Trauma Clinical Trial
— TFATOfficial title:
The Effectiveness of Trauma Focused Art Therapy: a Multiple Baseline Single Case Experimental Design
More than 30% of patients with trauma-related complaints do not benefit from prescribed treatments. This concerns patients who have either a poor verbal memory or who are unable or do not wish to talk about their experiences. In clinical practice, trauma-oriented art therapy appears to be an appropriate treatment. The visual, tangible, experiential character of art therapy is in line with the often wordless, visual and sensory nature of trauma. Art therapy aims to contribute to achieving personal goals through the use of visual materials and techniques. This approach has been insufficiently examined. Treatment of refugees with Trauma-Focused Art Therapy has previously been shown to be feasible in clinical practice and acceptable to patients. Using a Mixed Method design, the researchers aim to measure the effect of this protocol in specialized mental health care and the experience of patients with regard to their personal recovery.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 31, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Having trauma-related symptoms ((i.e. nightmares, flashbacks, persistent fatigue or depression, anxiety in regards to specific triggers, sleep disorders) - Being eligible for art therapy on discretion of multidisciplinary treatment panel (consisting of, for example. a psychiatrist, psychologists, sociotherapists, and art therapists) - Being motivated to work on traumatic memories Exclusion Criteria: - Psychosis or acute crisis - intellectual disability (precluding the filling out of questionnaires). |
Country | Name | City | State |
---|---|---|---|
Netherlands | HAN University of Applied Sciences | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
HAN University of Applied Sciences |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-expression and Emotion Regulation in Art Therapy Scale | Self-expression and Emotion Regulation in Art Therapy Scale (SERATS): Assessment of emotional self-expression and regulation during therapy with 9 5-point scale items | 15-18 repeated measures of emotional self-expression and regulation, i.e. weekly over the course of 18 weeks (2-5 weeks control period + 10 weeks intervention + 3 weeks follow-up)) | |
Secondary | Rosenberg Self-Esteem Scale | Rosenberg Self-Esteem Scale (RSES): Self-esteem assessed with ten 4-point scale items | 15-18 repeated measures of self-esteem, i.e. weekly over the course of 18 weeks (2-5 weeks control period + 10 weeks intervention + 3 weeks follow-up)) | |
Secondary | Resilience Scale | Resilience Scale (RS): Mental resiliency i.e. how patients cope with challenges, drawbacks, and distressing circumstances assessed with 25 4-point scale items | 15-18 repeated measures of mental resiliency, i.e. weekly over the course of 18 weeks (2-5 weeks control period + 10 weeks intervention + 3 weeks follow-up)) | |
Secondary | Beck Depression Inventory | Beck Depression Inventory (BDI): Severity of depression scored in the domains of affective, cognitive and somatic symptoms assessed with 21 4-point scale items | 15-18 repeated measures of depression severity, i.e. weekly over the course of 18 weeks (2-5 weeks control period + 10 weeks intervention + 3 weeks follow-up)) | |
Secondary | Mental Health Continuum Short Form (MHC-SF) | Mental Health Continuum Short Form (MHC-SF): positive mental health in the domains of emotional, psychological, and social wellbeing using 14 items | 15-18 repeated measures of positive mental health, i.e. weekly over the course of 18 weeks (2-5 weeks control period + 10 weeks intervention + 3 weeks follow-up)) | |
Secondary | Post-traumatic stress disorder Check List | Post-traumatic stress disorder Check List (PCL): screener of symptoms of PTSD using 20 items based on the Diagnostic and Statistical Manual 5th edition (DSM-5) | Change from baseline PTSD symptoms at 15 weeks (after completion of intervention) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |