Activity, Post-Traumatic Headache, Posttraumatic Stress Disorder, Posttraumatic Stress Disorder, Delayed Onset, Sleep Disturbance
- Being tested
- Art Therapy
- Keywords
- PTSD, Military, Art Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Post-Traumatic Headache, Parasomnias, Combat Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy Arm | Experimental | 8 weeks of individual art therapy 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 analysis of functional neuroimaging metrics
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.
Measured: Baseline
The Primary Outcome Measure is analysis of functional neuroimaging metrics
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.
Measured: Through study completion, an average of 14 weeks
Secondary outcomes (23)
Toronto Alexithymia Scale (TAS-20)
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.
Measured: Baseline
Toronto Alexithymia Scale (TAS-20)
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.
Measured: Through study completion, an average of 14 weeks
PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
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")
Measured: Baseline
PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
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")
Measured: Through study completion, an average of 14 weeks
PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
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")
Measured: Study completion, an average of six to eight months
Neurobehavioral Symptoms Inventory (NSI)
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
Measured: Baseline
Neurobehavioral Symptoms Inventory (NSI)
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
Measured: Through study completion, an average of 14 weeks
Neurobehavioral Symptoms Inventory (NSI)
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
Measured: Study completion, an average of six to eight months
General Self Efficacy Scale (GSES)
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).
Measured: Baseline
General Self Efficacy Scale (GSES)
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).
Measured: Through study completion, an average of 14 weeks
General Self Efficacy Scale (GSES)
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).
Measured: Study completion, an average of six to eight months
Generalized Anxiety Disorder-7 (GAD-7)
A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater
Measured: Baseline
Generalized Anxiety Disorder-7 (GAD-7)
A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater
Measured: Through study completion, an average of 14 weeks
Generalized Anxiety Disorder-7 (GAD-7)
A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater
Measured: Study completion, an average of six to eight months
Self-Regulation Questionnaire (SRQ)
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).
Measured: Baseline
Self-Regulation Questionnaire (SRQ)
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).
Measured: Through study completion, an average of 14 weeks
Self-Regulation Questionnaire (SRQ)
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).
Measured: Study completion, an average of six to eight months
Perceived Stress Scale (PSS)
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).
Measured: Baseline
Perceived Stress Scale (PSS)
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).
Measured: Through study completion, an average of 14 weeks
Perceived Stress Scale (PSS)
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).
Measured: Study completion, an average of six to eight months
Revised Helping Alliance Questionnaire (HAQ-II)
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)
Measured: Through study completion, an average of 14 weeks
Moral Injury Events Scale (MIES)
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).
Measured: Baseline
Moral Injury Events Scale (MIES)
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).
Measured: Through study completion, an average of 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Feb 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Pennsylvania, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Chandler Rhodes, PhD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414708
- Sponsor's protocol ID
- 2021-13476
- Status last verified
- Aug 2025
- First submitted
- 15 Dec 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No