AzTrials
AzTrials

TraumaTFATNCT05593302

The Effectiveness of Trauma Focused Art Therapy

A study testing Trauma-Focused Art Therapy (TFAT) in people with Trauma and Psychological, run by HAN University of Applied Sciences at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Trauma, Psychological, Art Therapy
What is being tested?
Trauma-Focused Art Therapy (TFAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteNetherlands
Study dates
10 Oct 2022to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Psychosis or acute crisis
  • intellectual disability (precluding the filling out of questionnaires).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • HAN University of Applied Sciences

    Nijmegen, Gelderland

Other trials in Netherlands

About this study

Official 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.

Read more

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.

Read the detailed description

INTRODUCTION:

About four in five people experience one or more distressing events in their lives. Ten percent of people subsequently develop post-traumatic stress disorder (PTSD). About 1.3 million people in the Netherlands will therefore have to deal with the consequences of PTSD at some point. PTSD is an anxiety disorder and causes serious complaints of re-experience, avoidance and increased irritability as a result of exposure to one or more traumatic events. The disorder causes significant distress or impairment in social, occupational, or other important areas of functioning,

According to the Anxiety Disorders Guideline and the guidelines of the National Institute for Health and Care Excellence (NICE), Cognitive Behavioral Therapy (CBT) and Eye Movement Desensitization and Reprocessing (EMDR) are the preferred treatments for PTSD. However, these interventions do not work for everyone - more than a third of patients do not benefit. This includes patients with very severe traumatization, with poor verbal memory and patients who are unable or patients who find it difficult to talk about the traumatic experiences.

Practice shows that art therapy (AT) offers an appropriate treatment for these patients. This is because the visual, tactile and experiential nature of AT fits well with the often wordless, visual and sensory nature of traumatic memories. Trauma-focused AT provides access to memories and emotions, can help to put these into words, and can be a possible preliminary stage (pretherapy) for other trauma-focused treatments (such as EMDR, CBT or NET).

Patient representatives underline the availability of trauma treatment based on AT because they believe that it offers an essential alternative to the usual verbal, often cognitive therapeutic approach. In addition, the Improvement Report Posttraumatic Stress Disorders from the Netherlands Healthcare Institute mentions, as one of the most important points for improvement, that more people with PTSD should receive specific trauma-oriented treatment.

AT is one of the arts therapies: The treatment tradition of arts therapies spans about a century and includes the disciplines: visual, drama, dance, music and psychomotor therapy. AT works through the use of numerous visual materials, methods and techniques to give meaning to past events and to gain more control over one's own life.

AT distinguishes itself from other treatments by its experiential approach and by the visible and tangible nature of the process and product of the treatment. Acting, doing and experiencing with visual material removes the feeling of powerlessness, increases the sense of control and the sense of self-worth. Working with visual material triggers emotions: it allows access to traumatic memories and emotions (AT makes it possible to express and shape, integrate and accommodate traumatic memories in a safe and staged way. The result of the visual work is visible, tangible and has a lasting character. This allows one to literally distance themselves from the emotion, integrate it cognitively and assign meaning. AT is more often applied in practice with good results according to patients and professionals, but has been insufficiently examined.

A Trauma-Focused Art Therapy protocol was previously developed. In a pilot study with patients with early childhood traumatization, this protocol was found to be acceptable, feasible and applicable. This protocol lends itself to transferring this method between art therapists, but has not yet been further investigated for effectiveness. In this project, this protocol is implemented, tested and evaluated by patients and professionals.

The Trauma-Focused Art Therapy protocol offers opportunities to improve accessibility, quality and effectiveness of trauma treatment, because patients who would otherwise not be treated or who would receive long-term treatments without results, now receive appropriate treatment. This concerns a short-term, individual trauma-focused AT consisting of 10 sessions (60 min.) in three phases (I: Stabilization and symptom reduction; II: Trauma processing; III: integration and attribution of meaning). After the first phase of getting acquainted, creating safety and determining a list of memories, phase 2 works on expressing and shaping positive and negative feelings, memories and thoughts. Phase 3 focuses on reordering, merging and finalizing the AT.

RESEARCH QUESTIONS:

Is the Trauma-Focused Art Therapy protocol an effective treatment of patients' trauma-related complaints

How do patients and art therapists experience this method?

OBJECTIVES:

The aim of this research is to gain insight into the effectiveness and functioning of trauma-focused AT. This contributes to evidence about the effectiveness of trauma treatment.

The aim is to better align trauma treatment with patients' needs to work on personal recovery in a different way. The protocol is tested in practice with the help of patients and professionals on: symptom reduction and psychological health.

HYPOTHESIS:

Art therapy offers an appropriate treatment for the group of multiple and long-term traumatized patients, who avoid and/or have difficulty talking about traumatic memories, because the visual and tangible character of art therapy seems to match the often wordless, visual and sensory nature of traumatic memories.Trauma-focused art therapy reduces PTSD symptoms (avoidance, arousal and re-experiencing) and depression (if there is comorbidity) and enhances self-confidence/self-esteem, mental resilience and positive health.

Being tested
Trauma-Focused Art Therapy (TFAT)
Keywords
Art Therapy, Trauma
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-Focused Art Therapy (TFAT)Behavioural

    Individual Trauma Focused Art Therapy (TFAT) consisting of 10 sessions. Each session lasts 60 minutes. Sessions are aimed at trauma recovery using visual art therapy. The sessions cover an introduction, making pieces of artwork, and reflection. Three phases can be distinguished:

    Phase 1: 'stabilization and symptom reduction', i.e. exploring traumatic and positive memories, imagining a lifecourse, and expressing a safe haven (4 sessions).

    Phase 2:'uttering and expressing memories', i.e. expressing chosen memories by making 5 pieces of artwork. Materials that can be used include clay, paint, graphite pencil or crayons and if needed with support of imagination using relevant photographs or objects (5 sessions).

    Phase 3: 'integration and meaning attribution', i.e. ordering and assembling of the 5 pieces of artwork. Patients are asked to appraise the memories in the here-and-now present (c.f. mindfulness-based cognitive therapy) (1 session).

Study groups in NCT05593302
Study groupRoleWhat they receive
Control Period - Intervention PeriodExperimentalMultiple baseline single case experimental design wherein all patients are first assigned to the control condition (or control period) are then assigned to the intervention condition (or intervention period) and finally to the follow-up period (control period). Patients are randomized for the time (t) at which they start with the intervention.
Receives: Behavioral: Trauma-Focused Art Therapy (TFAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 16-18 repeated measures of emotional self-expression and regulation, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))

Secondary outcomes (5)
  1. Rosenberg Self-Esteem Scale

    Rosenberg Self-Esteem Scale (RSES): Self-esteem assessed with ten 4-point scale items

    Measured: 16-18 repeated measures of self-esteem, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))

  2. 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

    Measured: 16-18 repeated measures of mental resiliency, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))

  3. 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

    Measured: 16-18 repeated measures of depression severity, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))

  4. 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

    Measured: 16-18 repeated measures of positive mental health, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))

  5. 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)

    Measured: Change from baseline PTSD symptoms at 15 weeks (after completion of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start10 Oct 2022
  3. Primary completion1 Jun 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multiple baseline single case experimental design (MBSCED) wherein all patients are first assigned to the control condition (or control period) and are then assigned to the intervention condition (or intervention period) and finally the follow-up period (control period). Patients are randomized for the time (t) at which they start with the intervention. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) recognizes the MBSCED as an experimental design (doi: 10.1016/j.jclinepi.2016.04.006).
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593302
Sponsor's protocol ID
TFAT SU1424 -101
Acronym
TFAT
Status last verified
Jun 2025
First submitted
12 Oct 2022
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will not make IPD directly available, but rather indirectly through a description of the meta-data and contact information of the principal investigator, to whom data requests can be sent.

Publications

  • Heijman J, Wouters H, Schouten KA, Haeyen S. Effectiveness of trauma-focused art therapy (TFAT) for psychological trauma: study protocol of a multiple-baseline single-case experimental design. BMJ Open. 2024 Jan 29;14(1):e081917. doi: 10.1136/bmjopen-2023-081917.

    PubMed 38286685

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-Focused Art Therapy (TFAT) in people with Trauma and Psychological, run by HAN University of Applied Sciences at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-expression and Emotion Regulation in Art Therapy Scale (time frame: 16-18 repeated measures of emotional self-expression and regulation, i.e. weekly over the course of 18 weeks (3-5 weeks control period + 10 weeks intervention + 3 weeks follow-up))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05593302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in