- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414708
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Study Overview
Status
Conditions
- Anger
- PTSD
- Sleep Disturbance
- Posttraumatic Stress Disorder
- Combat Stress Disorders
- Emotional Regulation
- Nightmare
- Post-Traumatic Headache
- Military Activity
- Posttraumatic Stress Disorder, Delayed Onset
- Irritable Mood
- Combat and Operational Stress Reaction
- Military Family
- Military Operations
- Emotion Processing
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chandler Rhodes, Ph.D.
- Phone Number: 301-400-3638
- Email: chandler.s.rhodes.civ@health.mil
Study Contact Backup
- Name: Julie Sakla, M.A.
- Email: julie.sakla.ctr@health.mil
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20814
- Recruiting
- National Intrepid Center Of Excellence
-
Principal Investigator:
- Chandler Rhodes, Ph.D.
-
Principal Investigator:
- Anjan Chatterjee, Ph.D.
-
Contact:
- Chandler Rhodes, Ph.D.
- Phone Number: 301-400-3638
- Email: chandler.s.rhodes.civ@health.mil
-
Contact:
- Julie Sakla, M.A.
- Phone Number: 240-390-6511
- Email: julie.sakla.ctr@health.mil
-
-
Virginia
-
Fort Belvoir, Virginia, United States, 22060
- Recruiting
- ISC at Fort Belvoir
-
Contact:
- Gioia Chilton, PhD
- Phone Number: 571-231-1210
- Email: gioia.c.chilton.civ@health.mil
-
Principal Investigator:
- Gioia Chilton, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Art Therapy Arm
8 weeks of individual 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline
|
|
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. |
Through study completion, an average of 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Through study completion, an average of 14 weeks
|
|
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")
|
Baseline
|
|
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")
|
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
|
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")
|
Study completion, an average of six to eight months
|
|
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
|
Baseline
|
|
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
|
Through study completion, an average of 14 weeks
|
|
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
|
Study completion, an average of six to eight months
|
|
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).
|
Baseline
|
|
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).
|
Through study completion, an average of 14 weeks
|
|
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).
|
Study completion, an average of six to eight months
|
|
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
|
Baseline
|
|
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
|
Through study completion, an average of 14 weeks
|
|
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
|
Study completion, an average of six to eight months
|
|
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).
|
Baseline
|
|
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).
|
Through study completion, an average of 14 weeks
|
|
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).
|
Study completion, an average of six to eight months
|
|
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).
|
Baseline
|
|
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).
|
Through study completion, an average of 14 weeks
|
|
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).
|
Study completion, an average of six to eight months
|
|
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)
|
Through study completion, an average of 14 weeks
|
|
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).
|
Baseline
|
|
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).
|
Through study completion, an average of 14 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chandler Rhodes, PhD, WRNMMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Headache Disorders
- Sleep Wake Disorders
- Stress Disorders, Traumatic
- Headache Disorders, Secondary
- Behavior
- Social Behavior
- Self-Control
- Parasomnias
- Stress Disorders, Post-Traumatic
- Post-Traumatic Headache
- Combat Disorders
- Emotional Regulation
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Art Therapy
Other Study ID Numbers
- 2021-13476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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