Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Primary Purpose
PTSD, Military Activity, Post-Traumatic Headache
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Art Therapy
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Military, Art Therapy
Eligibility Criteria
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
Sites / Locations
- National Intrepid Center of ExcellenceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Art Therapy Arm
Arm Description
8 weeks of individual art therapy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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")
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")
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
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
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).
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).
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
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
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).
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).
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).
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).
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)
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).
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).
Full Information
NCT ID
NCT05414708
First Posted
December 15, 2021
Last Updated
June 14, 2022
Sponsor
Walter Reed National Military Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05414708
Brief Title
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Official Title
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Military Activity, Post-Traumatic Headache, Posttraumatic Stress Disorder, Posttraumatic Stress Disorder, Delayed Onset, Sleep Disturbance, Nightmare, Irritable Mood, Anger, Combat and Operational Stress Reaction, Combat Stress Disorders, Military Family, Military Operations
Keywords
PTSD, Military, Art Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Art Therapy Arm
Arm Type
Experimental
Arm Description
8 weeks of individual art therapy
Intervention Type
Behavioral
Intervention Name(s)
Art Therapy
Intervention Description
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 Measure Information:
Title
The Primary Outcome Measure is analysis of functional neuroimaging metrics
Description
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.
Time Frame
Week 1
Title
The Primary Outcome Measure is analysis of functional neuroimaging metrics
Description
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.
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Toronto Alexithymia Scale (TAS-20)
Description
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.
Time Frame
Week 1
Title
Toronto Alexithymia Scale (TAS-20)
Description
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.
Time Frame
Week 10
Title
PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
Description
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")
Time Frame
Week 1
Title
PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)
Description
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")
Time Frame
Week 10
Title
Neurobehavioral Symptoms Inventory (NSI)
Description
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
Time Frame
Week 1
Title
Neurobehavioral Symptoms Inventory (NSI)
Description
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
Time Frame
Week 10
Title
General Self Efficacy Scale (GSES)
Description
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).
Time Frame
Week 1
Title
General Self Efficacy Scale (GSES)
Description
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).
Time Frame
Week 10
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater
Time Frame
Week 1
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
A self-rated questionnaire that screens for generalized anxiety disorder. A recommended threshold for further evaluation is a score of 10 or greater
Time Frame
Week 10
Title
Self-Regulation Questionnaire (SRQ)
Description
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).
Time Frame
Week 1
Title
Self-Regulation Questionnaire (SRQ)
Description
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).
Time Frame
Week 10
Title
Perceived Stress Scale (PSS)
Description
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).
Time Frame
Week 1
Title
Perceived Stress Scale (PSS)
Description
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).
Time Frame
Week 10
Title
Revised Helping Alliance Questionnaire (HAQ-II)
Description
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)
Time Frame
Week 10
Title
Moral Injury Events Scale (MIES)
Description
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).
Time Frame
Week 1
Title
Moral Injury Events Scale (MIES)
Description
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).
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chandler Rhodes, Ph.D.
Phone
301-400-3638
Email
chandler.s.rhodes.civ@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Kayleigh M Scott, B.A.
Phone
301-400-1234
Email
kayleigh.m.scott2.ctr@mail.mil
Facility Information:
Facility Name
National Intrepid Center of Excellence
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayleigh M Scott, B.A.
Phone
301-400-1234
Email
kayleigh.m.scott2.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Chandler Rhodes, Ph.D.
Phone
301-400-3638
Email
chandler.s.rhodes.civ@mail.mil
First Name & Middle Initial & Last Name & Degree
Chandler Rhodes, Ph.D.
First Name & Middle Initial & Last Name & Degree
Anjan Chatterjee, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
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