Personality DisordersNDPDNCT06219122
The Effectiveness of a Creative Arts en Psychomotor Therapy Intervention for People With Personality Disorders. From Negative Thinking to Positive Acting.
A study testing Creative arts and psychomotor therapies intervention for people with personality disorders in people with Personality Disorders, run by Suzanne Haeyen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Personality Disorders
- What is being tested?
- Creative arts and psychomotor therapies intervention for people with personality disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jan 2024to 1 Feb 2025
- 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
- being diagnosed with one or more PD according to the DSM-V criteria
- being motivated for CAPTs
- able to participate in group therapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Creative Arts en Psychomotor Therapy Intervention for People With Personality Disorders to Enhance Psychological Adaptation and Wellbeing, a Multiple Baseline Single Case Experimental Design.
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.
Read more
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.
Read the detailed description
Personality disorders are common psychiatric disorders. 5%-10% of all Dutch people have a personality disorder. The best-known personality disorders are borderline, narcissistic and avoidant personality disorders. Personality disorders often arise in adolescence. Deep-seated limitations in behavior, thoughts, feelings, connection and intimacy lead to long-term dysregulation in dealing with oneself and others. This causes problems in several areas of life that patients can no longer solve themselves, including difficulties in intimate relationships and incapacity for work. Specialist treatment can turn the tide.
Creative arts and psychomotor therapies (CAPTS) are often a permanent part of the treatment for personality disorders, in addition to psychotherapy and psychotropic drugs. The treatment tradition of the CAPTS spans approximately a century and includes the disciplines: art, drama, dance, music and psychomotor therapy. For professional therapists, the patients' request for help is the starting point. The treatments for the various personality disorders therefore often overlap. The CAPTS focus on experiencing and doing. Feelings, thoughts and behavioral patterns emerge through making art, play, music or physical sensation. Awareness and (self) reflection are stimulated and new roles and skills are practiced in a safe manner.
With CAPTS, patients with a personality disorder can develop more appropriate ways of relating to themselves and others. To date, little practice-oriented research has been conducted into the treatment of personality disorders with occupational therapy. However, the Dutch Healthcare Institute insists on substantiation of the effectiveness of the CAPTS to justify its reimbursement. There is also an increasing demand for this from the professional organizations of professional therapists and patient organizations.
Existing treatments for personality disorders are aimed at reducing complaints. However, mental health also consists of the presence of well-being. Well-being is about whether someone feels good psychologically, emotionally and socially. Even if patients have physical and psychological complaints. Patients with a personality disorder often have low well-being. Promoting well-being is an important step towards their recovery, which is an important treatment goal according to the treatment guideline. Working on better psychological adaptation is how this can be achieved, one will get more adaptive to their own emotional needs within the context of daily life. Wellbeing will be improved accordingly.
CAPTS professionals indicate that no specific treatment module with CAPTS interventions has yet been developed to promote the psychological adaptation and well-being of patients with a personality disorder. From a professional point of view, they feel the need for this, because that is precisely where their strength lies. Patient organizations confirm the importance of this from the patient perspective.
When developing and evaluating CAPTS interventions, it is therefore important to promote psychological adaptation and well-being of patients with a personality disorder, in addition to reducing complaints.
In summary, personality disorders are common and serious psychiatric disorders that impair psychological and social functioning. CAPTS treatment is promising for promoting psychological adaptation and well-being of patients with personality disorders. However, treatment specifically aimed at this is not yet available in practice. Practical research into the development and evaluation of CAPTS interventions meets an important and immediate need in the professional field and is in line with the treatment guidelines for personality disorders and various national research agendas. From a social perspective, the proper treatment of people with serious psychological suffering is an important issue.
Research Question:
How can the various CAPTS disciplines promote psychological adaptivity in patients with a personality disorder and what is the effect of this approach on complaint reduction and well-being?
Aim of this research:
Designing and testing a practical and broadly applicable module with CAPTS interventions and a practical manual that promote psychological adaptation and well-being of people with personality disorders.
- Conditions
- Personality Disorders
- Being tested
- Creative arts and psychomotor therapies intervention for people with personality disorders
- Keywords
- Personality Disorders, Mental wellbeing, Creative arts and Psychomotor therapies
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative arts and psychomotor therapies intervention for people with personality disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Creative arts and psychomotor therapies intervention for people with personality disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic sense of ability to adapt scale (GSAAS)
Assessment of the ability to adapt with 10 5-point scale items.
Measured: 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)
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: 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)
Assessment of adaptive schemamodes the Healthy adult and Happy Child, with 20 6-point scale items.
Measured: 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)
Assessment of maladaptive schemamodes, with 98 6-point scale items.
Measured: 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).
Assessment of Mental wellbeing, with 14 6-point scale items
Measured: 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).
Assessment of sympoms of psychopathology, with 53 5-points scale items.
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start31 Jan 2024
- Primary completion30 Nov 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Personality DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzanne Haeyen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Sponsor-investigator, Suzanne Haeyen, HAN University of Applied Sciences
- Investigators
- Christine de Vries, MSc, Study director, HAN University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219122
- Sponsor's protocol ID
- NDPD - SU1606
- Acronym
- NDPD
- Status last verified
- Jun 2025
- First submitted
- 22 Dec 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37063565Bohlmeijer 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.
PubMed 34744925Franken, 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.
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.
PubMed 39740945
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Creative Arts en Psychomotor Therapy Intervention for People With Personality Disorders to Enhance Psychological Adaptation and Wellbeing, a Multiple Baseline Single Case Experimental Design.
- ClinicalTrials.gov ID
- NCT06219122
- Acronym / sponsor ID
- NDPD / NDPD - SU1606
- Conditions
- Personality Disorders
- Keywords
- Personality Disorders, Mental wellbeing, Creative arts and Psychomotor therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Suzanne HaeyenUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Personality disorders are common psychiatric disorders. 5%-10% of all Dutch people have a personality disorder. The best-known personality disorders are borderline, narcissistic and avoidant personality disorders. Personality disorders often arise in adolescence. Deep-seated limitations in behavior, thoughts, feelings, connection and intimacy lead to long-term dysregulation in dealing with oneself and others. This causes problems in several areas of life that patients can no longer solve themselves, including difficulties in intimate relationships and incapacity for work. Specialist treatment can turn the tide.
Creative arts and psychomotor therapies (CAPTS) are often a permanent part of the treatment for personality disorders, in addition to psychotherapy and psychotropic drugs. The treatment tradition of the CAPTS spans approximately a century and includes the disciplines: art, drama, dance, music and psychomotor therapy. For professional therapists, the patients' request for help is the starting point. The treatments for the various personality disorders therefore often overlap. The CAPTS focus on experiencing and doing. Feelings, thoughts and behavioral patterns emerge through making art, play, music or physical sensation. Awareness and (self) reflection are stimulated and new roles and skills are practiced in a safe manner.
With CAPTS, patients with a personality disorder can develop more appropriate ways of relating to themselves and others. To date, little practice-oriented research has been conducted into the treatment of personality disorders with occupational therapy. However, the Dutch Healthcare Institute insists on substantiation of the effectiveness of the CAPTS to justify its reimbursement. There is also an increasing demand for this from the professional organizations of professional therapists and patient organizations.
Existing treatments for personality disorders are aimed at reducing complaints. However, mental health also consists of the presence of well-being. Well-being is about whether someone feels good psychologically, emotionally and socially. Even if patients have physical and psychological complaints. Patients with a personality disorder often have low well-being. Promoting well-being is an important step towards their recovery, which is an important treatment goal according to the treatment guideline. Working on better psychological adaptation is how this can be achieved, one will get more adaptive to their own emotional needs within the context of daily life. Wellbeing will be improved accordingly.
CAPTS professionals indicate that no specific treatment module with CAPTS interventions has yet been developed to promote the psychological adaptation and well-being of patients with a personality disorder. From a professional point of view, they feel the need for this, because that is precisely where their strength lies. Patient organizations confirm the importance of this from the patient perspective.
When developing and evaluating CAPTS interventions, it is therefore important to promote psychological adaptation and well-being of patients with a personality disorder, in addition to reducing complaints.
In summary, personality disorders are common and serious psychiatric disorders that impair psychological and social functioning. CAPTS treatment is promising for promoting psychological adaptation and well-being of patients with personality disorders. However, treatment specifically aimed at this is not yet available in practice. Practical research into the development and evaluation of CAPTS interventions meets an important and immediate need in the professional field and is in line with the treatment guidelines for personality disorders and various national research agendas. From a social perspective, the proper treatment of people with serious psychological suffering is an important issue.
Research Question:
How can the various CAPTS disciplines promote psychological adaptivity in patients with a personality disorder and what is the effect of this approach on complaint reduction and well-being?
Aim of this research:
Designing and testing a practical and broadly applicable module with CAPTS interventions and a practical manual that promote psychological adaptation and well-being of people with personality disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| A CAPTS intervention for people with personality disorders. | Experimental | Behavioral: Creative arts and psychomotor therapies intervention for people with personality disordersExperimental: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being diagnosed with one or more PD according to the DSM-V criteria
- being motivated for CAPTs
- able to participate in group therapy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creative arts and psychomotor therapies intervention for people with personality disordersa 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. | Behavioural | A CAPTS intervention for people with personality disorders. |
Primary outcome
Generic sense of ability to adapt scale (GSAAS)
Time frame: 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)
Assessment of the ability to adapt with 10 5-point scale items.
5 secondary outcomes
Self-expression and Emotion Regulation in Art Therapy Scale (SERATS)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 37063565Franken 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.
- Background: PubMed 34744925Bohlmeijer 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.
- BackgroundFranken, 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.
- Derived from this study: PubMed 39740945Wiersma 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine de Vries, MSc study director
HAN University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creative arts and psychomotor therapies intervention for people with personality disorders in people with Personality Disorders, run by Suzanne Haeyen 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 5 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 1 Jul 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?
Generic sense of ability to adapt scale (GSAAS) (time frame: 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)). 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 NCT06219122, which also lists 4 linked publications.
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 1 Jul 2025.