NCT05593302

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 10, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

October 12, 2022

Last Update Submit

August 27, 2025

Conditions

Keywords

Art TherapyTrauma

Outcome Measures

Primary Outcomes (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

    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)

  • Rosenberg Self-Esteem Scale

    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))

  • Resilience Scale

    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))

  • Beck Depression Inventory

    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))

  • Mental Health Continuum Short Form (MHC-SF)

    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))

  • Post-traumatic stress disorder Check List

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

Study Arms (1)

Control Period - Intervention Period

EXPERIMENTAL

Multiple 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.

Behavioral: Trauma-Focused Art Therapy (TFAT)

Interventions

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).

Control Period - Intervention Period

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Christine De Vries, Msc.

    HAN University of Applied Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Suzanne Haeyen

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 25, 2022

Study Start

October 10, 2022

Primary Completion

June 1, 2024

Study Completion

August 31, 2024

Last Updated

September 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the main paper until 10 years after this publication.
Access Criteria
The principal investigator will investigate whether requests are reasonable and feasible and adhere to ethical considerations.

Locations