NCT05414708

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2022Dec 2027

First Submitted

Initial submission to the registry

December 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 8, 2026

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

December 15, 2021

Last Update Submit

January 6, 2026

Conditions

Keywords

PTSDMilitaryArt Therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Through study completion, an average of 14 weeks

Secondary Outcomes (23)

  • Toronto Alexithymia Scale (TAS-20)

    Baseline

  • Toronto Alexithymia Scale (TAS-20)

    Through study completion, an average of 14 weeks

  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Baseline

  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Through study completion, an average of 14 weeks

  • PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)

    Study completion, an average of six to eight months

  • +18 more secondary outcomes

Study Arms (1)

Art Therapy Arm

EXPERIMENTAL

8 weeks of individual art therapy

Behavioral: Art Therapy

Interventions

Art TherapyBEHAVIORAL

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.

Art Therapy Arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DEERS Eligible
  • Active Duty or Veteran separated within the past 10 years
  • Significant posttraumatic stress symptoms (score of \>/=31 on the PCL-5)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Intrepid Center of Excellence

Bethesda, Maryland, 20814, United States

RECRUITING

ISC at Fort Belvoir

Fort Belvoir, Virginia, 22060, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPost-Traumatic HeadacheParasomniasCombat DisordersEmotional Regulation

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSleep Wake DisordersSelf-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chandler Rhodes, PhD

    WRNMMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Sakla, M.A.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

June 10, 2022

Study Start

February 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 8, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations