Personality DisordersB-DITNCT06471010
B-DIT Feasibility Study
An observational study of Personality Disorders, run by De Viersprong at 1 site in Netherlands.
Trial summary
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personality Disorders
- What is being tested?
- Blended Dynamic Interpersonal Therapy (B-DIT)
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jun 2024to Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clients referred to De Viersprong are eligible for B-DIT when they exhibit mild to moderately severe impairments in personality functioning (including both cluster B, C, or a mixed presentation within unspecified personality disorder). Clients typically present with persistent problems in specific areas of their functioning, and typically have had previous, unsuccessful treatments. Adequate functioning in at least one domain of life (such as family, work, other societal roles) should be ensured, which allows for the generalization of treatment gains during and after the relatively short-term/ low intensity intervention. All patients that are referred to B-DIT at de Viersprong are eligible for the study.
Who may be able to join
- 18 years of age or older
- mild to moderately severe impairments in personality functioning, including both cluster B and cluster C personality problems as well as a mixed presentation within unspecified personality disorder.
- General exclusion criteria for treatment at the Viersprong:
- insufficient proficiency in the Dutch language
- no permanent place of residence
- intellectual disability (IQ < 80)
Show all 15Show fewer
- organic brain disorder
- autism spectrum disorders
- schizophrenia or schizophreniform disorder
- (untreated) eating disorder, extreme obesity, or a BMI < 17.5
- (untreated) addiction.
- Additional exclusion criteria for the B-DIT treatment:
- acute risk of crisis requiring stabilizing/crisis interventions
- Severe PTSD or the severe range of personality problems (structural: low-level borderline organization).
- There are no additional inclusion/exclusion criteria for participation in the study, other than those that apply to treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effectiveness of Blended Dynamic Interpersonal Psychotherapy for Personality Pathology
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. Blended interventions have the potential to improve treatment accessibility and cost-effectiveness for individuals with personality pathology and promote a sense of agency and ownership among clients regarding their treatment as compared to traditional Face-to-Face (FTF) approaches. This may improve treatment outcome and recovery.
The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, integrates FTF therapy and online modules into a cohesive treatment program. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases.
Read more
The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and an interview-based qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The research questions are as follows:
- How acceptable is the blended treatment program, B-DIT, for adult clients with personality pathology and their therapists?
- What is the effectiveness of B-DIT for adult clients with personality pathology in terms of progress in reducing symptom burden, overall functioning, and personality functioning, including changes in process measures such as mentalizing ability, epistemic trust, and agency?
- Exploratively, the effects on these process and outcome measures across treatment phases will be compared to ascertain if observed changes align with the presumed working mechanisms of the intervention.
Read the detailed description
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. B-DIT integrates face-to-face (FTF) therapy and online modules into a cohesive treatment program, offering potential advantages in terms of treatment accessibility and cost-effectiveness for individuals with personality pathology. Additionally, blended interventions may have added value compared to traditional FTF approaches by fostering a greater sense of agency and ownership among clients regarding their treatment. While e-health and blended interventions have demonstrated promising treatment outcomes across various mental health areas, there is limited evidence for interventions targeting personality pathology.
B-DIT, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, addresses this gap and provides a blended intervention for clients with mild to moderately severe personality pathology. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases.
The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and conducting a qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The SCED allows drawing conclusions about effectiveness based on a relatively small sample, while accommodating potential refinements to the intervention during the study period. The following research questions will be addressed:
- How acceptable is a blended treatment program, Dynamic Interpersonal Therapy (B-DIT), for adult clients with personality pathology and for their therapists?
- How effective is B-DIT for adult clients with personality pathology in terms of progress in improving symptom burden, overall functioning, and personality functioning, along with changes in process measures (mentalizing ability, epistemic trust, agency)?
- Exploratively, the effects on these process and outcome measures across treatment phases will be compared to determine if observed changes are consistent with the presumed working mechanisms of the intervention.
Participants in the study will receive care as usual. In complement to regular Routine Outcome Monitoring assessments as integrated part of treatment, participants will be asked to complete an additional 26-item questionnaire repeatedly during their treatment and over a one year follow-up period in a Single Case Experimental Design with four phases:
Phase A - Baseline Waiting List (before start of treatment) - with a minimum of 3 weeks; Phase B - Intensive treatment phase (10 weeks of individual treatment followed by 30 weeks of group treatment) - 30 weeks; Phase C - Booster treatment phase - 16 weeks; Phase D - Follow-up phase after the end of treatment - 12 months.
The (impact of) expectations with regards to their treatment will be assessed at baseline and at end of treatment. Clients and clinicians will be questioned about their experiences in the treatment program (at the end of treatment) by means of semi-structured qualitative interviews.
- Conditions
- Personality Disorders
- Being tested
- Blended Dynamic Interpersonal Therapy (B-DIT)
- Keywords
- Blended treatment, E-health, Psychotherapy, Personality disorder, Personality pathology, Treatment accessibility
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended Dynamic Interpersonal Therapy (B-DIT)Other
The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp (http://www.onlinepsyhulp.be), integrates FTF therapy and online modules into a cohesive treatment program for clients with personality pathology. Both FTF and online treatment components are anchored in the Dynamic Interpersonal Therapy (DIT) framework (Lemma et al., 2011).The program spans three phases: an individual phase lasting approximately two months, followed by a five-month group phase, concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases. Both verbal psychotherapy and art therapy are offered as treatment modalities in the face-to-face treatment sessions. The program is implemented by a multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| B-DIT | Not described Receives: Other: Blended Dynamic Interpersonal Therapy (B-DIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personality functioning- Severity Indices of Personality Functioning
Personality functioning- Severity Indices of Personality Functioning (SIPP-60): a 60-item self-report ROM questionnaire
Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up)
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Personality functioning- Level of Personality Functioning
Personality functioning - Level of Personality Functioning Brief-Form 2.0 (LBFS-BF-2.0): a 12-item self-report ROM questionnaire.
Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up).
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Symptom distress
Brief Symptom Inventory (BSI): a 53-item self-report ROM questionnaire.
Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up)
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Overall functioning
Outcome Rating Scale (ORS): a 4-item self-report questionnaire.
Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED. During:
- Phase A: weekly during the baseline waiting period with a minimum of three weeks.
- Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
- Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
- Phase D: two-monthly during the follow-up phase of 12 months
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Usability of the online portal
System Usability Scale (SUS): a 10-item self-report questionnaire
Measured: End of treatment (end of phase C)
Secondary outcomes (5)
Agency
General Self-Efficacy Scale (GSES): a 10 item self-report questionnaire
Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.
- Phase A: weekly during the baseline waiting period with a minimum of three weeks.
- Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
- Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
- Phase D: two-monthly during the follow-up phase of 12 months
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Epistemic Trust
4 selected items of the Questionnaire Epistemic Trust (QET)
Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.
- Phase A: weekly during the baseline waiting period with a minimum of three weeks.
- Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
- Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
- Phase D: two-monthly during the follow-up phase of 12 months
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Reflective Functioning
Reflective Functioning Questionnaire (RFQ): a 8 item self-report questionnaire.
Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.
- Phase A: weekly during the baseline waiting period with a minimum of three weeks.
- Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
- Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
- Phase D: two-monthly during the follow-up phase of 12 months
Measured: From baseline, throughout the intervention, to 12 months after end of treatment
Treatment expectations
Credibility and Expectancy Questionnaire (CEQ)
Measured: Baseline - after indication for treatment; End of treatment (end of phase C)
Experiences of clients and clinicians
Semi-structured interviews with clients and clinicians
Measured: End of phase C (booster phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start17 Jun 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- De Viersprong
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting tot Steun, OnlinePsyhulp
- Responsible party
- Sponsor
- Investigators
- Maaike L Smits, Dr., Principal investigator, De Viersprong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471010
- Sponsor's protocol ID
- 2024-0085
- Acronym
- B-DIT
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemma A, Target M, Fonagy P. The development of a brief psychodynamic intervention (dynamic interpersonal therapy) and its application to depression: a pilot study. Psychiatry. 2011 Spring;74(1):41-8. doi: 10.1521/psyc.2011.74.1.41.
PubMed 21463169
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of Blended Dynamic Interpersonal Psychotherapy for Personality Pathology
- ClinicalTrials.gov ID
- NCT06471010
- Acronym / sponsor ID
- B-DIT / 2024-0085
- Conditions
- Personality Disorders
- Keywords
- Blended treatment, E-health, Psychotherapy, Personality disorder, Personality pathology, Treatment accessibility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- De ViersprongUniversity, hospital or other
- Collaborators
- Stichting tot Steun, OnlinePsyhulp
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jun 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.
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. Blended interventions have the potential to improve treatment accessibility and cost-effectiveness for individuals with personality pathology and promote a sense of agency and ownership among clients regarding their treatment as compared to traditional Face-to-Face (FTF) approaches. This may improve treatment outcome and recovery.
The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, integrates FTF therapy and online modules into a cohesive treatment program. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases.
The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and an interview-based qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The research questions are as follows:
- How acceptable is the blended treatment program, B-DIT, for adult clients with personality pathology and their therapists?
- What is the effectiveness of B-DIT for adult clients with personality pathology in terms of progress in reducing symptom burden, overall functioning, and personality functioning, including changes in process measures such as mentalizing ability, epistemic trust, and agency?
- Exploratively, the effects on these process and outcome measures across treatment phases will be compared to ascertain if observed changes align with the presumed working mechanisms of the intervention.
Detailed description
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. B-DIT integrates face-to-face (FTF) therapy and online modules into a cohesive treatment program, offering potential advantages in terms of treatment accessibility and cost-effectiveness for individuals with personality pathology. Additionally, blended interventions may have added value compared to traditional FTF approaches by fostering a greater sense of agency and ownership among clients regarding their treatment. While e-health and blended interventions have demonstrated promising treatment outcomes across various mental health areas, there is limited evidence for interventions targeting personality pathology.
B-DIT, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, addresses this gap and provides a blended intervention for clients with mild to moderately severe personality pathology. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases.
The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and conducting a qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The SCED allows drawing conclusions about effectiveness based on a relatively small sample, while accommodating potential refinements to the intervention during the study period. The following research questions will be addressed:
- How acceptable is a blended treatment program, Dynamic Interpersonal Therapy (B-DIT), for adult clients with personality pathology and for their therapists?
- How effective is B-DIT for adult clients with personality pathology in terms of progress in improving symptom burden, overall functioning, and personality functioning, along with changes in process measures (mentalizing ability, epistemic trust, agency)?
- Exploratively, the effects on these process and outcome measures across treatment phases will be compared to determine if observed changes are consistent with the presumed working mechanisms of the intervention.
Participants in the study will receive care as usual. In complement to regular Routine Outcome Monitoring assessments as integrated part of treatment, participants will be asked to complete an additional 26-item questionnaire repeatedly during their treatment and over a one year follow-up period in a Single Case Experimental Design with four phases:
Phase A - Baseline Waiting List (before start of treatment) - with a minimum of 3 weeks; Phase B - Intensive treatment phase (10 weeks of individual treatment followed by 30 weeks of group treatment) - 30 weeks; Phase C - Booster treatment phase - 16 weeks; Phase D - Follow-up phase after the end of treatment - 12 months.
The (impact of) expectations with regards to their treatment will be assessed at baseline and at end of treatment. Clients and clinicians will be questioned about their experiences in the treatment program (at the end of treatment) by means of semi-structured qualitative interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-DIT | – | Other: Blended Dynamic Interpersonal Therapy (B-DIT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clients referred to De Viersprong are eligible for B-DIT when they exhibit mild to moderately severe impairments in personality functioning (including both cluster B, C, or a mixed presentation within unspecified personality disorder). Clients typically present with persistent problems in specific areas of their functioning, and typically have had previous, unsuccessful treatments. Adequate functioning in at least one domain of life (such as family, work, other societal roles) should be ensured, which allows for the generalization of treatment gains during and after the relatively short-term/ low intensity intervention. All patients that are referred to B-DIT at de Viersprong are eligible for the study.
Key inclusion criteria (15 listed)
- 18 years of age or older
- mild to moderately severe impairments in personality functioning, including both cluster B and cluster C personality problems as well as a mixed presentation within unspecified personality disorder.
- insufficient proficiency in the Dutch language
- no permanent place of residence
- intellectual disability (IQ < 80)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blended Dynamic Interpersonal Therapy (B-DIT)The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp (http://www.onlinepsyhulp.be), integrates FTF therapy and online modules into a cohesive treatment program for clients with personality pathology. Both FTF and online treatment components are anchored in the Dynamic Interpersonal Therapy (DIT) framework (Lemma et al., 2011).The program spans three phases: an individual phase lasting approximately two months, followed by a five-month group phase, concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases. Both verbal psychotherapy and art therapy are offered as treatment modalities in the face-to-face treatment sessions. The program is implemented by a multidisciplinary team. | Other | B-DIT |
Primary outcome
Personality functioning- Severity Indices of Personality Functioning
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Personality functioning- Severity Indices of Personality Functioning (SIPP-60): a 60-item self-report ROM questionnaire Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up)
Personality functioning- Level of Personality Functioning
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Personality functioning - Level of Personality Functioning Brief-Form 2.0 (LBFS-BF-2.0): a 12-item self-report ROM questionnaire. Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up).
Symptom distress
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Brief Symptom Inventory (BSI): a 53-item self-report ROM questionnaire. Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up)
Overall functioning
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Outcome Rating Scale (ORS): a 4-item self-report questionnaire. Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED. During: * Phase A: weekly during the baseline waiting period with a minimum of three weeks. * Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment * Phase C: monthly during the third intervention phase (booster phase) of 16 weeks * Phase D: two-monthly during the follow-up phase of 12 months
Usability of the online portal
Time frame: End of treatment (end of phase C)
System Usability Scale (SUS): a 10-item self-report questionnaire
5 secondary outcomes
Agency
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Epistemic Trust
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Reflective Functioning
Time frame: From baseline, throughout the intervention, to 12 months after end of treatment
Treatment expectations
Time frame: Baseline - after indication for treatment; End of treatment (end of phase C)
Experiences of clients and clinicians
Time frame: End of phase C (booster phase)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 21463169Lemma A, Target M, Fonagy P. The development of a brief psychodynamic intervention (dynamic interpersonal therapy) and its application to depression: a pilot study. Psychiatry. 2011 Spring;74(1):41-8. doi: 10.1521/psyc.2011.74.1.41.
- Website of OnlinePsyHulp that developed and facilitates the online treatment modulesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maaike L Smits, Dr. principal investigator
De Viersprong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Disorders, run by De Viersprong 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 15 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Personality functioning- Severity Indices of Personality Functioning (time frame: From baseline, throughout the intervention, to 12 months after end of treatment). The study lists 5 primary outcomes in all. 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 NCT06471010, 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 20 Oct 2026.