NCT06219122

Brief Summary

Mental health consists of the absence of mental disorders and the presence of mental well-being. However; mental health care currently focuses mainly on mental disorders and less on promoting mental well-being. And yet people with personality problems often score very low on well-being. In order to work on sustainable mental health, attention is needed for both mental complaints and well-being and this is achieved through promoting psychological adaptation. Psychological adaptation is the process in which a person deals in a healthy way with their own needs, emotions and inner signals (such as stress) as well as the smaller or larger challenges in life. For people with personality problems psychological adaptation is also low, they mainly react in rigid patterns. Creative arts and psychomotor therapies (CAPTS) are a non-verbal form of therapy in which various creative methods, such as theater, sports, dance, music and sports methods, are used to make contact with emotions and to practice healthier ways of dealing with them. This is very suitable for working on promoting psychological adaptivity, within a safe and playful context. It's about doing and experiencing, and discovering what works for you personally, more than talking and understanding. That this is effective is endorsed by professionals and clients in mental health care, but scientific evidence is still scarce. That is why a specially developed, CAPTS module for people with personality problems will be investigated in a mixed methods design. We focus on both effectiveness and working mechanisms in a Multiple Baseline Single Case Experimental Design and a qualitative approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

December 22, 2023

Last Update Submit

June 27, 2025

Conditions

Keywords

Personality DisordersMental wellbeingCreative arts and Psychomotor therapies

Outcome Measures

Primary Outcomes (1)

  • Generic sense of ability to adapt scale (GSAAS)

    Assessment of the ability to adapt with 10 5-point scale items.

    Up to 23 repeated measures, i.e. weekly over the course of 23 weeks (5-8 weeks control period + 10 weeks intervention + 5 weeks follow-up)

Secondary Outcomes (5)

  • Self-expression and Emotion Regulation in Art Therapy Scale (SERATS)

    Up to 23 repeated measures, i.e. weekly over the course of 23 weeks (5-8 weeks control period + 10 weeks intervention + 5 weeks follow-up)

  • Schema Modes Questionnaire, Healthy adult and Happy Child Subscale. (SMI)

    Up to 23 repeated measures, i.e. weekly over the course of 23 weeks (5-8 weeks control period + 10 weeks intervention + 5 weeks follow-up)

  • Schema Modes Questionnaire, maladaptive schemamodes. (SMI)

    2 repeated measures of the SMI the maladaptive modes, at the start of the control period and at the end of the follow up period, max. 23 weeks apart]

  • Mental Health Continuum- short form (MHC-sf).

    2 repeated measures of the MHC-sf for Mental wellbeing, at the start of the control period and at the end of the follow up period, max. 23 weeks apart]

  • Brief Symptom Inventory (BSI).

    2 repeated measures of the BSI for, at the start of the control period and at the end of the follow up period, max. 23 weeks apart]

Other Outcomes (1)

  • Interviews with the participants and therapists

    Once 3 weeks after the intervention

Study Arms (1)

A CAPTS intervention for people with personality disorders.

EXPERIMENTAL

Experimental: Control Period - Intervention Period 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: Creative arts and psychomotor therapies intervention for people with personality disorders

Interventions

a Group (max of 9 participants) Creative arts and psychomotor therapies (CAPTS) intervention for people with personality disorders. Consisting of 10 sessions, where two CAPTS disciplines and therapists are represented each session. Each session lasts 90 minutes. Sessions are aimed at psychological adativity thru=ough the CAPTS. The sessions cover warming up in one of the CAPTS, short psycho education and a longer assigment focusing on the session goal. The first half of the interventions focusses mainly on listening to body signals, emotions and emotional needs and dealing in a healthy way with these. The second half will be more complex when dealing with challenges and adapting tot he context in a healthy way are goals of the sessions.

A CAPTS intervention for people with personality disorders.

Eligibility Criteria

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

You may qualify if:

  • being diagnosed with one or more PD according to the DSM-V criteria
  • being motivated for CAPTs
  • able to participate in group therapy

You may not qualify if:

  • acute psychosis or crisis
  • prominent PTSD symptoms which require specialised trauma treatment
  • a suspected eating disorder defined as a BMI lower than 18,
  • an IQ below 85,
  • insufficient command of the Dutch language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, Gelderland, Netherlands

Location

Related Publications (4)

  • Franken K, Schuffelen P, Ten Klooster P, van Doesum K, Westerhof G, Bohlmeijer E. Introduction of the generic sense of ability to adapt scale and validation in a sample of outpatient adults with mental health problems. Front Psychol. 2023 Mar 29;14:985408. doi: 10.3389/fpsyg.2023.985408. eCollection 2023.

    PMID: 37063565BACKGROUND
  • Bohlmeijer E, Westerhof G. The Model for Sustainable Mental Health: Future Directions for Integrating Positive Psychology Into Mental Health Care. Front Psychol. 2021 Oct 21;12:747999. doi: 10.3389/fpsyg.2021.747999. eCollection 2021.

    PMID: 34744925BACKGROUND
  • Franken, C.P.M., Vos, J.A. de, Westerhof, G.J., & Bohlmeijer, E. (2019). De Mental Health Continuum Short Form (MHC-SF), een handleiding voor behandelaren in de geestelijke gezondheidszorg voor het interpreteren en bespreken van scores met patiënten. Enschede; Universiteit Twente.

    BACKGROUND
  • Wiersma IC, Wouters H, Timmerman K, Heijman J, Westerhof GJ, Radstaak M, Haeyen S. Promoting psychological adaptability and well-being of patients with personality disorders with creative arts and psychomotor therapies: protocol of an intervention mapping study. BMJ Open. 2024 Dec 31;14(12):e090275. doi: 10.1136/bmjopen-2024-090275.

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

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 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. CONSORT recognizes this design as an N=1 Trial, please refer to https://www.consort-statement.org/extensions/overview/n-of-1
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr. Suzanne Haeyen, professor of arts and psychomotor therapies

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 23, 2024

Study Start

January 31, 2024

Primary Completion

November 30, 2024

Study Completion

February 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

We will make IPD available, but personal data will not be shared at all. Using a doi for the processed data giving a description of the meta-data and then data can be requested at 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