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Abstract
Introduction Personality disorders (PDs) cause much suffering. In treating patients with PDs, it is important not only to focus on reducing symptoms, but also on promoting psychological adaptability and well-being. The experiential nature of Creative Arts and Psychomotor Therapies (CAPTs) contributes to working on psychological adaptability and improving well-being, although more evidence is needed. This protocol paper describes a study to develop and evaluate a CAPTs-intervention aimed at promoting psychological adaptability and well-being in people with PDs.
Methods and analysis The CAPTs-intervention will be developed using the Intervention Mapping method. A mixed method design will be used for the evaluation of this intervention, using a multiple baseline single case experimental design (MBSCED) with at least 17 participants with a PD included. Quantitative measures that will be completed weekly are the Generic Sense of Ability to Adapt Scale, the Self-Expression and Emotion Regulation in Art Therapy Scale and the Schema Mode Inventory (SMI, healthy adult and happy child). The Mental Health Continuum Short Form, the Brief Symptom Inventory and the SMI (complete) will only be completed at week 1 and 10 of the intervention. Qualitative instruments are an online survey for Experts by Experience, focus groups for CAPTs-therapists, psychologists, managers and referrers, and semi-structured interviews with patients. Quantitative outcomes will be analysed with linear mixed models. Qualitative analysis will be performed using thematic analysis.
Ethics and dissemination This study has been approved by the Research Ethics Committee of the HAN University of Applied Sciences (ref: ECO 471.07/23). All participants will sign an Informed Consent and data will be treated confidentially. Study findings will be published Open Access in peer-reviewed journals.
Trial registration number This study has been registered at https://www.ClinicalTrials.gov (trial registration number NCT06219122).
- Personality disorders
- Psychiatry
- Qualitative Research
- Patient Reported Outcome Measures
- Mental Health
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This study focuses on positive mental health outcomes.
In this study, a Creative Arts and Psychomotor Therapies-intervention is developed with the intervention mapping method.
This study includes quantitative data as well as patients’ and therapists’ experiences and preferences.
Patients with cluster A personality disorders are difficult to reach, hence, difficult to enrol.
The repeatedly measured outcomes require patients to complete a larger number of questionnaires. during a prolonged period, which is burdening and is likely to result in missing data.
Introduction
Personality disorders (PDs) are severe psychiatric disorders with a persistent course. In the Netherlands, the estimated prevalence of PDs ranges between 5% and 10%.1 PDs are characterised by persistent, rigid and maladaptive patterns of inner experiences and behaviours, which are often the result of genetic predisposition and coping with Adverse Childhood Experiences.2 Maladaptive patterns in behaviour, feelings and thoughts lead to long-term disruption of intrapersonal and interpersonal relationships.3 4 This results in difficulties in strengthening their own well-being, sometimes even resisting positive experiences.5 Furthermore, having a PD is often accompanied by comorbidity of other psychopathologies such as depression, anxiety and addiction and causes much personal suffering.1 2 5 Specialised treatment for PDs is warranted and should not only focus on decreasing PD symptoms such as maladaptive patterns, but also on improving well-being and psychological adaptability. This has often been referred to as the two-continua model (e.g., focusing on both mental illness, and mental health).6
In treating patients with PD, there are several ways to work on psychological adaptability. A commonly used psychotherapy is Schema-Focused Therapy (SFT), which has been developed by Jeffrey Young7 for patients with PD. In SFT, Young distinguishes between schemas and modes. Feelings and thoughts are guided by schemas,7–9 whereas modes are the affective states brought about by schemas. Patients with PDs have dysfunctional schemas and dysfunctional modes.10 SFT aims to work on decreasing these dysfunctional schemas and modes and developing functional and positive ones. In SFT terminology, Happy Child and Healthy Adult functioning are specifically described as functional modes and these focus on fulfilling emotional needs in a healthy and adaptive way.9–11
Positive Psychology also focusses on psychological adaptability by targeting mental health, well-being, strength, reinforcement of positive affect and flow.12–14 In the model of sustainable mental health15 positive psychology and mental well-being are integrated into mental healthcare. Huber et al16 states that health is a dynamic ability to adapt and control oneself as much as possible considering the social, mental and physical challenges of life. Therefore, it is important not only to focus on symptom reduction in treatment, but also on strengthening well-being by focusing interventions on positive behaviours, emotions and thoughts.15 17–20 Recent studies show that these types of interventions contribute to decrease in psychological symptoms and increase in well-being in clinical populations.21
While SFT and other forms of psychotherapy are more cognitive in nature and focus on thoughts and perceptions, Creative Arts and Psychomotor Therapies (CAPTs) are experiential and focus on sensations, emotions and behaviours. CAPTs are often offered to reduce clinical symptoms and improve the psychological well-being of PDs and other psychological disorders.22–24 These therapies include visual art, drama, music, dance and psychomotor therapy. Thoughts, feelings and behavioural patterns can be expressed or elicited through, for example, drawing/painting, creating, bodily awareness, theatre/role-playing or music, in specific working methods of the CAPTs. Awareness and (self-)reflection are stimulated and new skills and roles are practiced in an accessible and secure setting.25–28 The experiential, creative, playful and ‘as if’ nature of the CAPTs contributes to working on the psychological challenges of PDs and improving psychological well-being.22 CAPTs, like psychotherapy, can be Schema-Focused. CAPTs working methods elicit patients’ own dysfunctional schemes and modes and provide insight therein.9 29 Subsequently, patients with PDs can learn to replace these dysfunctional schemes and modes and practice functional and adaptive ones such as the Healthy Adult, which promotes the Happy Child mode by fulfilling their basic emotional needs in connection with themselves and others.9 29 The CAPTs working methods convey various manners to stimulate positive schemas and adaptive modes, such as reappraising sensory stimuli, improvising this by trying new behaviour, and resolving conflict between basic needs and dysfunctional modes.29 Through the creative, playful and experiential nature of CAPTs, patients can develop more adequate ways of coping with and adapting to daily life situations.9 Hence, combining CAPTs with SFT could be beneficial in the treatment of PDs.
To date, few CAPTs-interventions exist aimed at improving psychological adaptability, and there has been little practice-based research on the treatment of PDs with CAPTs. There is a growing demand for evidence-based CAPTs-interventions, with these interventions often perceived as positive in practice by patients and therapists. According to professionals, patients and research results, CAPTs show promise for promoting psychological adaptability and well-being of patients with PDs. In March 2021, we conducted a survey in which CAPTs-therapists expressed a preference for an intervention that aligns with SFT (unpublished data). Therefore, we will develop a CAPTs-intervention based on SFT and positive psychology interventions. Haeyen30 published a book with this focus containing many practice-based working methods. These methods form the basis for the development of a CAPTs-intervention. The goal of this intervention will be to reinforce psychological adaptability and well-being by strengthening helpful schemas and modes.
Research aims
To develop a CAPTs-intervention based on SFT and positive psychology that is aimed at promoting psychological adaptability and well-being.
To evaluate the effectiveness of the CAPTs-intervention in promoting psychological adaptability and well-being in patients with PDs.
Methods and analysis
Design
This Intervention Mapping (IM) study will combine quantitative and qualitative methods. IM is a systematic method for developing, implementing and evaluating healthcare interventions.31 Each step includes certain tasks integrating theory and evidence and results in a product that is the guide for the next step. These steps are used to arrive at an intervention that promotes health.31
Steps 1 and 2 (Needs assessment and Change Objectives) start with a literature review of working mechanisms in CAPTs in PDs. Subsequently, six focus groups will be held: five consisting of the different disciplines of CAPTs-therapists (visual art, music, dance, drama and psychomotor) and one focus group of psychologists, psychotherapists and managers, all of them specialised in the treatment of patients with PDs. Lastly, a survey will be held among Experts by Experience. Based on the input of the data collection in Step 1, we will produce a Matrix of Change Objectives in step 2.
In Step 3 and Step 4 (Theoretical methods and practical strategies and Intervention development), two art therapists will make an initial selection of practical strategies. The chosen methods and assignments will then be viewed by other CAPTs-therapists from all disciplines, to increase inter-rater reliability. This is an integrative process in which the expertise of different CAPTs-therapists is combined. This will result in a CAPTs-intervention and practical guidance for professionals, so that they can use the intervention in the treatment of patients with PDs.
Once the intervention has been developed, in Step 5 (Implementation), we will conduct interviews with programme managers, CAPTs-therapists and psychiatrists to test the conditions for implementation. In addition, we will test the feasibility of the CAPTs-intervention with students in the university’s CAPTs programme and with patients in a treatment setting. Students and patients will participate in five different therapy sessions of the CAPTs-intervention, to test whether the sessions are feasible in time and if the variety of working methods works.
In Step 6 (Evaluation), the test-phase of the study, comprises a mixed method approach consisting of a multiple-baseline single-case experimental design (MBSCED) and qualitative interviews that together allow us to evaluate the intervention’s effectiveness. In an MBSCED, participants are monitored over time and repeated measurements are conducted, in our case weekly. Participants will be randomised for the time at which they start the treatment, resulting in baselines varying from 5 to 7 weeks. All patients will then start the intervention for 10 weeks, with a follow-up period of 5 weeks. By randomising the baseline period, each participant functions as his/her own control, enabling us to isolate treatment effects.32 The MBSCED accounts adequately for threats to internal validity (e.g., maturation, history and regression to the mean—instead of the CAPTs-intervention—as rival explanations for improvement rather than CAPTs treatment). Based on the power analysis for an MBSCED, assuming a medium effect size (Cohen’s d=0.5), an autocorrelation of 0.2, at least 20 measurements, and an α of 5%, an inclusion of 10 participants yields >80% power.33 Measurements in the intervention period will be compared with measurements at baseline and follow-up. The intervention will conclude with semi-structured interviews exploring the perceived effects and experiences of patients and therapists.
Study setting
The study will last for 24 months, with preparation from February 2023 to publication of findings in February 2025. The test-phase will be conducted in three mental health facilities, specialised in the treatment of patients with PDs. We verified the potential number of eligible participants and concluded that including at least 17 patients is feasible. We expect to start at least three therapy groups involving six different CAPTs-therapists, two per therapy group. The CAPTs-intervention will be given in addition to the usual treatment. This may include outpatient treatment, part-time treatment or inpatient treatment for PDs.
Eligibility criteria
Students in Step 5 of IM will be recruited through the university’s CAPTs programme. Patients in Steps 5 and 6 of IM will be enrolled by art therapists and clinicians. The eligibility criteria will be as follows: (1) being diagnosed with one or more PD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, (2) age between 18 and 65 years, (3) being motivated for CAPTs and (4) being able to participate in group therapy. The patient’s multidisciplinary treatment panel will, in consultation with the patient, determine whether the criteria are met. Exclusion criteria include: (1) acute psychosis or crisis, (2) prominent post-traumatic stress disorder (PTSD) symptoms which require specialised trauma treatment, (3) a suspected eating disorder defined as a body mass index lower than 18, (4) an IQ below 85 and (5) insufficient command of the Dutch language.
Procedure
All recruited participants will sign an Informed Consent which has been ethically approved by the ethics committee of the HAN University of Applied Sciences. The Informed Consent explains the data collection, management procedures and other ethical aspects, and emphasises that participation is voluntary (for an example, see Patient Consent Form). All participants will be informed verbally about the study by researchers before enrolment. Participants can stop participating in the study at any time.
In Steps 1 and 2 of IM, the Experts by Experience who participate in the online survey, will be invited through an online platform for mental healthcare patients and their families (MIND). Furthermore, participating CAPTs-therapists, psychologists and managers in the six focus groups, will be recruited through the Federation of Dutch CAPTs-therapist, through the participating institutions and an earlier survey. Information will be collected about the needs and preferences of professionals who work with people with PD. In these focus groups, the treatment of people with PD, (working mechanisms of) the CAPTs, the potential form and nature of the intervention and psychological adaptability will be discussed.
The CAPTs-therapists participating in Steps 3 and 4 of IM, are being recruited among participants in focus groups and through our own network. The programme managers, CAPTs-therapists and psychiatrists who will be participating in interviews to test the conditions for implementation in Step 5 of IM, will be recruited through the participating institutions. Participating students in Step 5 of IM, will be informed via email and an information letter about the intervention and the meetings in which they will experience the intervention.
Participating CAPTs-therapists who will implement the intervention in Step 6 of IM, will be recruited from the various participating mental health facilities. They are required to be certified in CAPTs, work in mental healthcare clinics and have experience with SFT and treating patients with PD. They will be instructed by one of the researchers about the to-be-developed CAPTs-intervention and the data collection methods. Participating CAPTs-therapists will be provided with practical guidelines about the intervention. To discuss any insights or problems that arise, they will be asked to join online supervision sessions. On completion of the intervention, the CAPTs-therapists will be asked to participate in a focus group about the use and effects of the intervention, their experiences and about the working mechanisms of the CAPTs-intervention. The psychologists referred to the patients will also participate in a focus group together, to ask if and why people should be referred to the CAPTs and discuss their experiences with the intervention.
Patients who participate in Steps 5 and 6 of IM will be recruited at attending mental health facilities, by their treating clinicians when the CAPTs-intervention is in line with their treatment goals. The intervention is complementary to their treatment as usual. Patients will be informed through their treating clinicians about the study and through an information letter. At the start of the intervention, patients will receive a patient number and a computer-generated, randomised baseline period lasting from 5 to 7 weeks, followed by the CAPTs-intervention (10 weeks) and follow-up (5 weeks). One researcher will create the numbers, another researcher will do the allocation of the computer-generated baseline periods. To prevent the questionnaire burden, not every outcome will be assessed each week. Since the Generic Sense of Ability to Adapt Scale (GSAAS), Self-Expression and Emotion Regulation in Art Therapy Scale (SERATS), and Schema Mode Inventory (SMI) healthy adult and happy child are the direct and relevant outcomes for adaptability, these 38 items in total will be assessed every week. The Mental Health Continuum – short form (MHC-SF), Brief Symptom Inventory (BSI) and complete version of the SMI, a total of 165 items will only be completed at the start of the intervention and after the final therapy session. Since well-being (as measured with the MHC-SF) is expected to increase only after a while, it would not make much sense to administer the MHC-SF every week. The BSI and SMI are lengthy, hence, filling these out every week would be time-consuming and burdensome for patients. After follow-up, 15 patients will be interviewed by a researcher, focusing on the perceived effects of the CAPTs-intervention (see figure 1).
Timeline of test-phase. Note: Visualisation of the MBSCED design. BSI, Brief Symptom Inventory; GSAAS, Generic Sense of Ability to Adapt Scale; MHC-sf, Mental Health Continuum – Short Form; SERATS, Self-Expression and Emotion Regulation in Arts Therapies Scale; SMI, Schema Mode Inventory; T0, start baseline period; T7, start intervention period; T17, start follow-up period.
Measures
Quantitative measures
Primary outcome
Participants’ ability to adapt will be measured using the GSAAS34 consisting of 10 items. Items are phrased as follows: I can cope well with adverse circumstances, and I see plenty of interesting challenges, with responses given on a 5-point Likert scale from not at all (0) to always (4). The total average score reflects the overall sense of adaptability. The scale showed good internal consistency (Cronbach’s α=0.89) and moderate to strong correlations between the GSAAS and concurrent validation measures confirmed convergent validity.34
Secondary outcomes
Self-expression and emotion regulation through the CAPTs
Participants’ capacity for self-expression and emotion regulation through CAPTs will be measured using the SERATS,35 consisting of nine items (e.g., In art therapy, I can express my feelings) measured on a 5-point Likert scale from (almost) never to (almost) always. A single total score is calculated. SERATS has been found to show high internal consistency (Cronbach’s α=0.94) and high convergent validity.35
Schema modes
Participant’s schema modes will be measured using the SMI,36 consisting of 118 items divided into 14 subscales. Items are phrased as follows: I deny myself pleasure because I do not deserve it, and I feel content and at ease, with responses given on a 6-point Likert scale from never or almost never (1) to all of the time (6). The 14 subscales result in acceptable internal consistencies (Cronbach’s α ranges from 0.79 to 0.96).36 The subscales of the adaptive modes, the healthy adult and the happy child, will be measured weekly. The maladaptive modes will be measured twice, before and after the intervention.
Mental well-being
Participants’ well-being will be measured using the MHC-SF,37 consisting of 14 items aimed at positive mental health. The MHC-SF measures three dimensions of well-being: emotional, psychological and social well-being. Items are phrased as follows: In the past week, how often did you feel… (e.g., happy), with responses given on a 6-point Likert scale (from never to every day). The total score of the MHC-SF has sufficient to high internal consistency. Cronbach’s α ranges from 0.76 to 0.91 across studies.38 Confirmatory factor analysis confirmed the three-factor structure of emotional, psychological and social well-being, with convergent validity among these three dimensions.39
Psychological symptoms
The BSI is used to measure psychological symptoms. It consists of 53 items covering nine symptom dimensions and three global indices of distress. The global indices respectively measure the intensity of symptoms, current or past level of symptomatology and number of reported symptoms.40 Items are phrased as follows: In the past week, how often did you experience… (e.g., the idea that another person can influence your thoughts or nervousness) with responses given on a 5-point Likert scale (from not at all (0) to extremely (4)). The BSI shows high total internal consistency (Cronbach’s α 0.96).41
Qualitative measures
Experts by Experience in Step 1 of IM will complete an online survey. They will be asked about their experiences with CAPTs, talking therapy and SFT in general. Questions will be phrased as follows: what has CAPTs helped you with or what has talking therapies helped you with. The survey will also consist of statements to be answered on a 5-point Likert scale (from absolutely true to not at all true). Items are phrased as follows: Multiple forms of CAPTs in the yet-to-be-developed intervention have added value compared with one CAPTs and CAPTs helps with sensing body signals. In addition, they will be asked about their preferences and needs in working on psychological adaptability and well-being.
CAPTs-therapists, psychologists and managers will participate in focus groups, using the method of Raats.42 In Step 1 of IM they will be asked about what the intervention should look like, working mechanisms of CAPTs and their knowledge about psychological adaptability. In Step 6, they will be asked about their experiences and the use and effects of the CAPTs-intervention.
Participating patients in Step 6 of IM will be asked about their experiences with the CAPTs-intervention. The patients will be interviewed individually using a semi-structured interview based on the change interview, focusing on identifying change processes in therapy.43 An interview guide with a topic list will be used to prevent important topics from being neglected. The aim of the interview is to evaluate the experience with the CAPTs-intervention.
Data management
Researchers from the Research Group for Arts and Psychomotor Therapies in Healthcare at the HAN University of Applied Sciences will manage the data in accordance with the 'FAIR Guiding Principles for Scientific Data Management and Stewardship'. A data management plan has been assessed and approved by the ethics committee (ECO 471.07/23) of the HAN University of Applied Sciences. Data will be stored on a secured research drive and entered twice to ensure accuracy. Informed consent forms will be stored on a secured research drive of the HAN University of Applied Sciences. The research team will be able to access participant data based on participant number only. Only the research team will have access to the final data set.
Data analysis
Demographic and clinical characteristics
Participants’ demographic and clinical characteristics will be summarised with descriptive statistics (means and SDs for interval variables, median and IQR for ordinal variables, numbers and percentages for nominal variables). The following demographics of participants will be reported: age, gender, diagnosis (type of PD) and number of CAPTs sessions attended. Of the participating therapists, the following demographic data will be reported: age, gender, CAPTs discipline, years of working experience, target population and setting.
Quantitative data
First, quantitative data will be visually analysed. Individual participants’ graphs will be inspected to compare the intervention period with the baseline period and follow-up period using the step-by-step guide of Lane and Gast.44 After this, the quantitative data will be analysed using MultiSCED. This is an application built with Shiny,45 a framework to create interactive web apps that provide a user-friendly interface for R functionalities.46 The application will allow for the analysis of repeatedly measured data collected at 16–18 time points. The outcomes as measured by the GSAAS, MHC-SF, SERATS, SMI and BSI are the dependent variables. These outcomes reflect clinical symptoms and well-being. Phase (baseline vs treatment period) will be included. Additionally, time and the interaction between them (time×phase) can be included as the independent variables.
Two analyses will be performed in MultiSCED. First, analysis at the level of aggregated data involves a linear mixed model. A random intercept and slope will be included to account for the dependence of observation within participants at different point of time. Mean differences in outcomes between the baseline period, intervention period and follow-up period will be calculated. Hypothesis testing for the fixed effects of linear mixed models in MultiSCED will be performed using a t-test with the Kenward and Roger approximation for df.47 Linear mixed models are well equipped to handle missing data under the assumption of ‘missing at random’. In the primary analysis, we will adopt an intention-to-treat approach that includes all participants, regardless of treatment fidelity, therapy compliance and being lost to follow-up. The secondary analysis will include only those participants with adequate treatment fidelity and compliance. In a sensitivity analysis, the robustness of the findings will be analysed by repeating the analysis only with those participants without missing data (complete-case analysis) and without multivariate outliers. Second, an analysis will be performed at the level of the individual participants. MultiSCED provides participant-specific regression coefficients, together with their SEs, t values and p values. Mean differences in outcomes between the baseline period, intervention period and follow-up period will be calculated.
Since the MHC-SF, BSI and SMI (complete) will only be administered twice (T7 and T16), the mean within-subject difference over time for these measures will be tested using a paired sample t-test. In all analyses, an α of 5% will be adopted.
Qualitative measures
The results of the survey will be analysed in ATLAS.ti for Windows (V.24.0). The focus groups with the therapists, the interviews with managers and psychologists, as well as the interviews with participants and therapists, will be audio-recorded, transcribed verbatim and analysed in ATLAS.ti. Consistent with the principles of Thematic Analysis,48 we will use the six phases of analysis: (1) get familiar with the data, (2) create initial codes, (3) search for themes, (4) assess potential themes, (5) define and name the themes, and (6) reporting.
Integration of quantitative and qualitative results
Individual MBSCED trajectories will be analysed through the lens of the interview outcomes. Interpersonal and intrapersonal similarities and differences in outcomes will be explored. Based on these findings, the effectiveness of the CAPTs-intervention will be assessed, and recommendations made regarding its use in clinical practice.
Monitoring
This study has an external advisory board consisting of a psychologist, a manager of one of the mental health facilities, a psychology professor from the University of Twente, a music therapist (who is also an Expert by Experience), a patient representative of the Client Advisory Board of the Dutch Federation of Arts Therapies, and a patient and relatives representative of MIND, a national platform for people in mental healthcare (who is also an Expert by Experience). The external advisory board will meet with the principal researcher every 3 months during the project period.
The intervention will be created by two art therapists. To ensure that the intervention connects with professional practice, the outcomes of the focus groups with CAPTs-therapists will be used to develop the intervention. Subsequently, the working methods in the intervention will be presented to a few CAPTs-therapists of every discipline to check if they fit the goals of the sessions. Later, the intervention will be tested with a group of students and patients and the experiences will be collected. Based on this, the intervention will be adjusted again. In this way we ensure that the quality of the intervention remains guaranteed.
One of the researchers will monitor weekly whether participants fill out the questionnaires. If necessary, participants will be contacted and requested to complete the questionnaires and therapists will help to remind them to complete the questionnaires. In addition to the questionnaires, a researcher will ask participants how they are doing halfway through the intervention. This is to monitor the well-being of the participants and manage adverse events. The question will be asked by a researcher to prevent the participant from giving socially desirable answers to the therapist.
The participating therapists will receive supervision from another art therapist every 3 weeks. Here they can discuss how the implementation of the intervention is going, what they encounter and how they experience the implementation.
Patient and public involvement
Patients’ representatives of the Client Advisory Board of the Dutch Federation of Arts Therapies and MIND will be involved in the development of the study proposal and research question. In addition, we will develop a questionnaire about their experiences with psychotherapy and CAPTs. We will use the outcomes in the intervention’s development.
Ethics and dissemination
The local medical ethical committee (METC Oost-Nederland) indicated that this study is not subject to the Dutch Medical Research Involving Human Subjects Act (2023–16438). The study was approved by the official Research Ethics Committee of the HAN University of Applied Sciences (ref: ECO 471.07/23). All participants will be given study information through an information letter and verbal explanation by the researcher before written informed consent was obtained. Personal data will be processed confidentially in encrypted files and stored on a secured research drive of the HAN University of Applied Sciences. Any deviation from the study protocol will be described in an appendix in the final publication. Study results will be disseminated to professionals and students through presentations and publications. Also, results will be disseminated to the study participants on request. Access to the full participant-level dataset will be handled by the principal investigator on reasonable request.
Supplemental material
Ethics statements
Patient consent for publication
Acknowledgments
We are grateful to Regieorgaan SIA for making this research possible. Additionally, we would like to thank Arjan Doolaar for checking the reference list.
References
Footnotes
Contributors SH, KT, HW and JH conceived of the presented idea. SH, ICMW, KT, HW, JH, MR and GJW contributed to the design and the writing of the study protocol. KT and ICMW carried out the ethical procedures. SH, KT, ICMW and JH will take care of the implementation of the research. SH and KT will develop the intervention. ICMW and KT will monitor the therapists’ procedures and patients’ procedures. HW and KT will conduct the statistical analysis. SH as principal investigator oversees the research process and connects with the advisory board. ICMW wrote the first draft of the manuscript, SH, KT, HW, JH, MR and GJW critically reviewed the manuscript for intellectual content. SH is responsible for the overall content as guarantor.
Funding This study is funded by Regieorgaan SIA: Raak Publiek (RAAK.PUB10.003). The study funder is not involved in the execution of the study, in data analysis and interpretation or in the decision to submit results.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.