PTSD Clinical Trial
Official title:
Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
NCT number | NCT05414708 |
Other study ID # | 2021-13476 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | June 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | National Intrepid Center of Excellence | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Walter Reed National Military Medical Center |
United States,
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 |
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