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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414708
• Other study ID #: 2021-13476
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Walter Reed National Military Medical Center
• Contact: Chandler Rhodes, Ph.D.
• Phone: 301-400-3638
• Email: chandler.s.rhodes.civ[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Anger
• Combat and Operational Stress Reaction
• Combat Disorders
• Combat Stress Disorders
• Dyssomnias
• Fractures, Stress
• Headache
• Irritable Mood
• Military Activity
• Military Family
• Military Operations
• Nightmare
• Parasomnias
• Post-Traumatic Headache
• Posttraumatic Stress Disorder
• Posttraumatic Stress Disorder, Delayed Onset
• PTSD
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	National Intrepid Center of Excellence	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 1
Primary	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.	Week 10
Secondary	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.	Week 1
Secondary	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.	Week 10
Secondary	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")	Week 1
Secondary	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")	Week 10
Secondary	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	Week 1
Secondary	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	Week 10
Secondary	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).	Week 1
Secondary	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).	Week 10
Secondary	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	Week 1
Secondary	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	Week 10
Secondary	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).	Week 1
Secondary	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).	Week 10
Secondary	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).	Week 1
Secondary	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).	Week 10
Secondary	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)	Week 10
Secondary	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).	Week 1
Secondary	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).	Week 10